COVID-19 Updates

The COVID-19 Safety Task Force has been charged with providing salient updates to enhance the Reopening Office and Resuming Elective Procedures recommendations released May 5, 2020. These updates are collected and reviewed by Task Force members, and will be emailed on a weekly basis.

Updates for the week of April 26, 2021:

Category: COVID-19 Testing
Title: Coronavirus (COVID-19) Update
Source: U.S. Food and Drug Administration
Synopsis: As of April 16, 2021, 363 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 266 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 22 antigen tests. There are 46 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.

Comment: The FDA has authorized 7 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 457 revisions to EUA authorizations.

Category: COVID-19 Vaccine
Title: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The FDA and Centers for Disease Control and Prevention (CDC) issued a Statement regarding the Janssen (Johnson & Johnson) COVID-19 Vaccine. Out of an abundance of caution, the FDA and CDC recommended a pause in the use of this vaccine while we review the data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine. This pause was recommended, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

The FDA and CDC are reviewing data involving six cases reported to the Vaccine Adverse Event Reporting System (VAERS) of a low level of platelets in the blood in combination with a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST) in individuals who had received the Janssen COVID-19 Vaccine. One individual died. All cases occurred in females ranging in age from 18 through 48 years. In some of the reported cases of CVST, blood clots also involved large veins in the abdomen.

Out of an abundance of caution, the FDA and CDC are recommending a pause in the use of the Janssen COVID-19 Vaccine while the FDA and CDC, including through its Advisory Committee on Immunization Practices investigate these reports of serious adverse events. This is important, in part, to help ensure that health care providers are aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required for CVST with low levels of platelets.

Comment: The safety monitoring program that is in place to monitor COVID-19 vaccines is working, as we were able to detect the reports of these very rare, serious adverse events early and take action to assess them. The FDA and CDC will continue to fully investigate all reports to determine if a causal relationship exists.

Category: COVID-19 Testing
Title: FDA Continues to Advance Over-the Counter and Other Screening Test Development
Source: U.S. Food and Drug Administration
Synopsis: Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription. The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These authorizations follow the FDA’s recent actions to advance OTC and other screening test development.

In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week:

Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
Abbott BinaxNOW (multiple configurations)
- Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
- Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor
- Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
- BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

Comment: These tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

These authorizations streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish screening programs.

Category: COVID-19 Treatment
Title: FDA Revokes EUA for Bamlanivimab
Source: U.S. Food and Drug Administration
Synopsis: Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA.

Comment: Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available.

Category: Surgical Issues
Title: Rhinosurgery during and after the COVID-19 Pandemic: International Consensus Conference Statement on Preliminary Perioperative Safety Measures
Source: Plastic and Reconstructive Surgery
Synopsis: This is a level V article (expert opinion) from the Science and Research Committee of the Rhinoplasty Society of Europe. Fourteen very experienced rhinoplastic surgeons had a 3.5 hour Zoom meeting, and tried to come to consensus on common peri-operative issues for functional and aesthetic rhinoplasty.

The results are tabulated at: https://cdn-links.lww.com/permalink/prs/e/prs_147_5_2021_03_08_haug_prs-d-20-02070_sdc1.pdf

Statement with 100% consensus:

Pre-op assessment should include specific screening questions for COVID-19 exposure.
RT-PCR testing for COVID-19 should be routinely performed prior to surgery. Most recommended one test, 2 days prior to surgery.

Statements with 90% or greater consensus:

The informed consent should be adapted for the COVID-19 era.
Routine surgical face masks are inadequate for aerosol-generating examinations or surgical procedures. FFP2/3/N95 masks plus shield were recommended.
Intra-nasal/ pharynx disinfection with either Betadine or Octenisept was recommended. Many also recommended pre-surgical nasal packing with Betadine.

Statements with 80%-90% consensus:

COVID-19 increases complication rates / death after surgery.

While there are more recommendations of interest to surgeons performing rhinoplasty, for the sake of brevity here, we recommend that those surgeons read the article.

Comment: While many of the consensus statements listed here seem fairly routine today, it simply shows just how far our understanding of COVID-19 has come in one year.

Updates for the week of March 29, 2021:

Category: Elective Surgery
Title: The Safe Resumption of Elective Plastic Surgery in Accredited Ambulatory Surgery Facilities During the COVID-19 Pandemic
Source: Aesthetic Surgery Journal
Synopsis: This is a prospective study of 368 patients who underwent elective aesthetic surgery at 6 Ambulatory Surgery Facilities in Ontario, Canada, between June 1 and July 17, 2020. Five of 6 centers were in the Metro Toronto area. All patients were screened for COVID-19 symptoms by questionnaire, and 95% of them had preoperative COVID-19 PCR testing 3-4 days prior to surgery. The patients were asked to isolate themselves between testing and surgery. None of the preoperative COVID-19 tests were positive. No patients self-reported development of COVID-19 or COVID-like symptoms in the 30 days following surgery, and there were no cases of transmission of COVID-19 to healthcare workers involved in the procedures. The authors conclude that elective aesthetic plastic surgery can be safely performed for both patients and healthcare providers, given appropriate pre-operative symptom screening and universal pre-op COVID-19 testing.

Comment: This adds another article from Canada about the safety of plastic surgery during the pandemic to the published articles from the experience in Texas.

Category: Elective Surgery
Title: Evaluating Postoperative Outcomes of Patients Undergoing Elective Procedures in an Ambulatory Surgery Center During the COVID-19 Pandemic
Source: Aesthetic Surgery Journal
Synopsis: A total of 300 consecutive elective cases in an ASC in Dallas, TX between March 1, 2020 and April 16, 2020 were retrospectively reviewed in this study. The median age of the cohort and procedure time was 54.6 years and 47 minutes, respectively. The most common anesthesia modalities were intravenous sedation (56.3%), followed by general anesthesia (32%), monitored anesthesia care (8%), and blocks (2.7%). The mean follow-up time was 6 weeks postoperatively. The most common procedures were:

Pain management – 43%
GI – 26%
Aesthetic – 14%
Orthopedic – 10.3%
Reconstructive – 4%
Otorhinolaryngology – 2%
Gynecology - .67%

The primary outcomes were occurrence of COVID-19 related postoperative complications which included pneumonia, stroke, myocardial infarction, and clotting disorders. In the cohort of 300 elective cases, no patients were found with COVID-19 related symptoms postoperatively.

Comment: No COVID-19 related complications were identified in a cohort of 300 patients who underwent elective procedures at an ASC following a strict preoperative screening protocol. This study suggests that with careful preoperative screening and patient selection with specific assessment, elective procedures can be performed safely for patients and healthcare personnel in an ambulatory surgery center during this pandemic.

Category: Elective Surgery
Title: Timing of surgery following SARS‐CoV‐2 infection: an international prospective cohort study
Source: Anesthesia
Summary: Although it is known that preoperative COVID-19 infection increases mortality, the optimal duration of planned delay before surgery in patients who have had COVID is not clear. This multicenter, prospective study looked at 140,000 patients in 116 countries, of which 2.2% had a preoperative COVID diagnosis. Logistic regression models were used to calculate 30-day mortality rates, stratified by time from the diagnosis of COVID.

Patients operated within 6 weeks of their COVID diagnosis were at an increased risk of 30‐day postoperative mortality and 30‐day postoperative pulmonary complications. These risks decreased to baseline levels in patients who underwent surgery ≥ 7 weeks after COVID diagnosis. These findings were consistent across both low‐risk (age < 70 years, ASA physical status 1–2, minor surgery) and high‐risk (age ≥ 70 years, ASA physical status 3–5, major surgery) sub‐groups.

The authors concluded that surgery should be delayed for at least 7 weeks following COVID infection to reduce the risk of postoperative mortality and pulmonary complications. In addition, patients who are still symptomatic ≥ 7 weeks after COVID infection and undergo surgery also have an increased mortality rate, and may benefit from an even longer delay.

Comment: The 7 week rule applied uniformly to young patients, to ASA I & II, and to minor and elective surgery categories in this analysis, all of which are typical plastic surgery patients. This advice differs from prior recommendations given by the American Society of Anesthesiologists / APSF, which suggested a 4 week delay for mild, non-respiratory symptoms, and 6 weeks for a symptomatic patient who did not require hospitalization.

Category: Elective Surgery
Title: SARS‐CoV‐2 infection, COVID‐19 and timing of elective surgery
Source: Anesthesia
Synopsis: This is a consensus statement from the Royal College of Anesthetists, the Royal College of Surgeons of England, and several other important UK-based medical groups. It is based on a systematic review of the literature and expert opinion regarding recommendations about surgery, anesthesia and COVID. The article reviews such concepts as pre-operative immunization, universal PCR testing prior to surgery, the 7-week rule for delaying elective surgery in patients with prior COVID infection, and the other well-known strategies to reduce the chance of peri-operative COVID infection for staff and patients.

Comment: An excellent summary paper. While there is nothing “new" here that the COVID-19 task force hasn’t already highlighted, it is a nice all-in-one document that all surgeons should read. It shows how far we’ve come in our understanding in the past year.

Category: COVID-19 Symptoms
Title: Attributes and Predictors of Long COVID
Source: Nature
Summary: Although the “long COVID” syndrome is recognized, little is known about the prevalence, risk factors, or predictability of a protracted course of COVID. Short COVID is defined as symptoms lasting 10 days or less, whereas long COVID has symptoms for 28 days or more. This study evaluated 4182 PCR positive patients in the UK, US and Sweden, who prospectively self-reported their symptoms into a computerized database, with COVID negative patients used as controls.

In this study, 13.3% had symptoms lasting >28 days, and 4.5% had symptoms for >56 days, typically fatigue, headache, dyspnea and anosmia. Palpitations and tachycardia were reported by 6%, memory issues by 4%. Tinnitus and peripheral neuropathy were also reported.

The strongest predictor for Long COVID (>28 d) was increasing age, rising from 9.9% in the 18-49 year old group to 21.9% in those 70+. Having more than 5 symptoms during the first week of illness was strongly associated with long COVID. It was also associated with higher BMI, female sex, and pre-existing asthma. Patients with Long COVID were more likely to have relapsing symptoms.

Comment: This study adds to our understanding of the Long COVID syndrome, and shows that it is not a rare complication of the acute disease. Surgeons should be aware of the symptoms.

Category: COVID-19 Testing
Title: Universal preoperative SARS-CoV-2 testing can facilitate safe surgical treatment during local COVID-19 surges
Source: British Journal of Surgery
Summary: This research letter details the experience of University of Texas MD Anderson Cancer Center’s approach to universal screening and COVID-19 testing for patients who required time-sensitive oncologic surgery, from April 6 and July 24, 2020. Following symptom screening, all 4649 patients were PCR tested within 72 hr of planned surgery. Test positivity rates reflected community rates, with up to 4% of preoperative tests being positive during a community surge in COVID-19.

No patient who had surgery after a negative preoperative COVID test developed confirmed COVID 19 within 2 weeks of their operation. There were no confirmed cases of surgical patient to patient, or patient to provider transmission.

Comment: The authors concluded that universal preoperative testing for COVID “allowed the safe continuation of surgery at a large cancer center in the USA”. They recommend ongoing universal preoperative COVID testing, even when community prevalence is low.

Category: COVID-19 Testing
Title: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
Source: U.S. Food and Drug Administration
Synopsis: The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample by people age 14 years and older or people age 8 years and older, when the nasal swab sample is collected by an adult, within the first six days of the onset of COVID-19 symptoms.

Comment: This is one of 15 antigen tests. Remember, antigen tests are not as accurate as PCR tests. Most hospitals and surgery centers that are requiring pre-operative COVID-19 testing, are using molecular PCR tests within three days of the surgery.

Category: COVID-19 Testing
Title: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. A positive test result indicates recent or prior infection with SARS-CoV-2, while a negative test result indicates that a patient is unlikely to have been infected with SARS-CoV-2. Negative results do not preclude acute or current SARS-CoV-2 infection. All results from the test should be used in combination with a clinical examination, patient medical history and other findings. The T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.

Comment: A T cell response may be detected in blood several days after initial infection; however, it is unknown how long the T cell immune response remains following infection and what level of protection may be provided by the presence of a T cell immune response. The T-Detect COVID test will be a useful tool to help determine if a person previously had COVID-19. This is especially important for people who may have exhibited symptoms previously or believe they have been exposed but have not tested positive for COVID-19 using a molecular or antigen diagnostic test.The test is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset. Testing is currently limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet the requirements to perform high complexity tests.

Category: COVID-19 Testing
Title: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens. With the granting of the De Novo for the BioFire RP2.1 today, the FDA has also revoked the EUA for this device, which was initially authorized for emergency use in May 2020.

The BioFire RP2.1 is for use only in individuals suspected of respiratory tract infections, including COVID-19. This diagnostic test is for the detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection and aids in the diagnosis of respiratory infection if used along with other clinical and epidemiological information.

Comment: Below is a list of potential pathogens which can be diagnosed with this new technology:

Adenovirus
Coronavirus NL63
Coronavirus OC43
Human Metapneumovirus
Influenza A
Sample Type and Volume Requirements
Influenza A/H1
Influenza A/H1-2009 Parainfluenza Virus 1 Parainfluenza Virus 3 Respiratory Syncytial Virus
Bordetella pertussis
Mycoplasma pneumoniae
Coronavirus HKU1
Influenza A/H3
Chlamydophila pneumoniae
Coronavirus 229E
Influenza B
Bordetella parapertussis
Coronavirus SARS-CoV-2
Parainfluenza Virus 2
Human Rhinovirus/Enterovirus
Parainfluenza Virus 4

This is a potential differential diagnostic game changer for the physician in the emergency room, physician office, and or private surgical center.

Updates for the week of March 8, 2021:

Category: COVID-19 Vaccine
Title: FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Comment: This is the widely anticipated vaccine from Johnson & Johnson. This is a single dose vaccine which has 66% effectiveness against moderate to severe COVID-19. The CDC expects the 3.9 million Janssen doses will likely be divided as follows: 2.8 million doses for states, 800,000 doses for retail pharmacies, 70,000 doses for community vaccine centers, and 90,000 doses for federally qualified health centers.

Category: COVID-19 Treatment
Title: The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro
Source: Antiviral Research
Synopsis: Although several clinical trials are now underway to test possible therapies, the worldwide response to the COVID-19 outbreak has been largely limited to monitoring/containment. We report here that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 h post infection with SARS-CoV-2 able to effect ~5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrants further investigation for possible benefits in humans.

Ivermectin is an inhibitor of the COVID-19 causative virus (SARS-CoV-2) in vitro. A single treatment able to effect ~5000-fold reduction in virus at 48 h in cell culture.
Ivermectin is FDA-approved for parasitic infections, and therefore has a potential for repurposing.
Ivermectin is widely available, due to its inclusion on the WHO model list of essential medicines.

Comment: There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

Category: COVID-19 Vaccine
Title: BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
Source: New England Journal of Medicine
Summary: All persons who were newly vaccinated in a nationwide Israeli health campaign between December 20, 2020, to February 1, 2021 were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic COVID-19, COVID-19–related hospitalization, severe illness, and death.

Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose, and at 7 or more days after the second dose were as follows:

- for documented infection, 46% and 92%;
- for symptomatic Covid-19, 57% and 94%;
- for hospitalization, 74% and 87%;
- and for severe disease, 62% and 92% .

Comment: This study in a nationwide mass vaccination campaign suggests that the BNT162b2 mRNA vaccine is highly effective in real world settings for a wide range of COVID-19–related outcomes. This is consistent with the findings of previous randomized trials performed during vaccine development.

Category: COVID-19 Treatment
Title: IDSA Guidelines on the Treatment and Management of Patients with COVID-19
Source: Infectious Disease Society of America
Synopsis: Among hospitalized adults with progressive severe* or critical** COVID-19 who have elevated markers of systemic inflammation, the IDSA guideline panel has recently (2/17/21) suggested tocilizumab in addition to standard of care (i.e., steroids) rather than standard of care alone. (Conditional recommendation, Low certainty of evidence)

In the largest trial on the treatment of tocilizumab, criterion for systemic inflammation was defined as CRP ≥75 mg/L.

Severity definitions:
*Severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen.
**Critical illness is defined as patients on mechanical ventilation and ECMO. Critical illness includes end organ dysfunction as is seen in sepsis/septic shock. In COVID-19, the most commonly reported form of end organ dysfunction is ARDS.

Comment: Some patients with COVID-19 develop a hyperinflammatory syndrome that is characterized by elevations in proinflammatory cytokines and multiorgan dysfunction also known as the immunopathology of SARS-CoV-2 infection. The significance of these findings is unclear, however early descriptions found that those with elevated IL-6 levels and evidence of hyperinflammation had increased rates of more severe disease [89, 90]. Tocilizumab, a monoclonal anti-IL-6-receptor blocking antibody, has been proposed as a therapeutic agent to mitigate hyperinflammation associated with COVID-19. Tocilizumab is FDA-approved for various rheumatologic conditions as well as cytokine release syndrome associated with CAR-T cell therapy.

Category: Elective Surgery
Title: Utility of D-dimer in predicting venous thromboembolism in non-mechanically ventilated COVID survivors
Source: Thrombosis Research
Synopsis: Although D-dimer has been found to be a prognostic factor for VTE in severely-ill ventilated COVID patients, less is known about its utility in those with a non-severe course. This single center retrospective study from an NYC teaching hospital used logistic regression to examine the association between admission d-Dimer levels and VTE diagnosis either during admission or within 14 days after discharge in 2630 mild-moderate COVID-19 patients. Patients with subsequent VTE were more likely to be male, and have a higher baseline WBC.

Admission D-dimer > 5 ug/mL occurred in 11.6% of the study group, and had a 10.7 x baseline odds ratio of VTE, p<0.001.

Although not statistically significant, D-dimer levels between 1-2 ug / mL also increased the odds of VTE to 2.3 x baseline (p=0.1) and those between 2-5 ug/mL to 2.9 x baseline (p=0.06). D-dimer appeared to have utility in predicting VTE risk in acute COVID, even in milder cases. Increased levels correlated with increased VTE risk in this study.

Comment: Although recently published reports have suggested using D-dimer as part of a comprehensive preoperative workup prior to subsequent elective surgery in long-term COVID-19 survivors, we do not yet have hard data. It does seem a reasonable precaution to include this test in those scheduled for major procedures under general anesthesia, if their prior COVID-19 case was significant enough to require hospitalization, and to have a discussion with a local hematologist in the event of an abnormal result.

Category: COVID-19 Vaccine
Title: SBI Recommendations for the Management of Axillary Adenopathy in Patients with Recent COVID-19 Vaccination
Source: Society of Breast Imaging
Synopsis: SBI considerations for the management of axillary adenopathy in patients with recent COVID-19 vaccination:

Consider obtaining the following information on patient intake forms: COVID-19 vaccination status, timing and side (left vs. right arm) of vaccination. To minimize patient anxiety, consider including this introductory statement: Vaccines of all types can result in temporary swelling of the lymph nodes, which may be a sign that the body is making antibodies in response as intended.
Unilateral axillary adenopathy on screening exams warrants a BI-RADS category 0 assessment to allow for further assessment of the ipsilateral breast and documentation of medical history, including COVID-19 vaccination.
Following appropriate diagnostic work up for unilateral axillary adenopathy in women who received a COVID-19 vaccination in the ipsilateral upper extremity within the preceding 4 weeks, consider a short term follow up exam in 4-12 weeks (BI-RADS category 3) following the second vaccine dose.
If axillary adenopathy persists after short term follow up, then consider lymph node sampling to exclude breast and non-breast malignancy.

Comment: SBI considerations for patients and providers scheduling screening exams: If possible, and when it does not unduly delay care, consider scheduling screening exams prior to the first dose of a COVID-19 vaccination or 4-6 weeks following the second dose of a COVID-19 vaccination.

Updates for the week of January 25, 2021:

Category: COVID-19 Treatment
Title: Antithrombotic Therapy in Patients with COVID-19
Source: National Institutes of Health (NIH)
Synopsis: The above reference is a summary of recommendations from the NIH (last updated 12/17/20) for deep venous thrombosis (DVT) and venous thromboembolism (VTE) screening, prophylaxis, and treatment for both hospitalized and ambulatory patients with COVID-19. Many of the recommendations are for adults but there are also specific recommendations and precautions for pregnant and lactating women as well as children with COVID-19.

This information is important as there is a well-documented association between COVID-19 and DVT/VTE. Specifically, the prevalence of VTE in hospitalized COVID-19 patients is between 14-40%. While the prevalence of VTE is high in this population, we must remember that the prevalence of non-COVID-19 hospitalized patients who received VTE prophylactic anticoagulation was 5-16% for all patients and up to 37% in critically ill patients. Many of the recommendations for COVID-19 patients come from previous studies of hospitalized non-COVID-19 patients. The article synthesizes available COVID-19 data and the aforementioned non-COVID-19 data and offers recommendations. Below is a condensed list. For a complete list, please refer to the hyperlink above.

Screening:

There is no evidence to support routine DVT/VTE ultrasound screening in patients with COVID-19 at this time. In contrast, hospitalized COVID-19 patients who are deteriorating, DVT/VTE should be suspected and worked-up accordingly.
Nonhospitalized patients should not be routinely tested for markers of coagulopathy while there is no evidence for or against hematologic testing while hospitalized for COVID-19.

Prophylaxis:

Hospitalized non-pregnant COVID-19 patients should be given standard VTE prophylactic doses while in the hospital unless contraindicated.
Discharged patients should not be routinely continued on VTE prophylaxis.

Treatment:

There is insufficient data either for or against the use of therapeutic or higher than prophylactic doses of anticoagulation for VTE for hospitalized COVID-19 patients.
COVID-19 patients who are on chronic anticoagulation and antiplatelet medications should stay on their therapies.

Children:

Indications for VTE prophylaxis in hospitalized children with COVID-19 should be the same as those without COVID-19.

Pregnant and Lactating women:

If hospitalized, pregnant and lactating women should be given prophylactic anticoagulation if not contraindicated.
If anticoagulation therapy is prescribed during pregnancy prior to a COVID-19 diagnosis, it should be continued.

Comment: COVID-19 has been associated with a prothrombotic state with high rates of DVT/VTE. This article offers recommendations for prophylaxis, screening, or treatment of COVID-19 positive patients of different demographic groups. Based on current data available, treatment should generally follow our treatment algorithms for non-COVID-19 hospitalized patients. That being said, hospitalized COVID-19 patients who are deteriorating should be suspected and worked-up for DVT/VTE given their risk profile.

Category: COVID-19 Guidance
Title: Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Hypercoagubility has been observed in patients with COVID-19. The guidance is intended to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measurement of whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the COVID-19 public health emergency.

Comment: We know that clotting disorders are more prevalent after COVID-19 infections. The seriousness of the thrombotic event seems to be related to the seriousness of the COVID-19 infection. These thrombotic events affect the lungs, the heart, the peripheral cardiovascular system, and possibly many other major organ systems. This new guidance as previously outlined in the summary will help guide treatment protocols. As of this date, there are no definitive treatment parameters amongst the medical community. Many different agencies and medical specialties have their own guidelines. Hopefully, the efforts by the FDA will allow all of us to come to agreement on more definitive recommendations for diagnosis and treatment of post COVID-19 thrombotic phenomenon.

Category: COVID-19 Therapies
Title: COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued a temporary guidance entitled, “COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.” This guidance describes methods that applicants should use to ensure the potency of monoclonal antibodies and other therapeutic proteins proposed for use as anti-infective agents for COVID-19. The FDA issued this guidance to help development of monoclonal antibodies and other therapeutic proteins for use as COVID-19 therapeutics."

Comment: Monoclonal antibodies have certainly found their place in the treatment of hospitalized patients with COVID-19. The aforementioned guidelines will promote greater efficacy of monoclonal antibodies. With a recent reporting of new strains of COVID-19, this will provide a greater armamentarium of monoclonal antibodies to treat various strains of COVID-19.

Category: COVID-19 Syndrome
Title: Post-acute COVID-19 Syndrome. Incidence and risk factors: a Mediterranean cohort study
Source: Journal of Infection
Synopsis: 277 PCR-confirmed COVID-19 survivors were evaluated 10-14 weeks after disease onset. Post-COVID syndrome (PCS) was defined as the persistence of at least one clinically relevant symptom, or abnormalities in either spirometry or chest radiology. PCS was detected in 50.9% of patients, with mostly mild symptoms. Radiological and spirometric changes were mild and observed in 19% and 9%, respectively. No baseline clinical features behaved as independent predictors of Post-acute COVID-19 syndrome development.

Comment: A post-COVID syndrome, although mild, may be more common than previously thought. Consideration to pre-operative CXR and PFT’s during a pre-operative evaluation should be given to all survivors, especially those with lingering symptoms.

Updates for the week of January 11, 2021:

Category: COVID-19 Vaccine
Title: FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Source: U.S. Food and Drug Administration
Synopsis: The FDA has followed discussions and news reports regarding dosing of the two vaccines which are now being used for COVID-19. Some of these reports talk about reducing the number of doses, extending the length of time between doses, changing the dose to half dosing, or mixing and matching vaccines in order to immunize more people against COVID-19. However, the FDA wants to emphasize that the FDA authorized dosing and schedules are supported by extensive evidence. The aforementioned reports are not supported by such extensive evidence. To be clear, for the Pfizer COVID-19 vaccine, the interval is 21 days between the first and second dose and for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.

Comment: This schedule must be followed to allow for optimal efficacy of the vaccine which allows the immune response to be optimal; otherwise, patients may assume they are fully protected when they are not and potentially alter their behavior to take unnecessary risks. The FDA has invested an enormous amount of time to make decisions based on data and science. They strongly encourage healthcare providers to follow the FDA authorized dosing schedule for each COVID-19 vaccine.

Category: COVID-19 Updates
Title: FDA Announcement of Coronavirus Aid and Consumer Protections
Source: U.S. Food and Drug Administration
Synopsis: The FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) intended to increase the FDA’s ability to identify, prevent, and mitigate possible drug shortages by enhancing the FDA’s visibility into drug supply chains.

The FDA released a new episode of its podcast, FDA Insight, discussing drug compounding and its contribution to fighting COVID-19.

As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Coco's Holistic Specialties & Apothecary for selling unapproved drug products with fraudulent COVID-19 claims. The company sells tea products, including “4-Thieves Florida Tea Concentrate” and “4-Thieves Florida Tea Powder”, and misleadingly represents that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Coco's Holistic Specialties & Apothecary immediately address its violations from selling these unapproved products for treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

Testing updates: As of January 4, 2021, 235 molecular tests, 64 antibody tests, and 11 antigen tests are available. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

Comment: It is very important to monitor drug and vaccine availability and the supply chains to ensure equal distribution. The over-the-counter at home antigen test by Ellume was touted as “a major milestone in diagnostic testing for COVID-19.” This is a fully at-home rapid lateral flow antigen test which does not require a prescription. It requires an anterior nasal swab and results are available in 20 minutes by using a smartphone. This will be a game changer for potential testing of pre-operative patients. It is accurate identifying 96 percent of positive samples and 100 percent of negative samples in symptomatic patients. And it identifies 91 percent of positive samples and 96 percent of negative samples in asymptomatic patients.

Category: COVID-19 Vaccine
Title: South African Covid variant appears to ‘obviate’ antibody drugs, Dr. Scott Gottlieb says
Source: CNBC
Synopsis: The South African variant is also known as 501.V2, and in mid-December officials reported that 501.V2 had been largely replacing other strains of the coronavirus as early as November. “The South Africa variant is very concerning right now because it does appear that it may obviate some of our medical countermeasures, particularly the antibody drugs,” Dr. Scott Gottlieb said.

Comment: Recently approved monoclonal antibody drugs may not be effective against The COVID-19 South African variant. Casirivimab and Imdevimab used in combination and Bamlanivimab used alone have received emergency use authorization by the FDA to treat COVID-19 infection which requires hospitalization. However, there is no indication that the antiviral drug Veklury (Remdesivir) is ineffective against the COVID-19 South African variant. The new COVID-19 Vaccines will still be effective against the COVID-19 South African variant. The United Kingdom COVID-19 variants are now ubiquitous in the United States and are not showing an increase in morbidity or mortality; however, they may be more infectious. The United Kingdom COVID-19 variants do respond to monoclonal antibody therapy and antiviral therapy as outlined above.

Category: COVID-19 Viral Mutation
Title: Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
Source: U.S. Food and Drug Administration
Synopsis: The FDA is alerting clinical laboratory staff and health care providers that it is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant.

Comment: The United Kingdom COVID-19 variant is now ubiquitous in the United States; however, it does not appear to cause an increase in morbidity or mortality. It is responsive to monoclonal antibody therapy and antiviral therapy. It is important to realize that viral genetic mutation is common and expected.

Category: COVID-19 Vaccine
Title: Maintaining Safety with SARS-CoV-2 Vaccine
Source: New England Journal of Medicine
Synopsis: A review article, focused on immediate allergic responses to the 6 COVID-19 vaccines that are either under EUA or in late phase studies. Of greatest concern, the anaphylactic reaction with flush, pruritus, urticaria, angioedema, tachycardia and laryngeal edema, which is estimated to occur in approximately 1: 100,000 with the new COVID-19 vaccines. This rate is higher than the 1:1,000,000 rate typically seen with prior types of vaccines. The reported cases to date suggest an IgE-mediated process, suggesting prior sensitization to one of the components in the vaccine. Allergic reactions are primarily related to the excipients (preservatives and stabilizers) used in vaccine production, which are listed in the paper. The PEG 2000 molecule is the most likely source of allergy. This is a lipid-based nanoparticle carrier, which prevents the rapid enzymatic degradation of mRNA, prolonging the half-life of the vaccine, in both the Moderna and Pfizer-BioNTech versions of the vaccine. The authors recommend that patients with a prior history of reactions to either PEG-2000 or related polysorbate products (also used in the AstraZeneca vaccine) avoid the vaccines until more information is available.

Comment: Polyethylene glycol (PEG) is a component of the COVID-19 Vaccines. Polyethylene glycol compounds are widespread in household products from skin care and cosmetics, to baby wipes and cleaners. They are used as thickeners, softeners, moisture caring agents, penetration enhancers, and surfactants. Anyone with a known allergy to polyethylene glycol should consult their physician prior to vaccine administration.

Updates for the week of December 28, 2020:

Category: COVID-19 Vaccine
Title: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Comment: The Moderna vaccine has a 94.1% efficacy, needs to be stored at -4°F and there are 20 million doses available by December 31. In contrast, the Pfizer vaccine has a 95% efficacy, needs to be stored at -94°F and there are 50 million doses available by December 31. There are three other vaccines which the FDA is currently working on. These vaccines include the following companies: Johnson and Johnson, AstraZeneca, and Novavax. All three are looking to be authorized by the FDA in expedited fashion in accordance with operation warp speed.

Category: COVID-19 Testing
Title: BinaxNOW COVID-19 Ag Card Home Test
Source: U.S. Food and Drug Administration
Synopsis: FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample. The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.

Comment: The FDA authorized Abbott Labs’ rapid COVID-19 test for at home use, although the doctors must prescribe the test for patients. This is the third at home test for COVID-19 which has been authorized by the FDA. Patients can buy the test for $25 in a drugstore and collect a sample with a nasal swab themselves and an app helps guide the testing process and provide results in about 15 minutes. Everyone 15 years or older or suspected of having COVID-19 by their healthcare provider and is within the first seven days of symptom onset are eligible for the test. It can also be used for children four years of age or older, though an adult needs to collect the sample. Abbot expects to deliver 3 million at home tests in the first quarter of 2021, with another 90 million in the second quarter. Again, this is not as accurate as a molecular PCR test. The authorization comes after the FDA cleared Ellume’s at home COVID-19. Ellume was authorized for use in anyone two years or older, either asymptomatic or symptomatic, and does not require a prescription.

Category: COVID-19 Variant
Title: COVID-19: New Coronavirus Variant is Identified in the UK
Source: British Medical Journal
Synopsis: VUI-202012/01 (the first “Variant Under Investigation” in December 2020) and is defined by a set of 17 changes or mutations. One of the most significant is an N501Y mutation in the spike protein that the virus uses to bind to the human ACE2 receptor. Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people.

Comment: This is the first variant under investigation as defined by a set of 17 mutations. The most significant mutation is in a spike proteins which binds to the human ACE2 receptor. In theory, this leads to the virus being more infectious with a greater propensity to spread among people. This was identified by the COVID-19 Genomic consortium which has sequenced 140,000 virus genomes from people infected with COVID-19 since April 2020. Thus far, this mutant infection now accounts for 20% of viruses sequenced in Northfalk, 10% in Essex, and 3% in Suffolk. It is important to note there is no evidence it has been imported from abroad and appears to have evolved in the United Kingdom. Mutations are common and many thousands have already arisen, the vast majority have no effect on the virus that can be useful as a barcode to monitor outbreaks. There is no evidence this strain causes more severe illness. The current vaccines should work against this strain.

Category: COVID-19 Vaccine
Title: Does the COVID Vaccine Pose Potential Side Effects for Dermal Filler Patients? A Dermatologist Weighs In
Source: New Beauty
Synopsis: Rachel Zhang, an FDA medical officer who is presenting the agency’s analysis of the Moderna data, reported that two people developed facial swelling after vaccination; both had a prior history of getting cosmetic injections of dermal fillers in their cheeks.” It was also reported that a third person had a possible post-vaccine reaction to dermal fillers in her lip area.

Comment: Both Pfizer and Moderna are reporting more allergic reactions than they previously anticipated. Many centers for vaccination are keeping EpiPen‘s available and having patients stay for 30 minutes instead of 15 minutes. There have been several reports of facial swelling in patients with filler and the treatment is a simple course of oral steroids and or oral antihistamines. The patient’s resolved there are swelling rapidly with this regimen. As more news develops regarding this potential reaction we will post more information.

Updates for the week of December 14, 2020:

Category: COVID-19 Vaccine
Title: FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

Comment: The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be. Two healthcare workers in the United Kingdom developed severe allergic signs and symptoms; however, they had a history of severe allergic reactions and both of them carried an EpiPen. At this time the FDA committee is not recommending this vaccine for anybody with a history of severe allergies.

Category: COVID-19 Prophylaxis
Title: Analysis of vitamin D level among asymptomatic and critically ill COVID-19 patients and its correlation with inflammatory markers
Source: Nature Scientific Reports
Synopsis: COVID-19 is characterized by marked variability in clinical severity. Vitamin D had recently been reviewed as one of the factors that may affect the severity in COVID-19. This study analyzed the vitamin D level in COVID-19 patients and its impact on the disease severity. Vitamin D level is markedly low in severe COVID-19 patients. Inflammatory response is high in vitamin D deficient COVID-19 patients. This all translates into increased mortality in vitamin D deficient COVID-19 patients. As per the flexible approach in the current COVID-19 pandemic authors recommend mass administration of vitamin D supplements to populations at risk for COVID-19.

Comment: This rigorous study published in Nature makes a compelling case for treating Vitamin D deficiency, which is quite common, to avoid severe COVID-19 infections. Plastic surgeons might be interested in this article and following future studies to determine whether recommending Vitamin D supplements for themselves and their patients may become prudent.

Category: COVID-19 Updates
Title: FDA Consumer Warning
Source: U.S. Food and Drug Administration
Synopsis: As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Rat’s Army for selling unapproved products with fraudulent COVID-19 claims. The company sells “VIRUS BIOSHIELD” with misleading claims that the product can mitigate, prevent, treat, diagnose or cure COVID-19 in people. Consumers concerned about COVID-19 should consult with their health care provider.

Comment: Virus Bioshield contains thymosin alpha pharmaceutical grade immune booster with anti-viral properties. Thymosin Alpha 1 (TA1) is a peptide, or small protein, produced naturally by the thymus gland. The thymus is where immune cells known as T cells mature and are released when prompted to do so by the TA1 peptide.

Category: COVID-19 Testing
Title: SARS CoV-2 Reference Panel
Source: U.S. Food and Drug Administration
Synopsis: On Dec. 2, the FDA updated the SARS CoV-2 reference panel comparative data on our website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The FDA provided the panel, composed of standardized samples, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their emergency use authorization (EUA).

Comment: The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested.

Category: COVID-19 Testing
Title: COVID-19 and Flu Combination Test for use with home-collected samples
Source: U.S. Food and Drug Administration
Synopsis: FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

Comment: This authorization for at home collection samples for COVID-19 and influenza A and B is a significant achievement by the FDA.

Category: COVID-19 Testing
Title: FDA Authorizes First Direct-to-Consumer COVID-19 Test System
Source: U.S. Food and Drug Administration
Synopsis: FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.

Comment: This kit can be purchased online or in local drug stores without a prescription. This is the first kit available for consumers to self-collect COVID-19 samples in their own home. This will help consumers decide the appropriateness of self-isolation or quarantine. They can communicate with their healthcare provider with more definitive evidence to aid in healthcare decisions.

Updates for the week of November 23, 2020:

Category: COVID-19 Updates
Title: FDA COVID-19 Updates
Source: U.S. Food and Drug Administration
Synopsis:

The FDA updated guidance on the use of COVID-19 convalescent plasma. This extends the treatment. Through the end of February 2021 patients may receive treatment with convalescent plasma and includes a new recommendation that convalescent plasma should not be collected from individuals who have received the COVID-19 vaccine.
The FDA published a new web page titled “A closer look at COVID-19 diagnostic testing.” This is a source for all healthcare providers and public health officials to examine COVID-19 tests, and includes information on both diagnostic and antibody testing for COVID-19.
To date there are now 223 molecular tests, 58 antibody tests, and 7 antigen tests.

Comment: Obviously the FDA believes in the use of convalescent plasma is to treat patients with COVID-19 in a hospital situation. They are continuing the allowance of this treatment through February 2021. The article written on “a closer look at COVID-19 diagnostic testing” is in plain language and is a good source for practitioners like us who make clinical decisions on testing for our patients and purchasing such equipment. The private sector continues to deliver unprecedented numbers of tests which the FDA has offered emergency use authorization.

Category: COVID-19 Vaccine
Title: Pfizer’s COVID-19 Vaccine Proves 90% Effective in Latest Trials
Source: Wall Street Journal
Synopsis: A coronavirus vaccine developed by Pfizer Inc. and partner BioNTech SE showed in an early analysis to be more than 90% effective in protecting people from COVID-19, a much-better-than-anticipated result that marks a milestone in the hunt for shots that can stop the pandemic.

Comment: Pfizer originally stated their COVID-19 vaccine had 90% efficacy. Shortly thereafter, Moderna released an analysis of its vaccine which revealed 95% efficacy. Within several days Pfizer changed their statement and stated their vaccine was 95% efficacious, similar to the Moderna vaccine. This was an interesting change of efficacy. Practically speaking, the Pfizer vaccine must be stored at -70°F requiring specialty storage facilities available only in hospitals and or universities. The Moderna vaccine can be stored at -20°F making it more user-friendly for distribution to clinics, outpatient facilities and or pharmacies.

Category: Category: COVID-19 Treatment
Title: The FDA Grants Emergency Approval to Eli Lilly’s Antibody Treatment
Source: New York Times
Synopsis: The Food and Drug Administration has granted emergency authorization of a COVID-19 treatment made by the American pharmaceutical company Eli Lilly. The treatment is approved for people 12 and older who have tested positive and are at risk of developing a severe form of COVID-19 or being hospitalized for the condition.

Comment: There are two antibody treatments currently promoted to treat COVID-19 infection. A polyclonal antibody treatment from Regeneron. However, Eli Lily has the first antibody treatment to be awarded emergency use authorization from the FDA. The clinical indications are limited for the Eli Lily antibody treatment known as bamlanivimab. In other words, you cannot receive this antibody treatment if you are already hospitalized because it may lead to worsening of the COVID-19 infection in patients who require supplemental oxygen and or ventilation. To make the matter more confusing Eli Lily states there is no benefit in reducing mortality from their antibody treatment. They do state it will reduce hospitalization and emergency room visits in the 28 days after receiving the intravenous therapy.

Category: Category: COVID-19 Testing
Title: FDA Authorizes The First At-Home Coronavirus Test
Source: New York Times
Synopsis: The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home.The test, developed by the California-based company Lucira Health, requires a prescription from a health care provider. People under the age of 14 also cannot perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less

Comment: The sensitivity of this test compares to other tests with a 94.1% sensitivity. It is a molecular ( PCR ) test. It will not be available until spring 2021.

Category: COVID-19 Vaccine
Title: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

Comment: There are currently two vaccines which are being released for the vaccination of COVID-19 infection. One is the vaccine from Pfizer who is working with BioNTech, a company from Europe. The other is the Moderna vaccine. Both companies are seeking emergency use authorization. A meeting to discuss the emergency use authorization of these vaccines is scheduled for December 10, 2020.

Category: Category: COVID-19 Treatment
Title: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Source: U.S. Food and Drug Administration
Synopsis: The FDA approved emergency use authorization for two antibody treatments to be used together during intravenous infusion. This is termed polyclonal antibody treatment. They include casirivimad and imdevimad. When administered together through intravenous infusion this drug combination known as Regeneron reduces COVID-19 related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Safety and efficacy continue to be evaluated. Regeneron is not indicated for patients who are hospitalized or who require oxygen therapy due to COVID-19 infection. Regeneron was given the emergency use authorization to be administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age or older and weighing at least 40 kg) with positive test results who are at high risk for progressing to severe COVID-19 infection. High-risk patients include those who are 65 years of age or older or who have certain chronic medical conditions.

Comment: Eli Lily was granted an emergency use authorization for intravenous antibody therapy. Now, the widely popularized polyclonal antibody therapy known as Regeneron has also been given emergency use authorization for treatment of COVID-19 infection. Regeneron consists of two antibodies known as casirivimad and imdevimab. These two “vimad” monoclonal antibodies attack the spike proteins of the coronavirus. By attacking the spike proteins on the coronavirus it greatly diminishes the entry of the virus into human cells. When used together they form a polyclonal antibody treatment known as Regeneron. It must be administered in a hospital setting.

Updates for the week of October 26, 2020:

Category: COVID-19 Transmission
Title: Lowering the transmission and spread of human coronavirus
Source: Journal of Medical Virology
Synopsis: Nasal rinses and mouthwashes, which directly impact the major sites of reception and transmission of human coronaviruses (HCoV), may provide an additional level of protection against the virus. Common over‐the‐counter nasal rinses and mouthwashes/gargles were tested for their ability to inactivate high concentrations of HCoV using contact times of 30 s, 1 min, and 2 min. Reductions in titers were measured by using the tissue culture infectious dose 50 (TCID50) assay. A 1% baby shampoo nasal rinse solution inactivated HCoV greater than 99.9% with a 2‐min contact time. Several over‐the‐counter mouthwash/gargle products including Listerine and Listerine‐like products were highly effective at inactivating infectious virus with greater than 99.9% even with a 30‐s contact time. In the current manuscript we have demonstrated that several commonly available healthcare products have significant virucidal properties with respect to HCoV.

Comment: This study adds to prior literature that has suggested the use of dilute betadine for gargles and nasal rinses. Dilute Betadine was also effective. Saline rinses with a Neti-Pot were ineffective.

Category: COVID-19 Patients
Title: The Worst Patient – A Physician with COVID-19
Source: JAMA Otolaryngology – Head & Neck Surgery
Synopsis: Physicians are accused of being the worst patients. This is a reflection of one surgeon’s battle with COVID-19, and the lessons learned from battling the virus, patient care, and being there for your family.

Comment: This physician started with an extreme state of denial. He almost died from COVID pneumonia. Interestingly, he received intravenous Remdesivir while taking oral hydroxychloroquine. He was discharged to home 11 days after being hospitalized. It eventually took him weeks to recover. However, during his initial denial he transmitted COVID-19 to his entire family. His story is honest, humble and exemplifies the fact that physicians are patients too. This is a must read for all of us.

Category: COVID-19 Treatment
Title: FDA Approves First Treatment for COVID-19
Source: U.S. Food and Drug Administration
Synopsis: FDA approved the antiviral drug Veklury (Remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Comment: Veklury better known as Remdesivir is the first FDA approved treatment for moderate to severe COVID-19 illness. 20% of patients who develop COVID-19 develop difficulty breathing and require hospital care. Remdesivir has been shown to decrease hospital stay by five days (from 17 days to 12 days). This drug is given intravenously and is confined to inpatient hospital care.

Category: COVID-19 Updates
Title: FDA COVID-19 Updates
Source: U.S. Food and Drug Administration
Summary: In a new “FDA Voices”, entitled the FDA’s Vaccines and Related Biological Products Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, Peter Marks, MD, PHD, highlights the value of transparency.

Comment: This update emphasizes the FDA’s continued push for transparency in developing the COVID-19 vaccine. In many nationwide polls, there is evidence that less than half of Americans indicate they would receive the COVID-19 vaccine. The push for transparency is the FDA saying they would like as many people to be vaccinated as possible.

Updates for the week of October 12, 2020:

Category: COVID-19 Updates
Title: Outpatient Plastic Surgery Is Safe During the Covid-19 Pandemic: Results of a July 2020 Los Angeles Survey and Literature Review
Source: Aesthetic Surgery Journal
Synopsis: This survey assessed the safety of plastic surgery during the pandemic by quantifying: 1) the preoperative prevalence of SARS-CoV-2; 2) the risk of postop COVID-19; 3) outcomes and precious resource utilization for such cases; and 4) the risks to office staff.

112 surgeons reported 5633 surgeries since resuming elective surgery. 103 (91.96%) of respondents obtained a SARS-CoV-2 PCR test on every preoperative patient. The preoperative PCR test was positive in 41/5881 (0.69%). Positive tests within two weeks occurred in 7/5380 (0.13%) of surgical patients, 3/8506 (0.04%) of injection patients, and 6/2519 (0.24%) of energy therapy patients. Nine offices reported at least one staff member who developed COVID-19. All cases were mild, with no hospitalizations or deaths.

Comment: This data demonstrates that plastic surgery can be safely performed during a COVID-19 surge by ABPS diplomates. This has profound impact for patients, plastic surgeons, and health policy regulators.

Category: COVID-19 Testing
Title: FDA COVID-19 Testing Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA released several important data compilation tables of the molecular PCR testing. This is comparative data of the different manufacturers and their corresponding molecular PCR tests. Using the limit of detection (LoD) value as the primary value to rate the tests. In other words, the lower the value of the LoD, the higher the sensitivity. For example the Abbott Molecular Company has a PCR test called the Abbott RealTime SARS-CoV-2 assay which has LoD of 5,400. This favorably compares to the Cepheid Company PCR test called the Xpert Xpress SARS-CoV-2 test which has an LoD of 5,400 as well. These two tests are distributed nationwide and are amongst the most frequently used tests on the market. The lowest LoD is 180 from PerkinElmer. The highest LoD is 600,000 from Boston Medical Center. Limit of detection matters. Assays with higher LoD will miss more infected patients, resulting in more false negatives. For each 10 fold increase in LoD there is an expected increase in the false negative rate by 13%. The highest LoD on the market will miss a majority of infected patients, with false negative rates as high as 70%. Therefore the choice of assay has meaningful clinical and epidemiological consequences.

Comments: It is definitely worthwhile to review this article and read table 1 and table 2. For example, if you’re thinking of buying an Abbott ID NOW machine for $4,500, you can compare it to other testing machines and the LoD with other machines currently on the market.

Category: COVID-19 Updates
Title: FDA Action and Ongoing COVID-19 Updates
Source: U.S. Food and Drug Administration
Synopsis: The FDA has issued the following updates:

FDA revised its Emergency Use Authorization (EUA) to reflect changes in the distribution and allocation of the antiviral drug Veklury (Remdesivir). More information about the revised EUA can be found here.
FDA has issued a warning letter to Kerri Rivera and her company KetoKerri, LLC, for the sale of unapproved and misbranded drugs related to the Coronavirus. Products “KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic”, “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS” make fraudulent claims to mitigate, prevent, treat, or cure COVID-19 in people.
FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19.

Comment: Beginning October 1, 2020 American hospitals can now purchase Veklury (Remdesivir) directly from the drugs distributor. The distributor is AmerisourceBergen. This is an antiviral drug which has emergency use authorization to treat hospitalized adult and pediatric patients with suspected or laboratory confirmed COVID-19. This drug was recently used to treat the President of the United States. Over the past five months the United States government has overseen the allocation and distribution of this drug due to its limited supply. The drug will now be more widely available by allowing the drug to be purchased directly from the distributor. The drug will now be more widely available by allowing the drug to be purchased directly from the distributor. Hospitals will pay no more than Gilead’s wholesale acquisition price which is $3,200, per treatment course. Patients do not pay directly for the drug because Medicare and private insurers are incorporating the overall treatment cost based on the patient’s diagnosis.

The FDA awarded Stanford University a $1.55 million contract to study the pathogenesis of an immune response to SARS-CoV-2 and other coronaviruses. Knowledge databases will be generated to inform medical countermeasures against these viruses. This information will be critical to any future COVID-19 response including any preparation needed for future outbreaks.

Category: COVID-19 Updates
Title: Preserving Elective Surgeries in the COVID-19 Pandemic and the Future
Source: JAMA
Synopsis: The practice of surgery has not been immune, with emergency declarations by many states to suspend elective procedures and office visits in mid-March. While only temporary, this abrupt cessation of surgery has had far-reaching implications that can inform future approaches in the context of both crisis and uncertainty.

Comment: This brief and thoughtful viewpoint article is very good. There has been a significant loss of revenue to United States hospitals. From March 1 to June 30, 2020 the estimated loss is $50 billion. Elective procedures are reimbursed at a higher level than Medicare. There is a process called “cost shifting” where elective surgery cases actually subsidize the loss of income secondary to the lower reimbursement of Medicare. In other words, 2/3 of the patients (Medicare) are subsidized by the 1/3 of the patients (elective surgery). Therefore, it is important to continue elective surgeries during this trying economic challenge.

Their recommendations are as follows:

Rapid and accurate PCR tests.
Guaranteeing availability of PPE for staff, students, and patients.
Adherence to preventive practices like masking, social distancing, and frequent handwashing.

Category: COVID-19 Vaccines
Title: FDA Updates on COVID-19 Vaccinations
Source: U.S. Food and Drug Administration
Synopsis: FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support issues of an emergency use authorization for investigational vaccines intended to prevent COVID-19. A new website launched at www.fda.gov/covid19vaccines to highlight new information as it becomes available. Testing updates now include 214 molecular tests, 52 antibody tests, and five antigen tests.

Comments: By having the FDA issue guidance with recommendations for vaccine sponsors it allows timely guidance to support the response efforts of the COVID-19 pandemic.

Updates for the week of September 28, 2020:

Category: COVID-19 Testing
Title: Assessing a novel, lab-free, point of care test for SARS-CoV-2 (“CovidNudge”): a diagnostic accuracy study
Source: Lancet
Synopsis: COVID testing appears to have a number of new options on the horizon. This paper looks at a UK-developed RT-PCR test, designed to be a lab-free, point of care system, called “COVIDNudge”. The nasal swab is placed directly into the portable unit, without the need for further reagents, making it easy for field use. This lab-on-a-chip system enables a comparison of a sample against both the WHO and CDC assays. In addition, the chip includes a control assay for human RNA, which eliminates “false negative” results by testing for inadequate swabbing. Testing indicates a sensitivity of 94.4% and a specificity 100%.

Comments: Not yet available in the USA, but has the European CE mark.

Category: COVID-19 Updates
Title: FDA Action and Ongoing COVID-19 Response
Source: U.S. Food and Drug Administration
Synopsis: The FDA has issued a round up updates, highlights include:

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
External Link Disclaimer, explains to consumers that there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family.
Content has been added to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.

Comment: There are currently no drugs or vaccines which are FDA approved and available to treat or prevent COVID-19. There are many fraudulent tests for COVID-19. Beware of products claiming to prevent or treat COVID-19, especially those which claim to be a “cure all” for many ailments.

Category: COVID-19 Immunity
Title: COVID-19 herd immunity: where are we?
Source: Nature Reviews Immunology
Synopsis: Herd immunity is a key concept for epidemic control. It states that only a proportion of a population needs to be immune (through overcoming natural infection or through vaccination) to an infectious agent for it to stop generating large outbreaks. A key question in the current COVID-19 pandemic is how and when herd immunity can be achieved and at what cost.

Comments: The safest way to achieve herd immunity for COVID-19 is through an effective vaccine. Deaths can be prevented by first vaccine targeting highly vulnerable populations which will have a significantly greater impact on reducing virus circulation than naturally acquired immunity. Moreover, since there are increasing numbers of reports of long-term complications even after mild COVID-19, vaccines are likely a safer option for individuals who are not classified at risk. Furthermore, 60% to 70% of the population will need to have antibodies in order to achieve herd immunity.

Category: COVID-19 Screening
Title: Comparison of Chest Ultrasound and Standard X-Ray Imaging in COVID-19 Patients
Source: Ultrasound International Open
Synopsis: A small study from Germany (n=24) looking at patients with confirmed COVID by PCR, who underwent both standard CXR and bedside chest ultrasound. Chest ultrasound performed better than CXR. In the symptomatic group (18/24), Chest ultrasound detected 94% (17/18), while CXR detected 11/18 (p<0.02). Ultrasound findings known as “pathologic B lines” were seen commonly, along with interstitial changes, focal pulmonary consolidation and small pleural effusions. Of note, the asymptomatic group (6/24) did not have visible changes with either CXR or chest ultrasound.

Comments: Bedside chest ultrasound is a rapid and potentially useful initial assessment tool for detecting peripheral lung pathology in COVID-19, and in this small study, performed better than CXR. This is not a common imaging modality in North America, but perhaps needs to be further utilized. Larger studies are required.

Updates for the week of September 14, 2020:

Category: COVID-19 Immune Response
Title: Humoral Immune Response to SARS CoV-2 in Iceland
Source: New England Journal of Medicine
Synopsis: Little is known about the duration of antibody response to COVID-19. This study looked at anti-COVID-19 antibodies in 30,576 persons in Iceland, and followed up with serial immunoglobulin assays up to 4 months after diagnosis. Of the 1,215 people who had recovered from COVID-19 and were tested, 91% were seropositive, and they remained seropositive for antibodies up to 4 months (duration of the study). Case fatality rate in this cohort was estimated at 0.3%, higher in older people, and those with comorbidities.

Comments: This study is much more optimistic about duration of antibody response to COVID-19 than prior reports from Spain. Also, in this cohort, only 56% of COVID-19 cases were picked up by PCR, while another 14% of cases occurred in non-tested quarantined individuals, showing the usefulness of appropriate quarantine measures. Concerningly, 30% of documented cases occurred in people outside quarantine and were not detected by PCR. These were cases with mild or little symptoms. This suggests the need for continued vigilance.

Category: COVID-19 Vaccines
Title: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
Source: U.S. Food and Drug Administration
Synopsis:The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.

Comments: The FDA has announced a public meeting of the vaccines and related biological products advisory committee to be held on October 22, 2020. Dr. Stephen Hahn said “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible ...”. The FDA will provide background material available to the public including the meeting agenda and committee roster. Again, this is a concerted effort to allow transparency during vaccine development.

The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines.
FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations.

Comments: The FDA is again proclaiming the transparency of its oversight on the promotion and development of vaccines for COVID-19. The FDA strongly believes vaccines will bring the pandemic under control.

Additionally, the FDA posted temporary guidelines directing drug and biological product manufacturers and their transition from operations impacted by the COVID-19 health emergency to a more normal manufacturing operating system.

Testing updates include 197 PCR molecular tests, 46 antibody tests, and 4 antigen tests.

Category: COVID-19 Testing
Title: Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be
Source: New York Times
Synopsis: Most of these people are not likely to be contagious, and identifying them may contribute to bottlenecks that prevent those who are contagious from being found in time. But researchers say the solution is not to test less, or to skip testing people without symptoms, as recently suggested by the Centers for Disease Control and Prevention.

Comments: This article is based upon the recommendations of Dr. Michael Mina who is an epidemiologist at the Harvard T.H. Chan School of Public Health. He contends a PCR test can be quantitative. Amplification cycles are needed to find virus in the specimen.

If there is a large viral load fewer amplification cycles are required; conversely, If there is a small viral load a greater number of amplification cycles will be needed to detect the virus. The number of amplification cycles to find COVID-19 virus is called the CYCLE THRESHOLD (C.T.). Currently, most testing sites set the limit at 40 and a few at 37. The problem is with the CYCLE THRESHOLD set do high even genetic fragments which are left over from an infection are causing the tests to be positive and these leftover fragments pose no risk. Many virologists agree that a CYCLE THRESHOLD above 35 is too sensitive. Dr. Mina recommends the CYCLE THRESHOLD be set at 30 or even less. Now a positive test would be worth acting upon. The CDC is currently examining using the CYCLE THRESHOLD measurement to make “policy decisions “. The CDC‘s calculations suggest it is extremely difficult to detect any live virus in a sample above a cycle threshold of 33. For example, in Massachusetts 90% of people who tested positive in July with a C.T. of 40 would have been deemed negative if the C.T. were 30. The number of people with positive results who are not infectious is concerning. The FDA noted people with an initial infection may have a low viral load and a test with less sensitivity would miss these infections; however, if the patient was tested 6 to 15 hours later the viral load would be high enough and their test would then be positive even with the C.T. set at 30. The real answer is developing a test which is fast, cheap, and readily available to frequently test everyone, even if the test is less sensitive. The four new antigen tests which are becoming available may be the solution. which are becoming available may be the solution. For example, there is a new antigen test which will read like a pregnancy test within five minutes. Furthermore, new data emphasize the need for more widespread use of these rapid tests even if they are less sensitive.

Updates for the week of August 24, 2020:

Category: COVID-19 Survey Results
Title: The Aesthetic Society COVID-19 Safety Task Force Survey Results
Source: The Aesthetic Society
Synopsis: The COVID-19 Safety Task Force has analyzed the results of the survey it sent out on July 29, 2020. This report highlights some key statistics from the survey.

Comments: These results of the survey reinforce The Society’s recommendations and our mission to put patient safety first.

Category: COVID-19 Testing
Title: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.

Comment: This is the first antigen test where results can be read directly from the testing card, similar to a pregnancy test. The results are available within 15 minutes after performing a nasal swab. Abbott plans to make 50 million tests available at the beginning of October. This will be called the BinaxNOW COVID-19 Ag Card. Antigen tests are very specific but less sensitive than molecular PCR tests. Negative results from an antigen test should be considered with the entire clinical picture of history and epidemiology; therefore, a negative antigen test may need to be confirmed with a molecular PCR test prior to treatment decision.

Category: COVID-19 Treatment
Title: FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

Comment: COVID-19 Convalescent Plasma or CCP is an unapproved biological product which has recently been authorized by the FDA for emergency use authorization (EUA) as a passive immune therapy for the treatment of hospitalized patients with COVID-19. There are four lines of evidence supporting the use of CCP for hospitalized patients with COVID-19:

History of convalescent plasma for respiratory coronavirus
Evidence of pre-clinical safety and efficacy in animal models
Published studies of the safety and efficacy of CCP
Data on safety and efficacy from the National Expanded Treatment Protocol (EAP) sponsored by the Mayo Clinic.

The most current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease.

Category: COVID-19 Vaccinations
Title: AMA Strongly urges FDA transparency in COVID-19 vaccine development
Source: American Medical Association
Synopsis: The American Medical Association wrote to the U.S. Food and Drug Administration (FDA) urging them to work more closely with the physician community starting now to develop a plan for further education and transparency surrounding COVID-19 vaccine candidates. We want physicians fully informed as the vaccine development process evolves. This is particularly important to address vaccine hesitancy by patients.

Comments: Halting the pandemic requires herd immunity. Herd immunity is achieved when 60 to 70% of the population is immune to the virus. According to two recent polls from Yahoo News/YouGov and NBC News/SurveyMonkey less than 50% of American adults say they plan to get a COVID-19 vaccine. This is of grave concern to the health community. A vaccination campaign emphasizing efficacy and safety with extreme transparency will be of utmost importance.

Updates for the week of August 17, 2020:

Date: August 17, 2020
Category: COVID-19 Testing & Updates
Title: FDA Updates
Source: U.S. Food and Drug Administration
Synopsis: The FDA has issued a round up updates, highlights include:

The third Emergency Use Authorization (EUA) for a COVID-19 antigen test. LumiraDX UK Ltd.’s LumiraDx SARS-CoV-2 Ag Test, and authorized the test for use in high and moderate complexity laboratories certified Under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
A frequently asked questions for consumers about UV lights and lamps was created. Consumers may be interested in purchasing ultraviolet-C (UVC) lamps to disinfect in the home or similar spaces.

Comments: There are now three antigen tests available. These have the ability for rapid diagnosis within 15 minutes.

The coronavirus will only be deactivated by direct exposure to UV radiation. UVC lamps sold for home utilization or of low dose and it may take longer exposure to a given surface area to inactivate the virus. UVC radiation is commonly used to disinfect air within air ducts. This is the safest way to use UVC radiation because direct exposure to this radiation can damage human skin and or eyes. There have been reports of skin and eye burns resulting from improper installation of UVC lamps in rooms that humans occupy. The risks of UVC radiation include the following:

Direct exposure of skin and eyes may cause injury.
Some UVC lamps generate ozone which can irritate the airway.
UVC radiation can degrade material such as plastics, polymers and dyed textile.
Some UVC lamps contain mercury which can be toxic even in small amounts and extreme caution is needed in cleaning a lamp that has broken and in disposing of the lamp.

Date: August 17, 2020
Category: COVID-19 Testing
Title: SalivaDirect, an RNA extraction-free SARS CoV-2 diagnostic test receives FDA EUA.
Source: U.S. Food and Drug Administration
Synopsis: The SalivaDirect test for COVID-19 is the first open-source PCR testing method that has been granted an EUA by the FDA. The saliva specimen can be collected in any sterile container, and doesn’t require any specialized swabs. Trained healthcare workers are not needed to collect the sample, specimen containers are widely available and frequent testing should be more readily accepted by patients, versus NP swabs. Additionally, the SalivaDirect lab protocol has been designed to work with any of several alternatives for reagents and PCR testing components, and does not require the usual nucleic acid extraction step. There are no proprietary portions of the process. Any CLIA approved laboratory can run the test, and will have much more flexibility in their supply chain, as they can substitute reagents, if needed.
Comments: This protocol has the potential to greatly reduce testing shortages. Correlation of clinical results with standard PCR methods has been very high, according to the developers at Yale University. For those interested, the detailed lab protocol can be viewed here.

Updates for the week of August 10, 2020:

Date: August 10, 2020
Category: COVID-19 Testing & Updates
Title: FDA Testing and Consumer Updates
Source: U.S. Food and Drug Administration
Synopsis: The FDA has issued a round up updates, highlights include:

Emergency Use Authorizations for molecular tests. Emergency use of the tests is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet requirements to perform high complexity tests:
- LumiraDx UK Ltd., for its LumiraDx SARS-CoV-2 RNA STAR, and
- Biomeme, Inc., for its Biomeme SARS-CoV-2 Real-Time RT-PCR Test.

A warning letter jointly with the Federal Trade Commission to one company for selling unapproved and misbranded COVID-19-related products. The company, Oxford Medical Instruments USA, Inc., sells salt inhaler products, including “OMI Salt Therapy Pipes,” with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19.

Comments: The FDA warning on salt inhaler pipes is appropriate. Meanwhile, the University of California San Francisco is researching an inhaler or nasal spray which prevents the COVID-19 virus from entering our cells. This could be important until a vaccine is created (see below).

Date: August 10, 2020
Category: COVID-19 Prophylaxis
Title: ‘AeroNabs’ Promise Powerful, Inhalable Protection Against COVID-19
Source: University of California, San Francisco
Synopsis: A team of researchers engineered a completely synthetic, production-ready molecule that straitjackets the crucial SARS-CoV-2 machinery that allows the virus to infect our cells. As reported in a new paper, now available on the preprint server bioRxiv, experiments using live virus show that the molecule is among the most potent SARS-CoV-2 antivirals yet discovered.
Comments: Early experiments using live virus show production ready molecules are among one of the most potent antivirals to be discovered. Used either by inhalation or nasal spray, these molecules have been termed ‘AreoNabs.’ The Company's goal is to make it available as an inexpensive and over the counter medication to prevent COVID-19 infection.

Updates for the week of August 3, 2020:

Date: August 3, 2020
Category: COVID-19 Testing
Title: New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools
Source: U.S. Food and Drug Administration
Synopsis: The FDA posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.
Comments: The two most important points of this FDA release are simplicity of the test and expediency of the test. If we can find a test that is simple, accurate, and gives results within minutes it will truly be revolutionary in the diagnosis and treatment of COVID-19.

Date: August 3, 2020
Category: COVID-19 Testing
Title: Coronavirus (COVID-19) Update: FDA Authorizes First Two Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
Source: U.S. Food and Drug Administration
Synopsis: The FDA authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Atellica IM COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.
Comments: At the present moment antibody tests are not clinically relevant for plastic surgeons. However, as the puzzle of antibody tests is being pieced together, the relevance of antibody tests are going to be increasingly more important. The more knowledge of antibody testing could prove extremely valuable.

Date: August 3, 2020
Category: Sanitizer Recall
Title: Hand Sanitizers: FDA Updates on Recalls Due to Dangerous, Potential Presence of Methanol (Wood Alcohol)
Source: U.S. Food and Drug Administration
Synopsis: FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.
Comments: Do not use any products on this list of hand sanitizers with potential methanol contamination, and continue checking this list often as it is being updated daily.

Date: August 3, 2020
Category: COVID-19 Symptoms
Title: Is It Allergies or COVID-19?
Source: WebMD
Synopsis: Spring allergy season has been especially challenging because of COVID-19, patients, and a lot of allergy sufferers, can have a hard time distinguishing between what is an allergy and what are symptoms of COVID-19.
Comments: It is evident that almost any of these symptoms could indicate COVID-19 infection. The key to differentiate allergy is the sign and symptom of itchiness. If this is coupled with a previous history of allergy and itchiness then allergy would be a more likely conclusion. Again, PCR testing is the key to diagnosis.

Updates for the week of July 27, 2020:

Date: July 27, 2020
Category: COVID-19 Screening
Title: Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
Source: New England Journal of Medicine
Synopsis: This is a non-human primate study on a vaccine candidate, mRNA-1273 (Moderna). This rhesus macaque study had two immunizations, at 0 and 4 weeks, followed by test exposure to COVID-19 at 8 weeks, via intranasal and intra-tracheal routes, to access the upper and lower airways. Two different dosing schemes of mRNA vaccine were used. Antibody levels (SARS-CoV-2 S-2P–specific antibody responses), virus neutralizing activity, and T cell responses were followed serologically. PCR tests and viral detectability in BAL were also followed.

Comments: S-specific (spike protein) antibody and neutralizing response were obtained in both dosing groups. By day two after viral challenge, virus was undetectable in nasal swabs in the high dose vaccine group. No lung inflammation was seen in the higher dose vaccination group, at post-mortem 14-15 days after viral challenge. Both vaccine groups obtained high level protection versus the unvaccinated control group. Viral replication after test challenge was suppressed by vaccine in this study. Duration of protection is as-yet unknown.

Date: July 27, 2020
Category: COVID-19 Vaccine
Title: Increased Risk of COVID-19 Among Users of Proton Pump Inhibitors
Source: American Journal of Gastroenterology
Synopsis: Proton pump inhibitors (PPIs) increase the risk of enteric infections which is likely related to PPI-induced hypochlorhydria. This study found evidence of an independent, dose-response relationship between anti-secretory medications and COVID-19 positivity. Individuals taking PPIs twice daily have higher odds for reporting a positive test when compared to those using lower-dose PPIs up to once daily, and those taking the less potent H2RAs are not at increased risk.

Comments: The association between PPI use and COVID-19 needs further testing.

Date: July 27, 2020
Category: COVID-19 Testing
Title: FDA COVID-19 Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA has released updates on testing.

Reissue of the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing.
Approval of an abbreviated new drug application, or generic, for heparin sodium. The FDA continues to work to help patients suffering from COVID-19 by reviewing and approving generic medicines, such as anti-coagulants, used in the prevention and treatment of blood clotting.
Issued emergency use authorizations (EUAs) to two companies for serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. The tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The companies that were each issued an EUA are:

Xiamen Biotime Biotechnology Co., Ltd., for its BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test, and Access Bio, Inc., for its CareStart COVID-19 IgM/IgG.

Comments:

The FDA has authorized emergency use authorization (EUA) for an existing RT-PCR test for ASYMPTOMATIC patients and to allow POOLED testing on these patients. This may allow earlier detection for patients with COVID-19 infection.
By approving heparin sodium the FDA is acknowledging the important use of anticoagulants in the treatment of blood clotting disorders which arise in COVID-19 patients.
The FDA has approved emergency use authorization (EUA) for two new antibody tests.

Updates for the week of July 27, 2020:

Comments: The association between PPI use and COVID-19 needs further testing.

Date: July 27, 2020
Category: COVID-19 Testing
Title: FDA COVID-19 Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA has released updates on testing.

Reissue of the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing.
Approval of an abbreviated new drug application, or generic, for heparin sodium. The FDA continues to work to help patients suffering from COVID-19 by reviewing and approving generic medicines, such as anti-coagulants, used in the prevention and treatment of blood clotting.
Issued emergency use authorizations (EUAs) to two companies for serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. The tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The companies that were each issued an EUA are:

Xiamen Biotime Biotechnology Co., Ltd., for its BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test, and Access Bio, Inc., for its CareStart COVID-19 IgM/IgG.

Comments:

The FDA has authorized emergency use authorization (EUA) for an existing RT-PCR test for ASYMPTOMATIC patients and to allow POOLED testing on these patients. This may allow earlier detection for patients with COVID-19 infection.
By approving heparin sodium the FDA is acknowledging the important use of anticoagulants in the treatment of blood clotting disorders which arise in COVID-19 patients.
The FDA has approved emergency use authorization (EUA) for two new antibody tests.

Updates for the week of July 20, 2020:

Date: July 20, 2020
Category: COVID-19 Testing & Resources
Title: FDA COVID-19 Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA has released updates on testing and resources. Highlights include:

FDA created a new website section about COVID-19 for people with cancer and health care professionals.
The FDA updated its Frequently Asked Questions (FAQs) on Testing for SARS-CoV-2.
To date, the FDA has currently authorized 187 tests under EUAs; these include 154 molecular tests, 31 antibody tests, and 2 antigen tests.

Comments: The FDA is expediting oncology product development. Patients with cancer and any associated immunosuppression remain a top priority.

Date: July 20, 2020
Category: COVID-19 Testing & Research
Title: COVID-19 Updates of Note
Source: Web MD
Synopsis:

Pfizer signed a 1.95 billion contract with the U.S. government to deliver hundreds of millions of doses of coronavirus vaccine with a delivery goal of December 2020.
The United States has now reported more than 4 million confirmed cases of the coronavirus, nearly doubling the second highest count of 2.2 million cases in Brazil. According to Johns Hopkins university.
As emerging evidence points to airborne transmission, some studies found .2 air-conditioning as a potential cause of spreading the coronavirus. Recommendations include bringing in more air from the outdoors by opening windows and doors regularly to let fresh air in and using fans to disperse the fresh air.
A recent study from The American Society for Microbiology recommends decontaminating N95 masks using microwave technology. Researchers filled a glass container with 60 mL of water and secured mesh over the top of it with a rubber band. N95 masks were placed on the mesh and microwaved for three minutes effectively killing all of the virus.
The CDC recently refined its risk category for COVID-19, stating that obesity was as big a risk factor for COVID-19 as having a suppressed immune system or chronic lung or kidney disease. The agency also lowered the bar for where the risk starts and ends from a BMI of 40 to a BMI of 30.

Comments: 40% of Americans have a BMI over 30.

Updates for the week of July 13, 2020:

Date: July 13, 2020
Category: COVID-19 Testing
Title: Predictive Value of Sudden Olfactory Loss in the Diagnosis of COVID-19
Source: PubMed
Synopsis: Recent reports suggest that sudden smell loss might be a symptom of SARS-CoV-2 infection. The aim of this study was to investigate the frequency of olfactory loss in an outpatient population who presented to a coronavirus testing center during a 2-week period and to evaluate the diagnostic value of the symptom “sudden smell loss” for screening procedures.

Considering the high frequency of smell loss in non-hospitalized COVID-19 patients, acute olfactory impairment should be recognized as an early symptom of the disease and should be tested for on a regular basis. In contrast to other acute viral smell impairment, COVID-19-associated smell loss seems to be only rarely accompanied by a severely blocked nose.

Comments: If official smell kits are unavailable, consider alternatives like scratch and sniff stickers.

Date: July 13, 2020
Category: COVID-19 Testing & Consumer Warnings
Title: FDA COVID-19 Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA has released a potpourri of essential items from testing to consumer warnings. Highlights include:

Posting of an updated Coronavirus Treatment Acceleration Program (CTAP) webpage.
Warning letters to two firms for selling unapproved products in the United States with false or misleading claims that their products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
Addition of dexamethasone sodium phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 public health emergency

Comments: The CTAP dashboard provides a snapshot of development of potential COVID-19 therapeutics. To date 510+ drug development programs are in the planning stages and 230+ trials have been reviewed by the FDA. There are two COVID-19 treatments currently authorized for emergency use. There are zero treatments currently approved by the FDA for use in COVID-19.

Updates for the week of July 6, 2020:

Date: July 6, 2020
Category: COVID-19 Testing & Consumer Warnings
Title: FDA COVID-19 Update
Source: U.S. Food and Drug Administration
Synopsis: The FDA has released a potpourri of essential items from testing to consumer warnings. Highlights include:

A letter to clinical laboratory staff and health care providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.
Updated the Molecular Diagnostic templates on FDA.gov to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples.
A consumer warning to health care professionals that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.
Warning letters to five companies for selling fraudulent COVID-19 products.
FDA has currently authorized 166 tests under EUAs; these include 138 molecular tests, 26 antibody tests, and 2 antigen tests.

Comments: Methanol, known as wood alcohol, can be toxic when absorbed through the skin and life-threatening if ingested.

Date: July 6, 2020
Category: COVID-19 Testing
Title: FDA Issued Emergency Use Authorization for Point of Care Antigen Test
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens. This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.

Comments: Antigen tests can provide results in minutes. They may not detect all active infections based upon their mechanism of action. They are very specific for COVID-19, however they are not as sensitive as molecular PCR tests. Therefore, positive results from antigen tests are highly accurate but there’s a higher chance of false negatives, so negative results do not rule out infection. Negative results from antigen testing may need to be confirmed with a PCR test prior to making a treatment decision.

Date: July 6, 2020
Category: COVID-19 Viral Relapse
Title: Clinical recurrences of COVID-19 symptoms after recovery: viral relapse, reinfection or inflammatory rebound?
Source: Journal of Infection
Synopsis: The authors present a small case series of 11 patients with confirmed COVID-19 who then experienced a second confirmed COVID-19 episode following their initial clinical recovery. Four of the patients were healthcare workers, 7 were older adults. All episodes were confirmed by PCR testing. The second episodes happened between 23 and 58 days after the first onset of symptoms.

The test results are detailed in the report. Three theories – viral relapse, reinfection and inflammatory rebound are discussed. At this point, it is too early to tell which theory is most likely.

Comments: However, this report raises the concerns that:

COVID-19 relapses can occur in a subset of patients;
COVID-19 patients may not truly be “fully recovered” for a prolonged period of time after the apparent resolution of clinical symptoms. This may impact scheduling of elective surgeries.

Further investigations are required.

Updates for the week of June 29, 2020:

Date: June 29, 2020
Category: COVID-19 Testing
Title: Serology (antibody) tests approved by the FDA
Source: Federal Drug Administration
Synopsis: The following serology tests have received FDA emergency use authorization (EUA) for use in COVID-19 assessment, as of 6/27/2020. Sensitivity, Specificity, PPV and NPV are listed on the site. Of note, all are currently classified as “high” or “moderate” complexity tests, and thus require appropriate CLIA lab authorization.

Abbott Alinity i SARS-CoV-2 IgG
Abbott Architect SARS-CoV-2 IgG
Autobio Anti-SARS-CoV-2 Rapid Test
Babson Diagnostics aC19G1- IgG
Bio-Rad Platelia SARS-CoV-2 Total Ab
Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
Cellex qSARS-CoV-2 IgG/IgM Rapid Test
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG
Emory Medical Laboratories SARS-CoV-2 RBD IgG test
EUROIMMUN SARS-COV-2 ELISA (IgG)
Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette
Healgen COVID-19 IgG/IgM Rapid Test Cassette
InBios SCoV-2 Detect IgG ELISA
Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test
Ortho-Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG test
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator
Roche Elecsys Anti-SARS-CoV-2
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)
Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay
Wadsworth New York SARS-CoV Microsphere Immunoassay for Antibody Detection

Date: June 29, 2020
Category: COVID-19 Testing
Title: Independent Evaluations of COVID-19 Serological Tests
Source: Federal Drug Administration
Synopsis: Independent labs have assessed the quality of a number of serologic (antibody) tests for COVID-19. Sensitivity, Specificity, NPV and PPV are listed on the site. The ones listed have been found to have less than optimal performance, and should not be used clinically. They have been removed from the FDA EUA, have been withdrawn by the manufacturer, or were never authorized in the first place. If you have serologic tests in your facility, please check that you are not using these particular ones.

Abacus Pharma International SARS-CoV-2 IgM/IgG AB Antibody Rapid Test
Accudiagnostics Covid-19 IgM/IgG Test Kit
Atlas-Link (Beijing) Nova COVID-19 IgG/IgM Antibody Rapid Test
Aurora Biomed Inc COVID-19 IgG/IgM Rapid Test
Biomedomics COVID-19 IgM-IgG Rapid Test kit
ChemBio DPP COVID-19 IgM/IgG System
Chemtron Biotech, Inc. Rapid COVID-19 IgM/IgG Antibody Screen Test
GP Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Phamatech COVID19 RAPID TEST
SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo
Shanghai Fosun Long March Medical Science Co., Ltd. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
TESTSEALABS SARS-COV-2-IgG/IgM Test Cassette
Tianjin Beroni Biotechnology Co., Ltd. SARS-COV-2 IgG/IgM Antibody Detection Kit
W.H.P.M, Inc. Covisure Covid-19 IgM/IgG Rapid Test
Zhongshan Bio-Tech Co LTD SARS-CoV-2 IgM-IgG (GICA)

Date: June 29, 2020
Category: COVID-19 Testing
Title: Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
Source: Federal Drug Administration
Synopsis: Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs to combat COVID-19. The FDA took a step forward in providing more tests to patients more quickly and making that process even easier for developers by posting template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.
Comments: This clever strategy could be a better option for the COVID-19 testing of our employees. It would be worthwhile for our offices to reach out to local labs to see if and when they are offering this service.

Date: June 29, 2020
Category: COVID-19 Testing
Title: A Dire Warning From COVID-19 Test Providers
Source: The Atlantic
Synopsis: The American testing supply chain is stretched to the limit, and the ongoing outbreak in the South and West could overwhelm it, according to epidemiologists and testing-company executives. While the country’s laboratories have added tremendous capacity in the past few months—the U.S. now tests about 550,000 people each day, a fivefold increase from early April—demand for viral tests is again outpacing supply.
Comments: This article is worth reading as it lucidly lays out where the US stands with regard to COVID-19 testing. The facts would suggest that our offices should be cognizant of, and prepared, for possible shortages of testing supplies.

Date: June 29, 2020
Category: COVID-19 Testing
Title: Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
Source: BMJ
Synopsis: This is a meta-analysis of 40 studies and 29,842 tests of the three different methods of serology (antibody) tests for covid-19: ELISA, LFIA and CLIA.

ELISA = enzyme-linked immune-absorbent assays
LFIA = lateral flow immunoassays
CLIA = chemiluminescent immunoassays

Their results show a significant difference between the types of tests.
The pooled results for sensitivity of the tests measuring IgG or IgM antibodies to COVID-19 were: ELISA = 84.3%, LFIA = 66.0%, and CLIA = 97.8%
Comments: Sadly, the poorly-performing LFIA method is the style of test that would have been easiest for point of care testing, as it is typically arranged like a pregnancy-test style cartridge, to which a drop of blood and a reagent are added. The study authors recommend avoiding lateral flow-based serology tests for COVID-19 entirely.

Updates for the week of June 22, 2020:

Date: June 22, 2020
Category: COVID-19 Testing
Title: Important Information About the Use of Serological (Antibody) Tests for COVID-19: Letter to Health Care Providers
Source: Federal Drug Administration
Synopsis: FDA recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.
FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection. While the FDA remains open to receiving submissions for these tests for such uses, based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.

Comments: The FDA recommends health care providers:

Continue to use serological (antibody) tests, as appropriate, and be aware of their limitations.
Do not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed.
Be aware that not all marketed serological tests have been evaluated by the FDA. The FDA’s authorized tests, including serological tests, are listed on the Emergency Use Authorization (EUA) page.Tests being offered under a policy outlined in the FDA’s COVID-19 Diagnostic Policy Guidance are listed on our FAQ page. Such tests have not been reviewed by the FDA, unless an EUA has also been submitted and reviewed by FDA.

Most experts feel that there are at least four valid uses for serology tests.

Patients with a COVID-19 style illness who have been PCR negative.
Large scale population surveys to determine the degree of community exposure.
Screening tests for convalescent plasma donors.
Determining exposure for frontline medical personnel.

Date: June 22, 2020
Category: COVID-19 Testing
Title: Certain COVID-19 Serology/Antibody Tests Should Not Be Used: FDA Letter to Clinical Laboratory Staff and Health Care Providers
Source: Federal Drug Administration
Synopsis: The FDA is issuing this communication to ensure that laboratories and health care providers who may still have within their stock tests on FDA's “removed” test list, or have used such tests, are aware that these tests may have demonstrated poor clinical performance or lack adequate information to support clinical performance. Results for antibody tests that have been evaluated through the Department of Health and Human Services (HHS) National Institutes of Health (NIH), National Cancer Institute (NCI) independent evaluation program may be found on FDA’s Independent Evaluations of COVID-19 Serological Tests webpage. The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

Comments: The FDA recommends laboratories and health care providers:

Stop using the antibody tests listed on FDA’s “removed” test list.
Evaluate, given the patient’s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-authorized test.
Remove from your stock any remaining tests that are listed on FDA’s “removed” test list.
Report any issues with using COVID-19 tests to the FDA.

The FDA's efforts to rapidly make available resources to combat COVID-19 with the early release of antibody tests under the Emergency Use Authorization (EUA) are now undergoing more closely evaluated validation. As of June 24, 2020, 50 more antibody tests have been removed from the EUA.
These tests should no longer be distributed for COVID-19 according to the FDA As of June 24, 2020

ACCOBiotech SDN.BHD	ACCO COVID-19 IgM/IgG TEST	Removed - Should Not Be Distributed
Anhui Deepblue Medical Technology Co., Ltd.	COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Artron BioResearch Inc./ Artron Laboratories Inc.	COVID-19 IgM/IgG Antibody Test	Removed - Should Not Be Distributed*
Atlas Link (Beijing)Technology Co., Ltd	NovaTest: One Step COVID-19 IgG/IgM rapid test	Removed - Should Not Be Distributed
Audacia Bioscience	CMC-19D SARS-CoV2 (COVID-19) Rapid Antibody Test	Removed - Should Not Be Distributed
Aurora Biomed Inc.	COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)	Removed - Should Not Be Distributed
Beijing Decombio Biotechnology Co., Ltd.	Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)	Removed - Should Not Be Distributed
Beroni Group	SARS-CoV-2 IgG/IgM Antibody Detection Kit	Removed - Should Not Be Distributed
BestNovo (Jiangsu) Medical Technology Co., Ltd.	BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Biobase Biodustry (Shandong) Co., Ltd.	SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
BioMedomics, Inc.	COVID-19 IgM-IgG rapid test	Removed - Should Not Be Distributed*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody	Removed - Should Not Be Distributed
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody	Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody	Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody	Removed - Should Not Be Distributed
Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.)	Rapid 2019-nCoV IgG/IgM Combo Test Card	Removed - Should Not Be Distributed
Calbiotech, Inc.	ErbaLisa® COVID-19 IgG	Removed - Should Not Be Distributed
Changchun Wancheng Bio-Electron Co., Ltd.	COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)	Removed - Should Not Be Distributed
Chembio Diagnostic Systems, Inc.	DPP COVID-19 IgM/IgG System	Removed - Should Not Be Distributed
Diazyme Laboratories, Inc.	Diazyme SARS-CoV-2 Antibody Rapid Test	Removed - Should Not Be Distributed*
Fosun Pharma USA Inc.	Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit	Removed - Should Not Be Distributed*
Genlantis Diagnostics, Inc.	CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test	Removed - Should Not Be Distributed*
Getein Biotech Inc.	One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)	Removed - Should Not Be Distributed
Guangdong Hecin Scientific, Inc.	SARS-CoV-2 IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Hangzhou Clongene Biotech Co., Ltd.	COMBRA COVID-19 IgM/IgG Rapid Test Cassette	Removed - Should Not Be Distributed
Hangzhou Testsea Biotechnology Co., Ltd.	One Step SARS-CoV2(COVID-19) IgG/IgM Test	Removed - Should Not Be Distributed*
Hunan RunKun Pharmaceutical Co., Ltd.	SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
IMMY, Inc.	clarus SARS-CoV-2 Total Antibody EIA	Removed - Should Not Be Distributed*
Innovation Biotech (Beijing) Co., Ltd.	SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method)	Removed - Should Not Be Distributed
Jiangsu Eubo Biotechnology Co., Ltd.	EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)	Removed - Should Not Be Distributed
JOYSBIO (Tianjin) Biotechnology Co., Ltd.	COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Lifeassay	Test-it COVID-19 IgM/IgG Lateral Flow Assay	Removed - Should Not Be Distributed
Nantong Egens Biotechnology Co., Ltd	EGENS COVID-19 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
Phamatech	COVID19 IgG / IgM Rapid Test	Removed - Should Not Be Distributed*
Promedical	COVID-19 Rapid Test	Removed - Should Not Be Distributed
Saladax Biomedical	COVID-19 IgG/IgM Rapid Antibody Test	Removed - Should Not Be Distributed*
SD Biosensor	STANDARD Q COVID-19 IgM/IgG Duo	Removed - Should Not Be Distributed
Shanghai Eugene Biotech Co., Ltd.	SARS-CoV2 (COVID-19) IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Shenzen Landwind Medical Co., Ltd.	COVID-19 IgG/IgM Rapid Test	Removed - Should Not Be Distributed*
Sure Bio-tech	API Covid-Rapid IgM/IgG Antibody Test Kit	Removed - Should Not Be Distributed
Suzhou Kangheshun Medical Technology Co., Ltd	SARS-CoV-2 IgG/IgM Rapid Test Cassette	Removed - Should Not Be Distributed
Tianjin Beroni Biotechnology Co. Ltd	SARS-CoV-2 IgG/IgM Antibody Detection Kit	Removed - Should Not Be Distributed
VITA Testing	COVID-19 IgM/IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
W.H.P.M., Inc.	COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
W.H.P.M., Inc.	COVISURE™ COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Zhongshan Bio-Tech Co Ltd.	SARS-CoV-2 IgM/IgG (GICA)	Removed - Should Not Be Distributed*
Zhuhai Encode Medical Engineering Co., Ltd	Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device	Removed - Should Not Be Distributed*

Updates for the week of June 15, 2020:

Date: June 15, 2020
Category: COVID-19 Testing
COVID-19 and Its Implications for Thrombosis and Anticoagulation
Source: Blood (June 4, 2020)
Synopsis: The initial coagulopathy of COVID-19 presents with prominent elevation of D-dimer and fibrin/fibrinogen-degradation products, whereas abnormalities in prothrombin time, partial thromboplastin time, and platelet counts are relatively uncommon in initial presentations. Coagulation test screening, including the measurement of D-dimer and fibrinogen levels, is suggested for suspected COVID-19 patients.

D-dimer has been shown to be an indicator of mortality in COVID-19. All confirmed or suspected COVID-19 patients admitted to the hospital should be treated with pharmacologic VTE prophylaxis, given the high inflammatory state, unless there are specific contraindications.

Comments: Consider pre-operative screening for coagulation abnormalities (with D-dimer and fibrin/fibrin-degradation products) and possible hematology consult in patients with prior COVID-19 or positive antibody tests, even if they seem fully recovered, especially for abdominoplasty and other procedures like body lifts that have an inherent higher potential risk of DVT and PE.

Date: June 15, 2020
Category: COVID-19 Testing
Factors Associated With Surgical Mortality and Complications Among Patients With and Without Coronavirus Disease 2019 (COVID-19) in Italy
Source: JAMA Surgery
Summary: This cohort study of 41 surgical patients with COVID-19 and 82 tightly matched control patients without COVID-19 found highly significant differences in rates of early mortality (19.5% vs 2.5%) and post-operative complications, esp. pneumonia, respiratory failure and thrombotic complications in patients with COVID-19. Patients with COVID-19 were approximately 13 x more likely to have complication than matched non-COVID-19 controls. The patients were orthopedic, vascular, neurosurgery, general surgery and thoracic surgery, recruited from a single medical center in Italy, over a 36 day period. The authors concluded that, whenever possible, surgery should be postponed in patients with COVID-19 because it is an additional surgical risk factor that outweighs traditional ones.

Comments: The study population in this analysis tended to be elderly and only 10% were ASA class I - II. Approximately 50% of the cases were orthopedic. While it rightfully stresses the importance of COVID-19 screening and surgery postponement in the COVID-19 positive patient, the data set is not representative of the typical younger & healthier aesthetic surgery patient.

Updates for the week of June 8, 2020:

Date: June 8, 2020
Category: Elective Surgery
Elective Surgery during SARS- CoV-2 / Covid-19 pandemic
Source: PRS-Global Open
Summary: The authors performed a literature review to synthesize new recommendations for pre-operative COVID-19 testing for plastic surgery patients.
In the authors’ countries (Mexico & Colombia), serologic testing is widely used at the point of patient care. Their suggested pre-op test protocol includes:

Screening for signs and symptoms of COVID
Serology testing (IgM and IgG) at the first consultation appointment, with repeat test 7 days later.
RT-PCR swab for COVID-19
Pre-op CXR prior to surgery
Avoidance of surgeries greater than 3 hours in length
Avoidance of patients with any comorbidities associated with COVID-19 (obesity, diabetes, age>60, smoking, etc.)

Notes: The COVID-19 Task Force of the Aesthetic Society felt it was worthwhile to comment on this paper. In our opinion, we feel this approach should not be applied verbatim in the United States.

While serologic testing for antibodies can be quick (<15 minutes), there are currently no point-of-care serology tests that are CLIA waived in the USA. As of this writing, all FDA-approved tests for IgG or IgM detection require a moderate or high complexity CLIA certificate. Most surgeon’s offices and surgery suites are not appropriately certified for such testing. The TF is aware of a number of non-FDA approved antibody tests on the market, and does not recommend them for general use by the membership.

There are four systems for RT-PCR antigen testing which are CLIA-waived, and these could potentially be suitable for point of care use in the USA. These tests detect viral genetic material from a nasal swab or sputum sample.

The TF recognizes that some publications have recommended serial testing for COVID-19 in higher prevalence areas, in order to reduce the percentage of false-negatives. The optimal timing and selection criteria of these tests have not yet been determined. Standard PA & lateral chest X-ray is not recommended by the CDC for COVID diagnosis.

At the present time, there are opinions but no valid data on appropriate patient selection with respect to comorbidities, or acceptable lengths of surgical times in a COVID-negative patient.

Updates for the week of June 1, 2020:

Date: June 5, 2020
Category: COVID-19 Testing
Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study
Source: The Lancet
Synopsis: Multicenter cohort study, 1,128 patients who had surgery between Jan 1 and March 31, 2020, at 235 hospitals in 24 countries and were found to have COVID-19 at some point in their perioperative course. Main study variable examined was 30-day mortality.

Major findings: In this heterogeneous group, the 30-day mortality overall was 23.8% and pulmonary complications occurred in 51.2%

30-day mortality was associated with male sex, age>70 years, ASA grade 3-5 vs. 1-2, malignant versus benign diagnosis, emergency vs. elective procedure and major vs. minor surgery.

Comments: While this patient group doesn't reflect our typical plastic surgery patient group, there are some relevant findings:

30-day mortality in ASA 1-2 with perioperative COVID: 11.6%, and 39% pulmonary complications (pneumonia, ARDS, unexpected ventilation)
Presence of 0 comorbidities: 7% 30 day mortality
Presence of 1 comorbidity: 17% 30 day mortality (includes, smoking, asthma, COPD, diabetes, hypertension, etc.)
Take home message: Even though this data is not directly relevant to plastic surgery patients, it reinforces and strengthens prior data on the need for screening for COVID-19 in the pre-operative patient in general, and need to reschedule non-essential procedures in a COVID-19 positive patient.

Updates for the week of May 25, 2020:

Date: May 25, 2020
Category: COVID-19 Testing COVID-19 Patient Test Request Email Source: The Aesthetic Society Synopsis: These email templates can be used by surgeons to prompt patients to order COVID-19 tests.

Date: May 25, 2020
Category: COVID-19 Testing
False Negatives on RT-PCR testing
Source: Annals of Internal Medicine
Synopsis: Tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on reverse transcriptase polymerase chain reaction (RT-PCR) are being used to “rule out” infection among high-risk persons, such as exposed inpatients and health care workers. It is critical to understand how the predictive value of the test varies with time from exposure and symptom onset to avoid being falsely reassured by negative test results.

Comments:

Predictive value of the PCR varies with time from exposure and symptom onset.
The probability of false-negative results is 100% on day 1-2 after exposure, falling to 38% when symptoms begin roughly 4 days later and then to 20% at 3 days after symptom onset. (See top illustration.)
Best time to test with PCR: 6-10 days after exposure = 1-5 days after symptom onset.
RT-PCR provides little diagnostic value immediately after COVID exposure (pre-symptomatic). If clinical suspicion is high, do not rule out infection on basis of RT-PCR alone.

Date: May 25, 2020
Category: COVID-19 Testing
Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
Source: U.S. Food and Drug Administration
Synopsis: The FDA has identified 28 companies as NOT FDA approved and NOT on the "notification list of tests being offered under the "Policy for Coronavirus Disease - 2019 Tests During the Public Health Emergency.

Comments::

All listed tests are serology tests.
FDA expects that the tests on this list will not be distributed unless and until an Emergency Response Authorization (EUA) is issued for the test, and FDA may take additional actions as appropriate.
Manufacturer Tests

Updates for the week of May 18, 2020:

Date: May 21, 2020
Category: Staff
What to do when a medical provider or staff member is exposed to COVID-19?
Source: COVID-19 Safety Task Force
Synopsis: Due to the fluidity of this situation, the Task Force has created an ancillary document that solely addresses what to do if a staff member or medical provider is potentially exposed to COVID-19. Please note that these recommendations would not supersede local governing Health Department regulations.

Date: May 18, 2020
Category: PPE and peri orbital surgical considerations
Considerations for ophthalmic surgery during the COVID-19 pandemic
Source: Asia –Pacific Journal of Ophthalmology
Synopsis: The Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory coronavirus-2, was first reported in December 2019. The World Health Organization declared COVID-19 a pandemic on March 11, 2020 and as of April 17, 2020, 210 countries are affected with >2,000,000 infected and 140,000 deaths. The estimated case fatality rate is around 6.7%. We need to step up our infection control measures immediately or else it may be too late to contain or control the spread of COVID-19. In case of local outbreaks, the risk of infection to healthcare workers and patients is high. Ophthalmic practice carries some unique risks and therefore high vigilance and special precautions are needed. We share our protocols and experiences in the prevention of infection in the current COVID-19 outbreak and the previous severe acute respiratory syndrome epidemic in Hong Kong. We also endeavor to answer the key frequently asked questions in areas of the coronaviruses, COVID-19, disease transmission, personal protection, mask selection, and special measures in ophthalmic practices. COVID-19 is highly infectious and could be life-threatening. Using our protocol and measures, we have achieved zero infection in our ophthalmic practices in Hong Kong and China. Preventing spread of COVID-19 is possible and achievable.

Updates for the week of May 11, 2020:

Date: May 13, 2020
Category: PPE
Headaches and the N95 face-mask amongst healthcare providers
Source: Acta Neurologica Scandinavica, 2006
Synopsis: During the 2003 severe acute respiratory distress syndrome (SARS) epidemic, many healthcare workers were mandated to wear N95 respirators. Many of these individuals developed headaches. The attached link offers a survey study from Singapore looking at the incidence of headaches in healthcare workers related to the N95 respirator. Further, this study examined predisposing factors for those who were affected. There were a total of 212 total respondents, with 79 (37%) reported face-mask-associated headaches. They found that those with preexisting headaches and those who wore the mask for >4 hours continuously were significantly more prone to developing headaches related to the N95 respirator.

Comments:Headaches from the N95 respirators is a real phenomenon. This is especially true for those who already suffer from headaches and with prolonged use.

Consider this data if you or your staff plan to wear the N95 when you operate or for long office hours
Attempt to take breaks from the N95 respirator throughout the day if safe and practical
Consider this data when deciding to schedule surgeries with long OR times and/or joint procedures

Date: May 13, 2020
Category: COVID-19 Testing
Quidel Receive Emergency Authorization for Rapid Antigen COVID-19 Diagnostic Assay
Source: Quidel Corporation
Synopsis: Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

Comments: Remember that emergency authorization does not mean the device has been formally approved by the FDA.

Not formally approved.
Requires CLIA Clearance at this time.
Potential point of care (in office) test.
Results in 15 minutes.
At the present moment patients must meet CDC criteria for COVID-19 infection.
deally we’d prefer to have this as a point of care test in our office/surgery centers to screen patients before procedures/surgeries.

Date: May 13, 2020
Category: COVID-19 Testing
Interpreting Diagnostic Tests for SARS-CoV-2
Source: Journal of the American Medical Association
Synopsis: The pandemic of coronavirus disease 2019 (COVID-19) continues to affect much of the world. Knowledge of diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is still evolving, and a clear understanding of the nature of the tests and interpretation of their findings is important. This Viewpoint describes how to interpret 2 types of diagnostic tests commonly in use for SARS-CoV-2 infections—reverse transcriptase–polymerase chain reaction (RT-PCR) and IgM and IgG enzyme-linked immunosorbent assay (ELISA)—and how the results may vary over time

Comments:

The most reliable tests are RT-PCR. These include nasopharyngeal swabs and more recently Saliva tests
Clear recommendations on "return to work" for Positively infected Health Care Workers. At least 3 days (72 hours) have passed since recovery defined as resolution of fever without the use of fever-reducing medications and improvement in respiratory symptoms (e.g., cough, shortness of breath); and, at least 10 days have passed since symptoms first appeared.
The virus has been detected in 57% of stool of infected patients, suggesting that there is a fecal-oral transmission in addition to aerosolized spread.
Antibody test results are still in evolution for effective use for individuals. They continue to be helpful for epidemiological data.
RT-PCR tests are the current gold standard for diagnosis of COVID-19. These include: nasopharyngeal swabs, mid-turbinate level swabs, anterior nasal swabs and more recently, saliva tests.

Date: May 13, 2020
Category: COVID-19 Testing
COVID-19 Digest Issue 3
Source: San Mateo County Department of Health
Synopsis: COVID-19 Serology Testing: COVID-19 serological assays are intended to detect antibodies against SARS-CoV2 in blood samples. It may take at least 1 week or longer, following onset of symptoms, for antibodies against SARS-CoV-2 to be detectable. Antibody responses to COVID-19 are not completely understood at this time, which currently limits their clinical utility. Please note that none of the serological assays, even those granted FDA Emergency Use Authorization (EUA) status, are approved for diagnosing cases of COVID-19. Therefore, serology should NOT be used for decisions relating to patient management or care. PCR remains the test of choice for laboratory diagnosis of COVID-19.

Comments: As of May 6, 2020, twelve (12) serologic assays have been granted EUA status by the FDA. The FDA has also posted information on the test performance of these serological assays.

Date: May 13, 2020
Category: General COVID-19 Knowledge
Hematological findings and complications of COVID-19
Source: American Journal of Hematology, April 2020
Summary: COVID-19 is a systemic infection with significant changes in the hemostatic system, not just the pulmonary system. Lymphopenia is common, and is a prognostic factor of poor outcome. Blood hypercoagulability is common. Inflammatory indices, such as LDH, CRP, IL-6 help to identify cases with worse prognosis. Elevated D-dimer levels are common, and are prognostic of both poor outcome and VTE occurrence. Other coagulation abnormalities, including thrombocytopenia and DIC, can be life-threatening.

Comments:

Even ambulatory COVID-19 patients should be considered for VTE prophylaxis.
The exact duration of the hypercoagulable/hyperinflammatory state in survivors is not yet known.
As more new plastic surgery patients will inevitably report a past personal history of a COVID-19 infection, surgeons need to be aware of a possible risk for VTE and might consider a hematologic consultation.
Consider a hematology consult pre-op in patients with prior COVID-19 and discuss with a hematologist whether additional lab studies would be beneficial: LDH, CRP, IL-6, D-dimer.