Updates from the COVID-19 Safety Task Force

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 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.

  1. Patients with a COVID-19 style illness who have been PCR negative. 
  2. Large scale population surveys to determine the degree of community exposure. 
  3. Screening tests for convalescent plasma donors. 
  4. 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:

  1. Screening for signs and symptoms of COVID
  2. Serology testing (IgM and IgG) at the first consultation appointment, with repeat test 7 days later.
  3. RT-PCR swab for COVID-19
  4. Pre-op CXR prior to surgery
  5. Avoidance of surgeries greater than 3 hours in length
  6. 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.
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