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 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: 

  1. Rapid and accurate PCR tests.
  2. Guaranteeing availability of PPE for staff, students, and patients.
  3. 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.


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:

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:

  1. History of convalescent plasma for respiratory coronavirus
  2. Evidence of pre-clinical safety and efficacy in animal models
  3. Published studies of the safety and efficacy of CCP
  4. 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:
  • 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:

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 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:

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:

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:

  1. COVID-19 relapses can occur in a subset of patients;
  2. 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.

  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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