COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

• March 1, 2022: FDA Roundup including several safety communications
• February 25, 2022: FDA updates sotrovimab Emergency Use Authorization
• February 25, 2022: FDA Roundup including updates to testing information on FDA's website
• February 24, 2022: FDA authorizes revisions to Evusheld dosing
• February 24, 2022: HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base - Also see the updated FDA page: Executive Order 14017 on America’s Supply Chains
• February 23, 2022: Center for Drug Evaluation and Research Office of Pharmaceutical Quality 2021 Annual Report (PDF)

Bookmark www.fda.gov/coronavirus for the latest.

Do not use certain Celltrion DiaTrust COVID-19 tests

FDA issued a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging (see image). The test has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. (March 1, 2022)

Do not use SD Biosensor STANDARD Q COVID-19 Ag Home tests

FDA issued a safety communication warning people not to use the SD Biosensor STANDARD Q COVID-19 Ag Home Test. This test is packaged in a white and magenta box (see image) and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.  (March 1, 2022)

Do not use certain ACON Flowflex COVID-19 tests

FDA issued a safety communication warning people not to use the ACON Laboratories “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” This test is packaged in a dark blue box (see image) and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. (March 1, 2022)

Larger images are available on each page linked above.

FDA updates sotrovimab EUA

FDA is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently omicron and the omicron subvariants.

On February 23, 2022, FDA revised the EUA for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the EUA (PDF).  

FDA authorizes revisions to Evusheld dosing

On February 24, 2022, FDA revised the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose. Updated materials (PDFs) include: 

• Fact sheet for health care providers
• Fact sheet for patients, parents, and caregivers
• Frequently Asked Questions on the EUA for Evusheld

EUA revocation

FDA revoked the following EUA:

• February 24, 2022: BinaxNOW COVID-19 Ag Card 2 Home Test (Abbott Diagnostics Scarborough, Inc.) (PDF) - FDA understands no product was distributed under the EUA. Abbott indicated that authorization of the BinaxNOW COVID-19 Ag Card 2 Home Test is no longer required, in consideration of Abbott’s product available under another EUA issued to Abbott. 

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. 

SARS-CoV-2 viral mutations: Impact on COVID-19 tests

Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.  

In vitro diagnostic (test) EUAs

As of March 1, 2022, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 850 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics   

Find a COVID-19 vaccine or booster near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.  

Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.  

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.