FDA alerts staff of potential for false-positives with certain kits
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Sept. 17, the FDA issued a Letter to Health Care Providers to alert clinical laboratory staff and health care providers about the potential for false-positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. The Letter to Health Care Providers includes important information about Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits, including details on potential false-positive results, recommendations for clinical laboratory staff and health care providers, actions the FDA is taking, and instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits.
- On Sept. 16, the FDA revised the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab, administered together, is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus — only after exposure to the virus. Bamlanivimab and etesevimab, administered together, should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19. FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated if you are eligible. Learn more about FDA-approved or -authorized COVID-19 vaccines.
- On Sept. 15, the FDA issued revised guidance, Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency.
- On Sept. 14, the FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility. To date, a total of eight batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.
- Testing updates:
- As of today, 410 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 288 molecular tests and sample collection devices, 88 antibody and other immune response tests, and 34 antigen tests. There are 62 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.
- The FDA has authorized 15 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 636 revisions to EUA authorizations.
Related Information
- COVID-19 Vaccines: fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
- Coronavirus Disease 2019 (COVID-19): fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
