SARS-COV-2: The Different Assays Validated By The FDA

SARS-COV-2: The Different Assays Validated By The FDA

As the world begins to see progress in virus prevention efforts, such as the home-stay instructions and social distancing policies, the current concerns revolve around the spread of the coronavirus, once the businesses resume their operations.

Antibody tests, also known as serological tests, may play a part in filtering out the affected- and recovered individuals. The outcomes of these tests will help determine who has been affected and who has developed antibodies that can protect against potential infections.

Outcomes can also help warn people who are willing to donate blood that may be used to make convalescent plasma, an investigational substance for use in those who are critically suffering from COVID-19.

In view of the active discussion on serological tests accessible on the market and their role in the nation’s response efforts, we would like to include more information on our thoughts on these tests and our approach to make correct and effective serological tests readily accessible, while also shielding individuals from tests sold with inaccurate or unsubstantiated statements.

FDA approach to expanding access to serology tests

To date, FDA has already released four E.U.A.s for serological tests, and it is expected that this number will continue to rise in the coming weeks.  The FDA urges developers to apply E.U.A. proposals for their experiments, as the E.U.A. would provide laboratories and suppliers with confirmation that the FDA has approved the application. The Food and Drug Administration is working around the clock to review E.U.A. applications quickly and intend to take action to ensure that the process is as streamlined and effective as possible.

Flexibility with serological testing ensures that labs and health care professionals have early access to these tests, recognizing that they have not been checked or accepted (or “approved”) by the FDA. These tests can not be used to diagnose or remove active SARS-CoV-2 infections (Stephen M. & MD, 2020).

FDA encouraging the researchers

The FDA released a guideline stating that it does not plan to object when developers market serological testing or they use their tests without a previous FDA examination where:

1) The tests are checked by the developer to assess that they are correct and reliable

2) The notice of the developer’s validation is sent to the FDA.

3) The tests are correctly labeled, namely that they are not to be used as the sole basis for diagnosis.

The bottom line is that the FDA also needs studies to be checked even under our updated research strategy. However, the E.U.A. system or the N.I.H. assessment encourages greater trust in the results of the studies (Stephen M. & MD, 2020).

Why is validation data needed?

All clinical studies should be verified prior to use, and this assumption is laid out in the policy of 16 March. The regular flexibility, independent of the FDA is also established. The approval of antibody tests are restricted in their clinical applications but they do require all researchers to confirm their experiments before providing them for limited clinical use.

In order to reduce the amount of false-positive findings, serological studies must be well developed to explicitly recognize antibodies to SARS-CoV-2 and must not “cross-react” or have positive results when detecting antibodies to other respiratory viruses.

Assays validated by the Food and Drug Administration (FDA)

The FDA, the U.S. Department, and The Department of Health and Human Services shall safeguard public health by ensuring the purity, efficacy, and safety of human and veterinary medicines, vaccines, and other biological materials for human use and medical devices. The Department is also responsible for the protection and security of the nation’s food supplies, cosmetics, dietary supplements, products that release electrical radiation, and the enforcement of tobacco products (McKinney, 2020).

Currently, Assure  COVID-19 IgG / IgM Rapid Test System is currently the only FDA approved COVID-19 POC Serology Test and is only accessible on prescription. The FDA. proceeds to partner with test developers to improve access to COVID-19 testing (Stephen M. & MD, 2020).

Assure COVID-19 IgG/IgM Rapid Test Device

The Assure COVID-19 IgG / IgM Rapid Test Device is a fast chromatographic lateral flow device. Immunoassay is intended for qualitative identification and separation of IgM and IgG antibodies. The Assure COVID-19 IgG / IgM Rapid Test System is designed for use as a help for the discovery of persons with an adaptive immune reaction to SARS-CoV-2, with a recent indication or pre-infection. At this time, it is not clear how long the antibodies survive after infection and whether the antibodies persist. The presence of antibodies confers defense immunity. The Assure COVID-19 IgG / IgM Rapid Evaluation Unit Acute SARS-CoV-2 infection should not be diagnosed. The use of this test for all approved specimen forms is restricted to clinically accredited laboratories. Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, which satisfies the criteria of conduct for low to high difficulty checks. This experiment is also approved for the use of fingersticks of whole blood specimens only at the point of treatment (P.O.C.), i.e., in health care environments working under the CLIA Certificate of Waiver, Certificate of Waiver Compliance, or Accreditation Certificate. The findings are for the identification of antibodies to SARS-CoV-2. SARS-CoV-2 antibodies against IgG and IgM. They are usually detectable in the blood several days after the original diagnosis, but the period of the infection can be longer. Antibodies present post-infection are not well characterized. Individuals may have a measurable virus present for several weeks after seroconversion. Laboratories within the United States and its dependencies are expected to report any positive findings to the relevant public health authorities.

The sensitivity of the Assure COVID-19 IgG / IgM Rapid Test System early after the disease is not known. Negative findings do not eliminate acute SARS-CoV-2 infection. If the intense infection is suspected, direct testing of SARS-CoV-2 is expected (FDA Gov, 2020).


FDA Gov. (2020, 22 September). Assure COVID-19 IgG/IgM Rapid Test Device. U.S. Food & Drug Administration. https://www.fda.gov/media/139792/download#:~:text=The%20Assure%20COVID%2D19%20IgG,EDTA)%20and%20fingerstick%20whole%20blood.

McKinney, J. (2020, 23 September). Coronavirus (COVID-19) Update: FDA. Authorizes First Point-of-Care Antibody Test for COVID-19. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19#:~:text=The%20Assure%20COVID%2D19%20IgG%2FIgM%20Rapid%20Test%20Device%20is,access%20to%20COVID%2D19%20testing.

Stephen, M., & M.D., H. (2020, 18 April). Food and Drug Administration. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts

Leave a Reply

Your email address will not be published. Required fields are marked *