(RxWiki News) The US Food and Drug Administration (FDA) has released a "removed" test list that includes certain COVID-19 antibody tests.
The tests were primarily included on this list for one of two reasons: They had effectiveness issues that the manufacturer could not address, or the manufacturer did not submit an Emergency Use Authorization request for them.
Other tests found on this list might have been voluntarily removed by the manufacturer.
Serological tests, also called antibody tests, detect antibodies to SARS-CoV-2. This helps identify those who have had COVID-19 before.
Antibody testing cannot be used for diagnosis of infection. This is because antibodies are part of the body's immune response to exposure and not the virus itself, according to the FDA.
The problem with faulty or unapproved COVID-19 tests? If the test gives a wrong result, such as a false positive, the person is told they have an immune response to SARS-CoV-2 when, in fact, they don't.
Although it is not yet clear whether the presence of antibodies means someone is immune to the virus, a false positive may result in a person not taking the necessary precautions against virus exposure.
Furthermore, this individual may get infected later but not seek testing, potentially increasing the spread of the disease.
The opposite may also occur — a false negative. This means a person is told they have not been exposed when they actually have. This may lead to further unnecessary diagnostic evaluations.
Currently, there are 53 tests on the FDA’s “removed” test list.
Although these tests were no longer being distributed, labs and doctors' offices may still have them in stock. The FDA recommended that the antibody tests on this list no longer be used.
Health care providers will determine whether patients who have used these tests need to be retested with an FDA-authorized test, the agency said.
Health care providers and consumers are strongly advised to report any issues with COVID-19 tests to the FDA via MedWatch, the FDA’s medical product safety reporting program.
The FDA said it will continue to update this “removed” test list.