Update May 4:
Serological (antibody) testing should “not be used as the sole basis to diagnose or exclude SARS-CoV-2 infections or to inform infection status,” the Texas Medical Association COVID-19 Task Force said in a statement.
Serology tests also should not be used to determine whether a patient is immune to SARS-CoV-2, the statement says.
“If a laboratory initially uses antibody testing for diagnostic purposes, follow-up testing using a molecular viral test should be performed,” the statement said. “Negative results from antibody testing do not rule out SARS-CoV-2 infections, particularly for those individuals who have been exposed to the virus and are still within the estimated incubation period.”
COVID-19 cases continue to spread in Texas and nationwide, although health officials have said mitigation efforts such as stay-at-home orders and social distancing are showing positive results.
One of the biggest questions that remains from health care professionals and the general public has to do with testing: Which tests are available and accurate, which are safe, and who should get them and when?
To help clear up confusion, Stephen M. Hahn, MD, commissioner of the Food and Drug Administration, published a statement Saturday on serological test validation and education efforts.
“To date, we have already issued four EUAs (emergency use authorizations) for serological tests, and we expect that number to grow in the coming weeks,” the statement said. “We are working around the clock to review EUA submissions quickly and we continue to take steps to ensure the process is as streamlined as possible.”
The statement acknowledges that FDA provided “regulatory flexibility” for serological tests to provide laboratories and health care workers early access to tests “with the understanding that the FDA had not reviewed or authorized (or ‘approved’) them.” These tests should not be used for diagnosing or excluding active SARS-CoV-2 infection, the statement said.
To provide clarity about which tests have been approved, FDA has posted on its website the early-access tests that have not been authorized.
“However, some test developers have misused the serology test kit notification list to falsely claim their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19,” the statement said.
In addition to taking action against firms making or distributing these claims, FDA is “sharing educational materials with state governments, hospital systems, payors, and health care professional associations to ensure they understand the potential for false-positive results in tests that have not yet been reviewed by FDA, and can make educated decisions when considering purchasing, insuring and using these tests,” Dr. Hahn said.
The statement also explains how serological tests work, which validation data are needed, and concerns and education for frontline workers and states.
In addition, the TMA COVID-19 Task Force created a “Frequently Asked Questions” (FAQ) to help you understand how to test patients safely and effectively.
The FAQ can be found on TMA’s COVID-19 Resource Center, which is updated regularly with the latest news, resources, and government guidance on the coronavirus outbreak.