FDA removes several antibody tests–doc says antibody tests here are accurate

On Thursday, May 21, the U.S. Food and Drug Administration said they have removed a number of antibody tests from those approved as being able to be offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.  Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.

Antibody tests are not used to diagnose COVID-19 as an active virus, but to tell if somebody already had COVID-19.

The FDA release says it expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request.

Dr. Scott Miscovich with Premier Medical Group, which does testing around the state, says the antibody tests being used in Hawaii–by his medical group and others–are quite accurate.  He said the antibody tests that require only a pinprick drop of blood are not as reliable as the ones being used on Hawaii Island, which requires a blood draw by a phlebotomist, and being sent to either Diagnostic Labs or Clinical Labs for analysis.

He also talked about the standard COVID-19 tests, and said that COVID-19 PCR tests being used in the state and on the island are generally better than 90% accurate.  The one exception is the Abbott Laboratories ID Now test, the test touted as able to return results to tell if somebody has an active COVID-19 case within 15 minutes.   On May 15, the FDA issued a warning that the tests may not be accurate, a claim disputed by Abbott Labs.  On the Big Island, Kona Community Hospital and Hilo Medical Center each have one of the Abbott Labs ID Now test machine.

Elena Cabatu, Public Information Officer for Hilo Medical Center, said in an email “We received the Abbott ID Now analyzer from the Department of Health at the end of April.  At the same time, we received a supply of 22 test kits.  Eleven of the kits were needed to perform an initial quality control (QC) procedure for the analyzer.  We have not received any further kits since the initial supply.   Due to the low availability of testing kits and the low number of positive patients, we are still in the process of validating the equipment and have not used the Abbott ID Now to perform COVID-19 testing.  Currently all COVID-19 tests are being sent to Clinical Labs of Hawaii for processing in Oahu or the mainland.”      Judy Donovan, Regional Director Marketing & Strategic Planning for Kona Community Hospital, said they are in close contact with State Department of Health about the Abbott tests, and that Clinical Labs processes the COVID tests at Kona Community Hospital.  KCH is not a public testing site, as is Hilo Medical Center, so the demand at Kona Hospital is much lower.

Tags: ,