Unproven tests. Inaccurate results. Public health labs worry ‘bad data’ could taint US recovery from coronavirus crisis.
April 6, 2020 / Ken Alltucker and Kevin McCoy, USA TODAY
Companies are lining up to market an emerging type of blood test to detect whether a person has ever had the novel coronavirus. These antibody tests could be critical to reopening the U.S., informing public health and state officials on how and when Americans can resume everyday activities.
Some lab experts warn relaxed rules by the Food and Drug Administration allow unproven and potentially unreliable tests on the market. Companies marketing 90 antibody tests have notified the federal agency of plans to offer tests that gauge whether a person’s ever been infected with SARS-CoV-2, the virus that causes COVID-19.
The FDA will review the antibody tests in light of accuracy concerns raised by the Association of Public Health Laboratories, but the tests remain on the market.
Officials with the APHL acknowledged accurate and reliable antibody tests are an important tool in the nation’s pandemic response, but the wave of unproven tests sold through doctors’ offices or elsewhere might do more harm than good.
