As many states prepare to slowly reopen the economy, the widespread manufacturing, distribution, and use of antibody tests have recently undergone heightened scrutiny by the FDA. The initial FDA guidelines and standards regarding the manufacturing and distribution of antibody tests were very low. Essentially, the only initial requirement for companies to sell and distribute antibody tests was for such tests to be “internally validated.” After discovering a high percentage of inaccurate tests, the FDA recently decided that manufacturers must meet heightened standards and requirements if they wish to keep their product on the market. The FDA will continue to work closely with companies who are unable to meet the heightened standard in order to remove such tests from the market.
According to the CDC, antibody blood tests check a person’s blood for antibodies to determine whether a person has been previously infected by the virus. A positive antibody test may reveal (1) a previous infection, (2) possible immunity, (3) whether any additional Covid-19 diagnostic tests are necessary, and (4) whether a person may be asymptomatic. In addition to the tests being inaccurate, there are serious questions concerning whether a positive antibody test means that a person is immune to the virus. This, of course, is the million-dollar question, especially for those who are on the verge of reentering the workplace.
While a positive antibody test might mean that a person has been exposed to the virus, health experts are still unsure about whether a positive test means that a person has built up any sort of meaningful immunity. Stephen Hahn, the FDA commissioner, when addressing the affect a positive antibody test might have on workplace reintegration, stated, “whether this is the ticket for someone to go back to work, my opinion on that would be no.” In other words, Hahn has stated that both employers and employees cannot completely rely on the outcome of an antibody test to determine whether it is safe to “resume as normal.”
This is not to say, however, that antibody tests will not eventually be a useful and effective tool for determining COVID-19 immunity in the workplace. The medical research surrounding COVID-19 is very fluid, with new findings and contradicting evidence being published on a daily basis. As the medical research continues to come into focus, the use of antibody tests in the workplace could very well prove to be an additional tool for employers and employees to consider. Thinking creatively about how antibody tests could practically play out in the workplace over the next few months, and even years, may be an important piece to your businesses strategy and plan to return to a state of normalcy.