Antibody Tests as a Wellness Screening Tool?

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We’ve started to see some testing companies advertising antibody tests as a potential employee screening tool to detect infected asymptomatic people.  These tests claim detection of IgM antibodies can be used to find “those in early stages of infection” and that these tests can be completed in less than 20 minutes for rapid onsite diagnosis.

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It’s important to recognize that antibody development occurs later in infection and this type of serological testing isn’t recognized by the FDA as a diagnostic test.  In mid-April FDA specifically stated:

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“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. When we become aware of these issues, we have and will continue to take appropriate action against firms making or distributing unvalidated tests or those making false claims, such as issuing Warning Letters requesting that companies stop their unlawful promotion and detaining and refusing fraudulent test kits at the border.”

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Developing accurate and rapid point-of-use diagnostic testing will help employers, clinicians, and public health officials identify and isolate help asymptomatic carriers of COVID-19 and limit the risk of transmission.  Many companies are attempting to develop this kind of diagnostic test and these tests will need to be both sensitive and specific to minimize the number of false positives and false negatives associated with widescale testing.  This will also likely require people to be tested on a fairly frequent basis since their exposure status can change quickly; especially as society beings to “reopen” in the coming weeks and months.

 

If you or your company is approached and encouraged to consider workplace testing for COVID-19, reach out to TAG to help independently evaluate the risks and benefits of testing programs and technologies.