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Navigating the Wild West of COVID-19 antibody tests

Health Economics & Policy Research

The expectation that widespread COVID-19 antibody testing will be a cornerstone for reopening society has prompted a speedy, hands-off regulatory approach. But reports of poor performance by marketed tests suggest moving too quickly could result in individual and public health decisions that are based on unreliable results.

Dodging that bullet will require centralized resources, including broad access to the large numbers of patient samples needed to stringently validate the assays.

Tests that measure antibodies against the virus, known as serological tests, identify who has already been exposed and theoretically become immune.

Unlike molecular diagnostics that measure viral load, serological tests can’t be used to diagnose COVID-19 or determine whether people are at risk of infecting others or advancing to severe disease (see “Limits of Detection for the New Coronavirus”).

Instead, the assays are being positioned as a way to identify people who can safely return to work, especially in front-line healthcare settings; determine how and where COVID-19 is spreading, which could guide resource allocation decisions; and identify potential donors of convalescent sera.

FDA’s March 16th guidance on COVID-19 diagnostics opened the runway for serological tests to launch in the U.S. without FDA review under certain conditions. Such tests had already been made available by Chinese, Korean, Singaporean and European regulators weeks before.

“That’s really the impetus for why you’re seeing a flood of these tests coming into the market,” said Troy Hopps, point-of-care diagnostic leader at Becton Dickinson and Co. (NYSE:BDX), which co-launched a rapid serology test with BioMedomics Inc. on March 31.

FDA’s rationale for not requiring regulatory review is that the tests can’t be used to diagnose disease, are less complex than molecular diagnostics, and are needed as soon as possible.

“All the tools they would normally apply to qualifying and proving assays, they don’t have those tools available at the moment, there is no time,” said Andrew Levin, CEO and CSO of Kephera Diagnostics LLC.

Yet the risks posed by insufficiently sensitive and specific serological tests are arguably as serious as those posed by faulty diagnostics. In particular, false positives could lead people to resume normal activities while they are still vulnerable to COVID-19.