Why the Accuracy of SARS-CoV-2 Antibody Tests Varies So Much

The FDA cracks down on test makers as independent evaluations of their products’ performance show a need for improvement.

| 8 min read
antibody test coronavirus pandemic covid-19 sars-cov-2 serology igg igm immunity

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Due to increasing demand from both researchers and policymakers, the number of antibody tests for SARS-CoV-2, the virus that causes COVID-19, has skyrocketed in recent weeks. According to a list kept by the nonprofit Foundation for Innovative New Diagnostics (FIND), more than 200 of these products, which are also known as serologic tests, are either now available or in development. Many of the test manufacturers are based in China, but there are also companies in a number of other countries, including South Korea, Germany, the US, and the UK.

Only 12 have received emergency use authorization (EUA) from the US Food and Drug Administration (FDA), which gives companies permission to deploy a product without providing the same amount of supportive evidence as required in the typical approval process. In March, the FDA announced that, to expedite availability, companies could market these tests in the US without ...

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Meet the Author

  • Diana Kwon

    Diana is a freelance science journalist who covers the life sciences, health, and academic life.
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