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.

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

Register for free to listen to this article
Listen with Speechify
0:00
8:00
Share

ABOVE: © ISTOCK.COM, HUMONIA

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 ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!
Already a member? Login Here

Related Topics

Meet the Author

  • Diana is a freelance science journalist who covers the life sciences, health, and academic life. She’s a regular contributor to The Scientist and her work has appeared in several other publications, including Scientific American, Knowable, and Quanta. Diana was a former intern at The Scientist and she holds a master’s degree in neuroscience from McGill University. She’s currently based in Berlin, Germany.

    View Full Profile
Share
Illustration of a developing fetus surrounded by a clear fluid with a subtle yellow tinge, representing amniotic fluid.
January 2026

What Is the Amniotic Fluid Composed of?

The liquid world of fetal development provides a rich source of nutrition and protection tailored to meet the needs of the growing fetus.

View this Issue
Human-Relevant In Vitro Models Enable Predictive Drug Discovery

Advancing Drug Discovery with Complex Human In Vitro Models

Stemcell Technologies
Redefining Immunology Through Advanced Technologies

Redefining Immunology Through Advanced Technologies

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Beckman Coulter Logo
Conceptual multicolored vector image of cancer research, depicting various biomedical approaches to cancer therapy

Maximizing Cancer Research Model Systems

bioxcell

Products

Sino Biological Logo

Sino Biological Expands Research Reagent Portfolio to Support Global Nipah Virus Vaccine and Diagnostic Development

Beckman Coulter

Beckman Coulter Life Sciences Partners with Automata to Accelerate AI-Ready Laboratory Automation

Refeyn logo

Refeyn named in the Sunday Times 100 Tech list of the UK’s fastest-growing technology companies

Parse Logo

Parse Biosciences and Graph Therapeutics Partner to Build Large Functional Immune Perturbation Atlas