FDA Clears Rapid At-Home Covid-19 Test

Scanning electron microscope image showing SARS-CoV-2 viruses, in yellow. (NIAID, NIH)

Update, 27 Dec. 2021: FDA’s list of of emergency use authorizations for Covid-19 antigen tests now has an entry for the Roche antigen detection test, under the name of its manufacturer SD Biosensor Inc. in Republic of Korea.

27 Dec. 2021. The Food and Drug Administration granted an emergency authorization to a quick diagnostic test for SARS-CoV-2 viruses, conducted at home. The global medical products company Roche says FDA cleared the test on Friday for non-prescription, retail sales, but the agency’s list of emergency use authorizations for Covid-19 antigen tests, as of 27 Dec., does not include the Roche product.

Roche, based in Basel, Switzerland, says its Covid-19 At-Home Test uses nasal swabs, performed by the patient or an adult for children, returning results in 20 to 30 minutes. The test, says Roche, detects nucleocapsid antigen proteins in nasal swab samples indicating the presence of SARS-CoV-2 virus. Nucleocapsid, or N proteins, are basic building blocks of coronaviruses. The company says its test uses a lateral flow or test-strip mechanism to indicate the presence or absence of SARS-CoV-2.

Roche says it assessed the Covid-19 At-Home Test in clinical trials with 138 individuals who provided 128 samples, including specimens with the now-dominant omicron variant. The results, says Roche, show the test has a true-positive sensitivity of 95 percent and a true-negative specificity of 100 percent. The company notes that rapid antigen tests are somewhat less sensitive than molecular tests like RT-PCR that evaluate samples directly for viral RNA using genomic sequencing. In addition, RT-PCR tests can also detect precise viral mutations or variants, but normally require labs with sophisticated equipment.

Part of RADx program

The company says FDA fast-tracked its emergency authorization review because the test was part of the Rapid Acceleration of Diagnostics, or RADx, program initiated by National Institutes of Health. The RADx project operates as a challenge competition to encourage development of new Covid-19 diagnostics, particular fast, inexpensive, and easy-to-use tests. Last month, FDA issued updated regulatory guidance to encourage development of more Covid-19 tests, particularly those returning rapid results and performed at home. The guidance notes FDA would focus on tests “for which the request is from, or supported by, a U.S. government stakeholder” such as the RADx program.

“The Covid-19 pandemic,” says Roche Diagnostics CEO Thomas Schinecker in a company statement, “continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities.” Matt Sause, president of Roche Diagnostics North America adds, “Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response.”

Roche says it plans to make the Covid-19 At-Home Test available for consumers in the U.S. next month, producing tens of millions of tests each month. The company also plans to integrate test results into its Navify Pass system for organizations to enable stakeholders to securely share their scores.

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