FDA grants EUA to at-home COVID-19 test

Jan. 26, 2022

Maxim Biomedical received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for an at-home antigen COVID-19 test, and the company plans to launch the test in February or March.

The ClearDetect COVID-19 Antigen Home Test employs Lateral Flow Assay (LFA) technology. The test's format involves only 3 components — a swab, a test strip, and a test tube pre-filled with sample buffer. Results are available in 15 minutes.

The company contends that the test performed well, when compared to an EUA-authorized PCR method, achieving 86.9% positive agreement (PPA) and 98.9% negative agreement (NPA). The test also performed favorably when evaluated by the NIH with specimens positive for the Omicron variant, detecting 100% of live virus Omicron samples diluted to a PCR Ct value of 25.8.

The test will be available in two kit configurations — packaged two (2) tests in a box for at-home use, and in a bulk 25-test pack amenable for healthcare settings, schools, workplaces, and other high-volume testing scenarios, according to the company.

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