Rapid Antigen Test Kits for COVID-19

FDA Releases Memorandum for Certification

Antigen Tests Proved Sensitive as PCR Tests

On March 23, 2021, the Food and Drug Administration (FDA) issued FDA Memorandum No. WEB Panbio COVID-19 Antigen Self-Test with Pre-Filled Buffer Tube and Short Nasal Swab Test Procedure Video.

The memorandum establishes guidance for the certification of COVID-19 rapid antigen test kits for use with anterior nasal swabs collected by individuals.

The reference assay for rapid antigen test kit evaluation is RT-PCR. Rapid antigen detection tests using self-collected anterior nasal swabs proved to be as sensitive as RT-PCR tests and thus meet the FDA's criteria for at-home use.

These kits can be used by individuals to detect SARS-CoV-2 antigen from nasal swabs of probable COVID-19 patients.

The FDA's certification process provides assurance that the test kits are accurate, reliable, and safe for use by the public.

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