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# FDA Caution on Covid Antigen Test False Positives
- URL: https://www.fdaweb.com/fda-caution-on-covid-antigen-test-false-positives/
- Published: 2020-11-03T12:00:00.000Z
- Updated: 2026-09-14T16:35:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148010

FDA says clinical laboratory staff and healthcare providers should be aware that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SATS-CoV-2\. An agency [statement](https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-results-antigen-tests-rapid-detection-sars-cov-2-letter-clinical-laboratory?ref=fdaweb.com) says laboratories “should expect some false positive results to occur even when very accurate tests are used for screening large populations with a low prevalence of infection.”

The statement contains recommendations for laboratory staff and healthcare providers who use antigen tests for the rapid detection of SARS-CoV-2.