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# Alert on Covid Test False Negatives
- URL: https://www.fdaweb.com/alert-on-covid-test-false-negatives/
- Published: 2021-01-05T12:00:00.000Z
- Updated: 2026-09-14T16:41:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148383

FDA has issued a [safety alert](https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication?ref=fdaweb.com) about false result risks (mostly false negatives) with KorvaLabs’ Curative SARS-Cov-2 (Covid-19) test. To reduce the risk of false negative results, it is important to perform the test in accordance with its [emergency use authorization](https://www.fda.gov/media/137089/download?ref=fdaweb.com) and as described in the authorized labeling, e.g., the [Fact Sheet for Healthcare Providers](https://www.fda.gov/media/137087/download?ref=fdaweb.com), the alert says.

According to the test’s [labeling](https://www.fda.gov/media/137087/download?ref=fdaweb.com), collection of nasal swabs and oral fluid specimens is limited to individuals who have shown symptoms of Covid-19 within 14 days of onset of the symptoms. “Consistent with the [EUA summary](https://www.fda.gov/media/137089/download?ref=fdaweb.com), negative results for SARS-CoV-2 RNA from oral fluid specimens should be confirmed by testing of another specimen type authorized for use with this test if clinically indicated,” the alert says.