The Food and Drug Administration (FDA) is alerting patients and health care providers regarding the risk of false negative results for coronavirus disease 2019 (COVID-19) when using the Curative SARS-CoV-2 test (KorvaLabs Inc).
The Curative SARS-Cov-2 Assay is a real-time RT-PCR test intended to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using respiratory specimens collected by oropharyngeal swab, nasopharyngeal swab, nasal swab, or oral fluid specimens from an individual suspected of COVID-19. Once collected, the specimen is then processed at the KorvaLabs laboratory and results are returned to the patient.
According to the FDA’s safety communication, the test should be utilized in accordance with its Emergency Use Authorization and as described in the authorized labeling to reduce the risk of false negative results. Collection of specimens should be limited to symptomatic individuals within 14 days of COVID-19 symptom onset. Additionally, the specimen collection process should be observed and directed by a trained health care worker.
The FDA is advising health care providers to consider retesting patients using a different test if an inaccurate result is recently (less than 2 weeks) suspected using the Curative SARS-Cov-2 test. Any adverse events or suspected adverse events, including problems with test performance or results, should be reported to the FDA’s MedWatch program.
Risk of false results with the curative SARS-Cov-2 Test for COVID-19: FDA safety communication. [press release]. Silver Springs, MD: U.S. Food and Drug Administration; January 4, 2021.
This article originally appeared on MPR