The FDA yesterday alerted healthcare providers and patients that there is a risk of false results with the Curative SARS-CoV-2 test.
The Curative SARS-CoV-2 assay is authorized for prescription-only use as a real-time RT-PCR test used to detect the virus causing COVID-19. The test analyzes throat swabs, nasopharyngeal swabs, nasal swabs and/or oral fluid specimens from an individual suspected of having COVID-19 by their healthcare provider, according to an FDA release.
Under the FDA emergency use authorization (EUA), the specimen collected for the Curative SARS-CoV-2 assay is to be processed at the KorvaLabs laboratory before results are returned to the patient.
According to the FDA, the risk of false results, particularly false-negative results, could lead to delayed treatment or an overall lack of treatment, as well as a lack of monitoring for infected individuals and their household or other close contacts, resulting in a risk of further spreading of COVID-19.
Healthcare providers and patients who may be affected are instructed by the FDA to consider retesting using a different test if they suspect that an inaccurate result was recently given by the Curative SARS-CoV-2 test.