Curative’s COVID-19 Test May Give False Results, FDA Warns
The FDA has issued an alert for Curative’s real-time reverse transcription polymerase chain reaction (RT-PCR) SARS-CoV-2 test, warning that the test bears a risk of false results — particularly false negative results.
The prescription-only test uses throat swabs, nasopharyngeal swabs, nasal swabs or oral fluid samples. The agency warned that a false negative result could lead infected patients to delay or skip treatment or lead to a lack of monitoring of infected individuals and households.
Healthcare providers that used the test and suspect a recent inaccurate result should consider retesting patients with a different COVID-19 test, the agency said.