The U.S. Food and Drug Administration (FDA) warned patients and healthcare providers of the risk of false results, particularly false negative results, with the Curative RT-PCR SARS-Cov-2 test, according to a safety communication from the agency.
To reduce the risk of false negative results, the FDA said providers should perform the test in accordance with its authorization and as described in the authorized labeling, including the following:
· Collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset.
· Specimen collection must be directly observed and directed during the sample collection process by a trained healthcare worker at the specimen collection site.
The FDA also said healthcare providers should consider retesting patients using a different test if they suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest, the FDA added.
The Curative SARS-Cov-2 Assay is authorized for prescription-only use. The test is performed by collecting a throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimen from an individual suspected of COVID-19 by their healthcare provider. Under the emergency use authorization, the specimen is processed at the KorvaLabs, with results then returned to the patient.
Based in San Dimas, CA, Curative was founded in 2020 initially to develop tests for sepsis but pivoted to SARS-CoV-2 testing in March 2020.
