This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories.* The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Guidance may include precautionary isolation procedures and a second mode of testing for confirmation. Please follow your institution and/or state and local guidance for addressing a patient with a positive test result. Understanding that false positive test results are a possibility is important. It is important to note that your institution’s specific prevalence rates can be used to calculate the potential for false positives in your facility. The infographic below demonstrates how very low, low, medium and high prevalence rates make a difference. When testing for SARS-CoV-2 in particular, It is important to understand how local disease prevalence rate and test performance characteristics may interact to influence the proportion of false positive test results compared to all positive results. In the case of antigen tests, results could be influenced by workflow inconsistencies, quality of the sample itself, or protocol failure, to name a few. While unusual, false positive results are a possible outcome in any diagnostic test. You’ve performed the test, now it’s time to understand the results.
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