The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and
qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic
patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor
System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral
antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza
A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral
culture or an FDA-cleared influenza A and B molecular assay. Outside the U.S., a negative test is presumptive and it is
recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country
of use. FDA has not cleared this device for use outside of the U.S. Negative test results do not preclude influenza viral
infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not
intended to detect influenza C antigens.
Performance characteristics for influenza A and B were established during January through March of 2011 when influenza
viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in
circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled “Update: Influenza Activity—United
States, 2010–2011 Season, and Composition of the 2011–2012 Influenza Vaccine.” Performance characteristics may vary
against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria
recommended by public health authorities, specimens should be collected with appropriate infection control precautions
for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. – Read IFU for more information.