Clinical performance evaluation of the BD Veritor System Flu A+B assay.

Abstract Early identification of influenza is important for optimal patient management and infection control. Rapid influenza antigen tests have been used routinely in clinical settings to confirm clinical suspicion, despite their low sensitivity. To improve sensitivity, various influenza point-of-care test reader systems have been developed. This study evaluated the clinical performance of a digital readout rapid influenza diagnostic test (RIDT), the BD Veritor™ System Flu A + B assay (BD). Nasopharyngeal swabs taken from 250 patients (influenza A positive, n  = 75; influenza B positive, n  = 75; and influenza negative, n  = 100) were analyzed using the BinaxNOW ® Influenza A/B antigen kit (BN), SD Influenza Ag A/B kit (SD), BD, real-time reverse transcriptase polymerase chain reaction (RT-PCR), and an influenza virus culture. Compared to RT-PCR, the sensitivities of BN, SD, and BD were 56.0, 53.3, and 72.0%, respectively, for influenza A and 57.3, 65.3, and 69.3%, respectively, for influenza B. No false-positive results were noted with the three rapid antigen tests. For influenza A, the average RT-PCR threshold cycle (Ct) for specimens that tested positive using BD was higher than that for specimens that tested positive using BN and SD. BD is a sensitive and easy method for the early detection of influenza A and B.