PERFORMANCE OF THE COBAS® INFLUENZA A/B ASSAY FOR RAPID PCR-BASED DETECTION OF INFLUENZA COMPARED TO PRODESSE ProFlu+ AND VIRAL CULTURE

Rapid and accurate diagnosis of influenza is important for patient management and infection control. We determined the performance of the cobas (R) Influenza A/B assay, a rapid automated nucleic acid assay performed on the cobas (R) Liat System for qualitative detection of influenza A and influenza B from nasopharyngeal (NP) swab specimens. Retrospective frozen and prospectively collected NP swabs from patients with signs and symptoms of influenza collected in universal transport medium (UTM) were tested at multiple sites including CLIA-waived sites using the cobas (R) Influenza A/B assay. Results were compared to the Prodesse ProFlu+ assay and to viral culture. Compared to the Prodesse ProFlu+ Assay, sensitivities of the cobas (R) Influenza A/B assay for influenza A and B were 97.7 and 98.6%, respectively; specificity was 99.2 and 99.4%. Compared to viral culture, the cobas (R) Influenza A/B assay showed sensitivities of 97.5 and 96.9% for influenza virus A and B, respectively; specificities were 97.9% for both viruses. Polymerase chain reaction (PCR)/sequencing showed that the majority of viral culture negative but cobas (R) Influenza A/B positive results were true positive results, indicating that the cobas (R) Influenza A/B assay has higher sensitivity compared to viral culture. In conclusion, the excellent accuracy, rapid time to result, and remarkable ease of use make the cobas (R) Influenza A/B nucleic acid assay for use on the cobas (R) Liat System a highly suitable point-of-care solution for the management of patients with suspected influenza A and B infection.