Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification

Abstract

BackgroundThe FluChip-8G Influenza A+B Assay is a multiplexed influenza RT-PCR and microarray-based assay with same day turnaround time, developed to subtype seasonal A viruses (H1N1pdm2009 and H3N2), distinguish B viruses as Yamagata or Victoria lineage, and is the only FDA cleared assay capable of positive identification of a wide variety of A subtypes as “non-seasonal” A viruses from human nasal specimens. ObjectiveTo evaluate clinical performance of the FluChip-8G Influenza A+B Assay for detection of seasonal influenza viruses in nasal and nasopharyngeal swab specimens, and to evaluate performance for detection of non-seasonal influenza viruses using contrived samples. Study DesignFor seasonal viruses, a multisite study of the FluChip-8G Influenza A+B Assay using prospectively and retrospectively collected nasal and nasopharyngeal swabs was performed using the FDA-cleared CDC Human Flu Dx Panel as the comparator assay. For non-seasonal viruses, testing was performed at a single site using contrived samples from 100 unique non-seasonal strains representing 41 subtypes. ResultsSensitivity (95% CI) and specificity (95% CI) for each target group, respectively, from results of 1689 clinical specimens were: seasonal H1N1pdm2009: 96.4% (87.9–99.0), 99.3% (98.8–99.6), seasonal H3N2: 91.8% (87.7–94.7), 99.7% (99.2–99.9), Influenza B Victoria: 100% (94.0–100.0), 99.9% (99.6–100.0), and Influenza B Yamagata: 95.6% (89.2–98.3), 99.9% (99.6–100.0). The sensitivity and specificity from contrived influenza A non-seasonal viruses was determined to be 99.0% (94.6–99.8) and 100% (96.7–100.0). ConclusionThe FluChip-8G Influenza A+B Assay has robust sensitivity and specificity for detecting and identifying all target virus groups, including non-seasonal influenza A, with same day results.