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

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Rebecca H BlairKathy L Rowlen

Abstract

The 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. To 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. For 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. Sensitivity (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), ...Continue Reading

References

Apr 12, 2012·Clinical Microbiology Reviews·Swati Kumar, Kelly J Henrickson
May 3, 2013·Journal of Virology·Zhixin FengXiu-Feng Wan
Sep 16, 2018·Viruses·Ahmed MostafaStephan Pleschka
Mar 2, 2019·Tropical Medicine and Infectious Disease·Joanna A Pulit-PenalozaTaronna R Maines
Jul 5, 2019·Journal of Virological Methods·Amber W TaylorKathy L Rowlen

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Citations

Dec 4, 2020·Journal of Virological Methods·John Mark VelascoChonticha Klungthong
Mar 19, 2021·Tropical Diseases, Travel Medicine and Vaccines·Emily S BaileyGregory C Gray

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