tetano
Editor, Senior Moderator
J Clin Virol. 2019 Jul 26;118:20-27. doi: 10.1016/j.jcv.2019.07.008. [Epub ahead of print]
[h=1]Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification.[/h] Blair RH[SUP]1[/SUP], Dawson ED[SUP]2[/SUP], Taylor AW[SUP]1[/SUP], Johnson JE Jr[SUP]1[/SUP], Slinskey AH[SUP]1[/SUP], O'Neil K[SUP]1[/SUP], Smolak AW[SUP]1[/SUP], Toth E[SUP]1[/SUP], Liikanen K[SUP]1[/SUP], Stoughton RS[SUP]1[/SUP], Smith CB[SUP]3[/SUP], Talbot S[SUP]3[/SUP], Rowlen KL[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] 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.
[h=4]STUDY DESIGN:[/h] 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.
[h=4]RESULTS:[/h] 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), 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).
[h=4]CONCLUSION:[/h] The 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.
Copyright ? 2019 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Clinical performance; Diagnostic validation; FluChip-8G influenza A+B assay; Influenza subtyping; Microarray; multiplex RT-PCR
PMID: 31382226 DOI: 10.1016/j.jcv.2019.07.008
[h=1]Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification.[/h] Blair RH[SUP]1[/SUP], Dawson ED[SUP]2[/SUP], Taylor AW[SUP]1[/SUP], Johnson JE Jr[SUP]1[/SUP], Slinskey AH[SUP]1[/SUP], O'Neil K[SUP]1[/SUP], Smolak AW[SUP]1[/SUP], Toth E[SUP]1[/SUP], Liikanen K[SUP]1[/SUP], Stoughton RS[SUP]1[/SUP], Smith CB[SUP]3[/SUP], Talbot S[SUP]3[/SUP], Rowlen KL[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] 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.
[h=4]STUDY DESIGN:[/h] 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.
[h=4]RESULTS:[/h] 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), 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).
[h=4]CONCLUSION:[/h] The 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.
Copyright ? 2019 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Clinical performance; Diagnostic validation; FluChip-8G influenza A+B assay; Influenza subtyping; Microarray; multiplex RT-PCR
PMID: 31382226 DOI: 10.1016/j.jcv.2019.07.008