About: Analytical evaluation of the microarray-based FluChip-8G Influenza A+B Assay

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An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Analytical evaluation of the microarray-based FluChip-8G Influenza A+B Assay
Creator	Smith, Catherine Blair, Rebecca Dawson, Erica Johnson, James Liikanen, Kyle Rowlen, Kathy Slinskey, Amelia Smolak, Andrew Stoughton, Robert Talbot, Sarah Taylor, Amber Toth, Evan
source	Elsevier; Medline; PMC
abstract	Abstract Background Influenza causes a significant annual disease burden, with characterization of the infecting virus important in clinical and public health settings. Rapid immunoassays are fast but insensitive, whereas real-time RT-PCR is sensitive but susceptible to genetic mutations and often requires multiple serial assays. The FluChip-8G Influenza A+B Assay provides type and subtype/lineage identification of influenza A and B, including non-seasonal A viruses, in a single microarray-based assay with same day turnaround time. Objective To evaluate key analytical performance characteristics of the FluChip-8G Influenza A+B Assay. Study design Analytical sensitivity, cross-reactivity, and multi-site reproducibility were evaluated. Results The limit of detection (LOD) for the FluChip-8G influenza A+B Assay ranged from 5.8 × 102–1.5 × 105 genome copies/mL, with most samples ∼2 × 103 genome copies/mL (∼160 genome copies/reaction). Fifty two (52) additional strains were correctly identified near the LOD, demonstrating robust reactivity. Two variant viruses (H1N1v and H3N2v) resulted in dual identification as both “non-seasonal influenza A” and A/H1N1pdm09. No reproducible cross-reactivity was observed for the 34 organisms tested, however, challenges with internal control inhibition due to crude growth matrix were observed. Lastly, samples tested near the LOD showed high reproducibility (97.0% (95% CI 94.7–98.7)) regardless of operator, site, reagent lot, or testing day. Conclusion The FluChip-8G Influenza A+B Assay is an effective new method for detecting and identifying both seasonal and non-seasonal influenza viruses, as revealed by good sensitivity and robust reactivity to 52 unique strains of influenza virus. In addition, the lack of cross-reactivity to non-influenza pathogens and high lab-to-lab reproducibility highlight the analytical performance of the assay as an alternative to real-time RT-PCR and sequencing-based assays. Clinical validation of the technology in a multi-site clinical study is the subject of a separate investigation.
has issue date	2019-11-30(xsd:dateTime)
bibo:doi	10.1016/j.jviromet.2019.113686
bibo:pmid	31271790
has license	els-covid
sha1sum (hex)	21309c53f0a15cfb0a81750e81d4bad141f9c01c
schema:url	https://doi.org/10.1016/j.jviromet.2019.113686
resource representing a document's title	Analytical evaluation of the microarray-based FluChip-8G Influenza A+B Assay
has PubMed Central identifier	PMC6779046
has PubMed identifier	31271790
schema:publication	Journal of Virological Methods
resource representing a document's body	covid:21309c53f0a15cfb0a81750e81d4bad141f9c01c#body_text
is schema:about of	named entity 'clinical study' named entity 'Influenza A' named entity 'Assay' named entity 'sensitive' named entity 'high' named entity 'LOD' named entity 'dual' named entity 'disease burden' named entity 'Two' named entity 'alternative' named entity 'assays' named entity 'Influenza A' covid:arg/21309c53f0a15cfb0a81750e81d4bad141f9c01c named entity 'serial' named entity 'LOD' named entity 'reagent' named entity 'Conclusion' named entity 'robust' named entity 'site' named entity 'Rapid' named entity 'robust' named entity 'matrix' named entity 'cross-reactivity' named entity 'Influenza A' named entity 'influenza' named entity 'detection' named entity 'key' named entity 'annual' named entity 'reproducibility' named entity '95% CI' named entity 'seasonal influenza' named entity 'real-time RT-PCR' named entity 'reproducibility' named entity 'real-time RT-PCR' named entity 'FluChip' named entity '94.7' named entity 'genome' named entity 'limit of detection' named entity 'LOD' named entity 'public health' named entity 'microarray' named entity 'influenza' named entity 'LOD' named entity 'sensitivity' named entity 'infecting' named entity 'strains' named entity 'assays' named entity 'bacteria' named entity 'DNA microarray' named entity 'H1N1pdm09' named entity 'influenza' named entity 'reassortant' named entity 'biosafety' named entity 'viruses' named entity 'influenza' named entity 'oligonucleotide' named entity 'influenza' named entity 'FluChip' named entity 'virus' named entity 'influenza' named entity 'gene' named entity 'FluChip' named entity 'FluChip' named entity 'viruses' named entity 'cfu' named entity 'FluChip' named entity 'influenza' named entity 'reagent' named entity 'viral RNA' named entity 'influenza'

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