Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification.
J Clin Virol
; 118: 20-27, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31382226
ABSTRACT
BACKGROUND:
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.OBJECTIVE:
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. STUDYDESIGN:
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.RESULTS:
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).CONCLUSION:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vírus da Influenza A
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Vírus da Influenza B
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Reação em Cadeia da Polimerase Via Transcriptase Reversa
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Técnicas de Diagnóstico Molecular
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Análise em Microsséries
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Influenza Humana
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Técnicas de Genotipagem
Tipo de estudo:
Diagnostic_studies
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Evaluation_studies
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Observational_studies
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Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article