Multicenter evaluation of the ePlex Respiratory Pathogen panel for the detection of viral and bacterial respiratory tract pathogens in nasopharyngeal swabs Journal Article
| Authors: | Babady, N. E.; England, M. R.; Jurcic Smith, K. L.; He, T.; Wijetunge, D. S.; Tang, Y. W.; Chamberland, R. R.; Menegus, M.; Swierkosz, E. M.; Jerris, R. C.; Greene, W. |
| Article Title: | Multicenter evaluation of the ePlex Respiratory Pathogen panel for the detection of viral and bacterial respiratory tract pathogens in nasopharyngeal swabs |
| Abstract: | The performance of the new ePlex Respiratory Pathogen (RP) panel (GenMark Diagnostics) for the simultaneous detection of 19 viruses (influenza A virus; influenza A H1 virus; influenza A 2009 H1 virus; influenza A H3 virus; influenza B virus; adenovirus; coronaviruses [HKU1, OC43, NL63, and 229E]; human rhinovirus/enterovirus; human metapneumovirus; parainfluenza viruses 1, 2, 3, and 4; and respiratory syncytial virus [RSV] [RSV subtype A and RSV subtype B]) and 2 bacteria (Mycoplasma pneumoniae and Chlamydia pneumoniae) was evaluated. Prospectively and retrospectively collected nasopharyngeal swab (NPS) specimens (n = 2,908) were evaluated by using the ePlex RP panel, with the bioMérieux/BioFire FilmArray Respiratory Panel (BioFire RP) as the comparator method. Discordance analysis was performed by using target-specific PCRs and bidirectional sequencing. The reproducibility of the assay was evaluated by using reproducibility panels comprised of 6 pathogens. The overall agreement between the ePlex RP and BioFire RP results was >95% for all targets. Positive percent agreement with the BioFire RP result for viruses ranged from 85.1% (95% confidence interval [CI], 80.2% to 88.9%) to 95.1% (95% CI, 89.0% to 97.9%), while negative percent agreement values ranged from 99.5% (95% CI, 99.1% to 99.7%) to 99.8% (95% CI, 99.5% to 99.9%). Additional testing of discordant targets (12%; 349/2,908) confirmed the results of ePlex RP for 38% (131/349) of samples tested. Reproducibility was 100% for all targets tested, with the exception of adenovirus, for which reproducibilities were 91.6% at low virus concentrations and 100% at moderate virus concentrations. The ePlex RP panel offers a new, rapid, and sensitive "sample-to-answer" multiplex panel for the detection of the most common viral and bacterial respiratory pathogens. Copyright © 2018 Babady et al. |
| Keywords: | retrospective studies; clinical trial; polymerase chain reaction; reproducibility; reproducibility of results; retrospective study; virology; multicenter study; diagnostic test; microbiology; isolation and purification; virus; respiratory tract infection; bacterium; nasopharynx; molecular diagnosis; molecular diagnostic techniques; bacteria; diagnostic tests, routine; viruses; respiratory tract infections; procedures; rapid diagnosis; humans; human; evaluation study; respiratory pathogens; multiplex syndromic panel; sample-to-answer test; rapid pcr |
| Journal Title: | Journal of Clinical Microbiology |
| Volume: | 56 |
| Issue: | 2 |
| ISSN: | 0095-1137 |
| Publisher: | American Society for Microbiology |
| Date Published: | 2018-02-01 |
| Start Page: | e01353-17 |
| Language: | English |
| DOI: | 10.1128/jcm.01658-17 |
| PUBMED: | 29212701 |
| PROVIDER: | scopus |
| PMCID: | PMC5786739 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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