Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs

• Published in: Journal of clinical microbiology Vol. 56; no. 2
• Main Authors: Babady, N. Esther, England, Matthew R., Jurcic Smith, Kristen L., He, Taojun, Wijetunge, Dona Saumya, Tang, Yi-Wei, Chamberland, Robin R., Menegus, Marilyn, Swierkosz, Ella M., Jerris, Robert C., Greene, Wallace
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 01.02.2018
• Subjects: Bacteria - isolation & purification; Diagnostic Tests, Routine; Humans; Molecular Diagnostic Techniques - methods; Nasopharynx - microbiology; Nasopharynx - virology; Polymerase Chain Reaction; Reproducibility of Results; Respiratory Tract Infections - diagnosis; Respiratory Tract Infections - microbiology; Respiratory Tract Infections - virology; Retrospective Studies; Virology; Viruses - isolation & purification; multiplex syndromic panel; rapid PCR; respiratory tract infections; sample-to-answer test; respiratory pathogens; rapid diagnosis
• ISSN: 0095-1137; 1098-660X; 1098-660X
• DOI: 10.1128/JCM.01658-17

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.