Abstract
ABSTRACTThe 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.
Highlights
Respiratory tract infections are a significant contributor to the global burden of respiratory tract illnesses, with up to 4 million deaths worldwide in 2013 [1]
Positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA) with the comparator method results or expected results were determined for each target detected by the ePlex Respiratory Pathogen (RP) panel
A total of 2,462 prospectively collected, 446 retrospectively collected, and 327 contrived samples were eligible for testing with the ePlex RP panel
Summary
Respiratory tract infections are a significant contributor to the global burden of respiratory tract illnesses, with up to 4 million deaths worldwide in 2013 [1]. Several instruments and multiplexed molecular panels are currently approved by the U.S Food and Drug Administration (FDA) for the rapid and sensitive detection of viral and bacterial respiratory pathogens in nasopharyngeal swab (NPS) specimens These methods differ based on several criteria, including the degree of multiplexing (4 to 22 targets), complexity of the method (moderate to high), throughput (low to high), and turnaround time (TAT) (ϳ1 h to 8 h) [9]. The ePlex RP panel is a sample-to-answer multiplex assay that runs on a single-use cartridge that automates all aspects of nucleic acid testing, including extraction, amplification, and detection It combines electrowetting microfluidics and GenMark’s eSensor technology, which is based on the principles of competitive DNA hybridization and electrochemical detection, as previously described for the GenMark XT-8 Respiratory Viral panel [11]. In addition to assay performance, other characteristics, including assay workflow and turnaround time, were evaluated
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
