Evaluation of the Genmark ePlex® and QIAstat-Dx® respiratory pathogen panels in detecting bacterial targets in lower respiratory tract specimens

BMC Microbiol. 2021 Aug 26;21(1):236. doi: 10.1186/s12866-021-02289-w.

Abstract

Background: The ePlex® and QIAstat-Dx® respiratory pathogen panels detect multiple respiratory pathogens, mainly viruses but also Legionella pneumophila, Mycoplasma pneumoniae and Bordetella pertussis. The assays have been marketed for use in nasopharyngeal swab specimens. For diagnosing bacterial pneumonia, lower respiratory tract (LRT) specimens are indicated. Aim of this study was to evaluate the performance of these syndromic panels for these three bacterial targets in samples from the LRT. Fifty-six specimens were collected from our repositories, five negative samples and fifty-one samples which had been previously tested positive with the routine diagnostic real-time PCR assays for Legionella spp. (N = 20), Bordetella spp. (N = 16) or M. pneumoniae (N = 15).

Results: The QIAstat-Dx Respiratory Panel V2 (RP) assay detected all of the L. pneumophila and B. pertussis positive samples but only 11/15 (73.3 %) of the M. pneumoniae targets. The ePlex Respiratory Pathogen Panel (RPP) assay detected 10/14 (71.4 %) of the L. pneumophila targets, 8/12 (66.7 %) of the B. pertussis positive samples and 13/15 (86.7 %) of the M. pneumoniae targets.

Conclusions: No false-positive results were reported for all three bacterial pathogens by both assays. The clinical performance of both assays depended highly on the bacterial load in the sample and the type of specimen under investigation.

Keywords: Molecular diagnostics; QIAstat-Dx; Respiratory tract infections; Syndromic testing; ePlex.

Publication types

  • Evaluation Study

MeSH terms

  • Bacteria / classification
  • Bacteria / genetics*
  • Bacteria / isolation & purification
  • Bacteria / pathogenicity
  • Bacterial Load / methods
  • Bacterial Load / standards
  • Female
  • Humans
  • Male
  • Molecular Diagnostic Techniques / methods
  • Molecular Diagnostic Techniques / standards*
  • Multiplex Polymerase Chain Reaction / instrumentation
  • Multiplex Polymerase Chain Reaction / standards
  • Pneumonia, Bacterial / diagnosis
  • Pneumonia, Bacterial / microbiology
  • Reagent Kits, Diagnostic / standards*
  • Respiratory Tract Infections / diagnosis*
  • Respiratory Tract Infections / microbiology*

Substances

  • Reagent Kits, Diagnostic