Clinical performance of the GenMark Dx ePlex respiratory pathogen panels for upper and lower respiratory tract infections

Junko Jarrett; Katharine Uhteg; Michael S Forman; Ann Hanlon; Christine Vargas; Karen C Carroll; Alexandra Valsamakis; Heba H Mostafa

doi:10.1016/j.jcv.2021.104737

Clinical performance of the GenMark Dx ePlex respiratory pathogen panels for upper and lower respiratory tract infections

J Clin Virol. 2021 Feb:135:104737. doi: 10.1016/j.jcv.2021.104737. Epub 2021 Jan 15.

Authors

Junko Jarrett¹, Katharine Uhteg¹, Michael S Forman², Ann Hanlon¹, Christine Vargas¹, Karen C Carroll³, Alexandra Valsamakis³, Heba H Mostafa⁴

Affiliations

¹ Johns Hopkins Hospital Medical Microbiology Laboratory, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA.
² Johns Hopkins School of Medicine, Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA.
³ Johns Hopkins Hospital Medical Microbiology Laboratory, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA; Johns Hopkins School of Medicine, Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA.
⁴ Johns Hopkins Hospital Medical Microbiology Laboratory, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA; Johns Hopkins School of Medicine, Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA. Electronic address: hmostaf2@jhmi.edu.

PMID: 33497932
DOI: 10.1016/j.jcv.2021.104737

Abstract

The GenMark Dx ePlex Respiratory Pathogen Panel (RP) is a multiplexed nucleic acid test for the qualitative detection of common viral and a few bacterial causes of respiratory tract infections. The ePlex RP has received FDA clearance for nasopharyngeal swab (NPS) specimens collected in viral transport media. In this study, we evaluated the performance of the ePlex RP panel in comparison to the NxTAG Respiratory Pathogen Panel (NxTAG-RPP) from Luminex in use in our laboratory, not only for NPS but also for bronchoalveolar lavage specimens (BAL). We also evaluated the impact of implementing the ePlex RP on the test turn-around time (TAT). The newest panel from GenMark Dx, the ePlex Respiratory Pathogen Panel 2 (RP2), which added the SARS-CoV-2 target to the RP was also evaluated for NPS. Verification of the performance of the ePlex RP for both NPS and BAL showed 93.3 % and 84.9 % total agreement with the NxTAG-RPP respectively. An overall comparison of the TAT after implementing the ePlex RP as compared to the NxTAG-RPP assay showed an average decrease of almost seven-fold.

Keywords: GenMark; Panels; SARS-CoV-2; ePlex.

MeSH terms

Bronchoalveolar Lavage / methods
COVID-19 / diagnosis
Diagnostic Tests, Routine / methods*
Humans
Molecular Diagnostic Techniques / methods*
Multiplex Polymerase Chain Reaction / methods*
Nasopharynx / microbiology
Nasopharynx / virology
Respiratory Tract Infections / diagnosis*
Respiratory Tract Infections / microbiology
Respiratory Tract Infections / virology
SARS-CoV-2 / genetics