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

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Article number	104737
Journal	Journal of Clinical Virology
Volume	135
DOIs	https://doi.org/10.1016/j.jcv.2021.104737
State	Published - Feb 2021

Keywords

GenMark
Panels
SARS-CoV-2
ePlex

ASJC Scopus subject areas

Virology
Infectious Diseases

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10.1016/j.jcv.2021.104737

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

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",

author = "Junko Jarrett and Katharine Uhteg and Forman, {Michael S.} and Ann Hanlon and Christine Vargas and Carroll, {Karen C.} and Alexandra Valsamakis and Mostafa, {Heba H.}",

note = "Funding Information: We thank the entire JHH Medical Microbiology division for their assistance with this study. We also thank GenMark Dx for providing ePlex cartridges for test evaluation. Publisher Copyright: {\textcopyright} 2021 Elsevier B.V. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

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doi = "10.1016/j.jcv.2021.104737",

language = "English (US)",

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AU - Jarrett, Junko

AU - Uhteg, Katharine

AU - Forman, Michael S.

AU - Hanlon, Ann

AU - Vargas, Christine

AU - Carroll, Karen C.

AU - Valsamakis, Alexandra

AU - Mostafa, Heba H.

N1 - Funding Information: We thank the entire JHH Medical Microbiology division for their assistance with this study. We also thank GenMark Dx for providing ePlex cartridges for test evaluation. Publisher Copyright: © 2021 Elsevier B.V. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/2

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N2 - 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.

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

Abstract

Keywords

ASJC Scopus subject areas

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