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Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2.
J Clin Microbiol. 2020 Jul 23; 58(8)JC

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.

Authors+Show Affiliations

Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA.Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA.Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA.Department of Pathology and Laboratory Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, USA.Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA gberry1@northwell.edu. Department of Pathology and Laboratory Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, USA.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32332061

Citation

Zhen, Wei, et al. "Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Zhen W, Smith E, Manji R, et al. Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2. J Clin Microbiol. 2020;58(8).
Zhen, W., Smith, E., Manji, R., Schron, D., & Berry, G. J. (2020). Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.00783-20
Zhen W, et al. Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8) PubMed PMID: 32332061.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2. AU - Zhen,Wei, AU - Smith,Elizabeth, AU - Manji,Ryhana, AU - Schron,Deborah, AU - Berry,Gregory J, Y1 - 2020/07/23/ PY - 2020/04/16/received PY - 2020/04/22/accepted PY - 2020/4/26/pubmed PY - 2020/8/6/medline PY - 2020/4/26/entrez KW - COVID-19 KW - EUA KW - SARS-CoV-2 KW - molecular diagnostics KW - nasopharyngeal KW - near-patient testing JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32332061/Clinical_Evaluation_of_Three_Sample_to_Answer_Platforms_for_Detection_of_SARS_CoV_2_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32332061 DB - PRIME DP - Unbound Medicine ER -