tetano
Editor, Senior Moderator
J Clin Microbiol. 2020 Apr 24. pii: JCM.00783-20. doi: 10.1128/JCM.00783-20. [Epub ahead of print]
Clinical Evaluation of Three Sample-To-Answer Platforms for the Detection of SARS-CoV-2.
Zhen W[SUP]1[/SUP], Smith E[SUP]1[/SUP], Manji R[SUP]1[/SUP], Schron D[SUP]2[/SUP], Berry GJ[SUP]3,[/SUP][SUP]2[/SUP].
Author information
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], 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 the Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/mL), followed by the ePlex (100% detection at 1,000 copies/mL), and the ID NOW (20,000 copies/mL). The Xpert Xpress also had highest positive percent agreement (PPA) when compared to our reference standard (98.3%) followed by the ePlex (91.4%) and ID now (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, the ID NOW produced the most rapid time to result per specimen (∼17 minutes) as compared to the Xpert Xpress (∼46 minutes) and the ePlex (∼1.5 hours), but what the ID NOW gained in rapid results, it lost in analytical and clinical performance. The ePlex had the longest time to results and showed a slight improvement in PPA over the 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 platform.
Copyright ? 2020 Zhen et al.
PMID:32332061DOI:10.1128/JCM.00783-20
Clinical Evaluation of Three Sample-To-Answer Platforms for the Detection of SARS-CoV-2.
Zhen W[SUP]1[/SUP], Smith E[SUP]1[/SUP], Manji R[SUP]1[/SUP], Schron D[SUP]2[/SUP], Berry GJ[SUP]3,[/SUP][SUP]2[/SUP].
Author information
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], 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 the Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/mL), followed by the ePlex (100% detection at 1,000 copies/mL), and the ID NOW (20,000 copies/mL). The Xpert Xpress also had highest positive percent agreement (PPA) when compared to our reference standard (98.3%) followed by the ePlex (91.4%) and ID now (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, the ID NOW produced the most rapid time to result per specimen (∼17 minutes) as compared to the Xpert Xpress (∼46 minutes) and the ePlex (∼1.5 hours), but what the ID NOW gained in rapid results, it lost in analytical and clinical performance. The ePlex had the longest time to results and showed a slight improvement in PPA over the 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 platform.
Copyright ? 2020 Zhen et al.
PMID:32332061DOI:10.1128/JCM.00783-20