Dataset Information
Comparison of the clinical sensitivity and specificity of two commercial RNA SARS-CoV-2 assays.
Ontology highlight
ABSTRACT: Objectives
This study aimed to compare the performance of the NeuMoDx™ SARS-CoV-2 Assay, implemented on the NeuMoDx 96 Molecular System, with that of the ThermoFisher TaqPath™ COVID-19 CE-IVD RT-PCR Kit (reference method).Methods
Overall, 450 nasopharyngeal swab samples, previously tested using the reference method, were tested by the NeuMoDx Assay, and the clinical sensitivity and specificity of the assay were analyzed.Results
By retrospective statistical analysis of all valid results, the NeuMoDx Assay had a clinical specificity of 100% (95% confidence interval [CI]: 98.65-100.00) and a clinical sensitivity of 98.73% (95% CI: 95.47-99.85).Conclusions
The NeuMoDx SARS-CoV-2 Assay demonstrated comparable analytical and clinical performance to the ThermoFisher TaqPath COVID-19 CE-IVD RT-PCR Kit. The NeuMoDx 96 Molecular System is well suited for automating medium-throughput routine SARS-CoV-2 testing or as an addition to high-throughput systems to allow fast-tracking for highly urgent clinical samples.
SUBMITTER: Litchfield M
PROVIDER: S-EPMC8863925 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
Publications
Comparison of the clinical sensitivity and specificity of two commercial RNA SARS-CoV-2 assays.
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20220223
<h4>Objectives</h4>This study aimed to compare the performance of the NeuMoDx™ SARS-CoV-2 Assay, implemented on the NeuMoDx 96 Molecular System, with that of the ThermoFisher TaqPath™ COVID-19 CE-IVD RT-PCR Kit (reference method).<h4>Methods</h4>Overall, 450 nasopharyngeal swab samples, previously tested using the reference method, were tested by the NeuMoDx Assay, and the clinical sensitivity and specificity of the assay were analyzed.<h4>Results</h4>By retrospective statistical analysis of all ...[more]