Comparison of the clinical sensitivity and specificity of two commercial RNA SARS-CoV-2 assays.

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 ThermoFishe

SUBMITTER: Litchfield M 

PROVIDER: S-EPMC8863925 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature