Comparison of the clinical sensitivity and specificity of two commercial RNA SARS-CoV-2 assays. (May 2022)

• Record Type: Journal Article
• Authors: Litchfield, Mark; Brookes, Paul; Ojrzynska, Agnieszka; Kavi, Janki; Dawood, Richard
• Is Part Of: International journal of infectious diseases. Volume 118(2022)
• Page Start: 194
• Page End: 196
• Publication Date: 2022-05
• Subjects: COVID-19 -- Diagnostic assay -- NeuMoDx -- RT-PCR -- Rapid testing -- SARS-CoV-2; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2022.02.032
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: The NeuMoDx™ SARS-CoV-2 Assay showed similar performance to the reference method. The assay had a clinical specificity of 100% and sensitivity of 98.73%. The assay's limit of detection was 150 copies/mL, exceeding acceptability criteria. The NeuMoDx 96 Molecular System had a throughput of 144 samples over 8 hours. 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.