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

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 t...

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Detalles Bibliográficos
Autores principales: Litchfield, Mark, Brookes, Paul, Ojrzynska, Agnieszka, Kavi, Janki, Dawood, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2022
Materias:
Short Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8863925/
https://www.ncbi.nlm.nih.gov/pubmed/35217170
http://dx.doi.org/10.1016/j.ijid.2022.02.032
Descripción
Sumario: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.

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