Abstract
ObjectivesThis 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). MethodsOverall, 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. ResultsBy 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). ConclusionsThe 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.
Highlights
Responding to the COVID-19 pandemic, researchers have developed several diagnostic assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
In 2019, legislation brought UK rt-PCR testing under regulation by UK Accreditation Service (UKAS), against standards imposed by the Department of Health & Social Care (DHSC)
The most stringent standard applied to travellers from destinations deemed high risk, on Day 2 after arrival (Department of Health and Social Care, 2021)
Summary
Responding to the COVID-19 pandemic, researchers have developed several diagnostic assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). Automation in molecular diagnostics enables scaling of testing capacity, which is critical for enabling a large number of tests (Eigner et al, 2019). Many published validation studies for SARS-CoV-2 assays have low sample numbers, differences in processes and lack of validation by independent third parties (Vandenberg et al, 2021). In 2019, legislation brought UK rt-PCR testing under regulation by UK Accreditation Service (UKAS), against standards imposed by the Department of Health & Social Care (DHSC). The most stringent standard applied to travellers from destinations deemed high risk, on Day 2 after arrival (Department of Health and Social Care, 2021)
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