ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2022
Validation of the NeuMoDx™ SARS-CoV-2 assay with COPAN eNAT® and E&O Viral PCR Sample Solution collection media types in comparison with other validated SARS-CoV-2 RNA assays.
Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesThis study aimed to confirm NeuMoDx™ SARS-CoV-2 assay (NeuMoDx assay) functionality using off-label collection media, determine assay performance versus other SARS-CoV-2 RNA assays, and assess any cross-reactivity with other respiratory viruses (human coronavirus NL63, influenza, and respiratory syncytial virus).
methodsNasopharyngeal swab samples in off-label collection media and external quality assessment (EQA) samples were dual-tested, first using either the RealStar® SARS-CoV-2 reverse transcriptase polymerase chain reaction assay or the QIAstat-Dx® Respiratory SARS-CoV-2 Panel and then using the NeuMoDx assay. Samples found to be positive for respiratory viruses and negative for SARS-CoV-2 were then tested using the NeuMoDx assay to assess cross-reactivity.
resultsOverall, 274 samples (244 patient and 30 EQA samples) were dual-tested; 154 were SARS-CoV-2 positive and 120 were negative. No false-positive or false-negative results were identified, regardless of collection medium used. The NeuMoDx assay sensitivity was 100% (95% confidence interval [CI] 97.63-100.00) and the specificity was 100% (95% CI 96.97-100.00). The assay did not exhibit any cross-reactivity with other respiratory viruses.
conclusionThe NeuMoDx assay demonstrated high sensitivity and specificity on a platform well-suited for fully automated SARS-CoV-2 testing.
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