Article ; Online: 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.
2022 Volume 122, Page(s) 864–866
Abstract: Objectives: This 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 ... ...
Abstract | Objectives: This 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). Methods: Nasopharyngeal 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. Results: Overall, 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. Conclusion: The NeuMoDx assay demonstrated high sensitivity and specificity on a platform well-suited for fully automated SARS-CoV-2 testing. |
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MeSH term(s) | COVID-19/diagnosis ; COVID-19 Testing ; Humans ; Polymerase Chain Reaction ; RNA, Viral/genetics ; SARS-CoV-2/genetics ; Sensitivity and Specificity |
Chemical Substances | RNA, Viral |
Language | English |
Publishing date | 2022-07-16 |
Publishing country | Canada |
Document type | Journal Article |
ZDB-ID | 1331197-9 |
ISSN | 1878-3511 ; 1201-9712 |
ISSN (online) | 1878-3511 |
ISSN | 1201-9712 |
DOI | 10.1016/j.ijid.2022.07.024 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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