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. (September 2022)

• Record Type: Journal Article
• Authors: Baird, Daniel; Muir, Alana; Logan, Lisa; MacLennan, Mairiead
• Is Part Of: International journal of infectious diseases. Volume 122(2022)
• Page Start: 864
• Page End: 866
• Publication Date: 2022-09
• Subjects: COVID-19 -- SARS-CoV-2 -- Diagnostic assay -- NeuMoDx -- RT-PCR -- Rapid testing; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2022.07.024
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: The NeuMoDx™ SARS-CoV-2 assay performance was similar to that of other validated assays Two types of off-label collection media were validated for use with the assay Assay sensitivity was 100% (95% confidence interval [CI] 97.63-100.00), regardless of collection medium Assay specificity was 100% (95% CI 96.97-100.00) The assay did not exhibit cross-reactivity with another commonly detected coronavirus 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.