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
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 res...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-09-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971222004180 |
| _version_ | 1828114348066734080 |
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| author | Daniel Baird Alana Muir Lisa Logan Mairiead MacLennan |
| author_facet | Daniel Baird Alana Muir Lisa Logan Mairiead MacLennan |
| author_sort | Daniel Baird |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T12:23:40Z |
| format | Article |
| id | doaj.art-7242176cb14346dea6b63ae9b4339899 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-04-11T12:23:40Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-7242176cb14346dea6b63ae9b43398992022-12-22T04:24:02ZengElsevierInternational Journal of Infectious Diseases1201-97122022-09-01122864866Validation 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 assaysDaniel Baird0Alana Muir1Lisa Logan2Mairiead MacLennan3Department of Medical Microbiology and Infection Control, North Laboratory, Victoria Hospital, NHS Fife, Kirkcaldy, United KingdomDepartment of Medical Microbiology and Infection Control, North Laboratory, Victoria Hospital, NHS Fife, Kirkcaldy, United KingdomDepartment of Medical Microbiology and Infection Control, North Laboratory, Victoria Hospital, NHS Fife, Kirkcaldy, United KingdomCorrespondence to: Mairiead MacLennan, Department of Medical Microbiology and Infection Control, North Laboratory, Victoria Hospital, Hayfield Road, Kirkcaldy KY2 5AG, UK. Tel: +44 (0) 1592 648 157.; Department of Medical Microbiology and Infection Control, North Laboratory, Victoria Hospital, NHS Fife, Kirkcaldy, United KingdomObjectives: 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.http://www.sciencedirect.com/science/article/pii/S1201971222004180COVID-19SARS-CoV-2Diagnostic assayNeuMoDxRT-PCRRapid testing |
| spellingShingle | Daniel Baird Alana Muir Lisa Logan Mairiead MacLennan 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 International Journal of Infectious Diseases COVID-19 SARS-CoV-2 Diagnostic assay NeuMoDx RT-PCR Rapid testing |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | validation of the neumodx™ sars cov 2 assay with copan enat r and e o viral pcr sample solution collection media types in comparison with other validated sars cov 2 rna assays |
| topic | COVID-19 SARS-CoV-2 Diagnostic assay NeuMoDx RT-PCR Rapid testing |
| url | http://www.sciencedirect.com/science/article/pii/S1201971222004180 |
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