ArticleJournal of clinical medicine2022
Comparative Diagnostic Accuracy of the STANDARD M10 Assay for the Molecular Diagnosis of SARS-CoV-2 in the Point-of-Care and Critical Care Settings.
Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
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Who cites it
8 citing papers in PubMed, 11 citations in OpenAlex.
- Molecular Point-of-Care Testing for Respiratory Infections: A Comprehensive Literature Review (2006-2026).Diagnostics (Basel, Switzerland) · 2026Review
- Evaluation of analytical performance of the STANDARDEmerging microbes & infections · 2024Article
- Evaluation of the STANDARD M10 MDR-TB and MTB/NTM assays for the detection ofJournal of clinical microbiology · 2024Article
- Diagnostic Accuracy of Five Molecular Assays for the Detection of Dengue Virus.Medicina (Kaunas, Lithuania) · 2024Article
- Rapid RT-PCR identification of SARS-CoV-2 in screening donors of fecal microbiota transplantation.Heliyon · 2023Article
- Evaluation of STANDARDJournal of clinical virology plus · 2023Article
- High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2.Biomedicines · 2022Article
- Performance evaluation of a new on-demand molecular test for the rapid identification of severe acute respiratory syndrome coronavirus 2 in pediatric and adult patients.Frontiers in microbiology · 2022Article
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
Accurate and rapid molecular diagnosis of COVID-19 is a crucial step to tackle the ongoing pandemic. The primary objective of this study was to estimate the real-world performance of the novel RT-PCR STANDARD M10 SARS-CoV-2 assay in a large number of nasopharyngeal (NP) specimens eluted in universal transport medium. The secondary objective was to evaluate the compatibility of this kit in testing NP samples eluted in an inactivated transport medium (essential for point-of-care testing) and lower respiratory tract (LRT) specimens, which are commonly collected in critical care. A total of 591 samples were analyzed. Compared with the standard extraction-based RT-PCR Allplex 2019-nCoV (time-to-result of 270 min), the sensitivities of the STANDARD M10 were 100% (95% CI: 98.1-100%), 95.5% (95% CI: 91.7-97.6%), and 99.5% (95% CI: 97.2-99.9%) for ≥1 gene, the ORF1ab gene, and the E gene, respectively, while the specificity was 100% (95% CI: 98.7-100%). The diagnostic accuracy was 100% in testing both NP samples eluted in an inactivated transport medium and LRT specimens. STANDARD M10 reliably detects SARS-CoV-2 in 60 min, may be used as a POC tool, and is suitable for testing LRT specimens in the critical care setting.
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Registered trials
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