ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses that pooled it.
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Who cites it
41 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2021Pooled it
- Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2020Pooled it
- FGL-1 plasma levels correlate with markers of inflammation and severe disease during SARS-CoV-2 infection.Communications medicine · 2026Article
- Frequency of IRF5+ dendritic cells is associated with the TLR7-induced inflammatory cytokine response in SARS-CoV-2 infection.Cytokine · 2023Article
- Evidence for broad cross-reactivity of the SARS-CoV-2 NSP12-directed CD4Frontiers in immunology · 2023Article
- Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants.Journal of medical virology · 2022Article
- Microfluidic affinity selection of active SARS-CoV-2 virus particles.Science advances · 2022Article
- Remdesivir-induced emergence of SARS-CoV2 variants in patients with prolonged infection.Cell reports. Medicine · 2022Article
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- Virus MIP-composites for SARS-CoV-2 detection in the aquatic environment.Materials letters · 2022Article
- Challenges of oral medicine specialists at the time of COVID-19 pandemic.Oral diseases · 2022Article
- SARS-CoV-2 Diagnostics Based on Nucleic Acids Amplification: From Fundamental Concepts to Applications and Beyond.Frontiers in cellular and infection microbiology · 2022Review
- High-resolution analysis of individual spike peptide-specific CD4Clinical & translational immunology · 2022Article
- Machine learning approaches in Covid-19 severity risk prediction in Morocco.Journal of big data · 2022Article
- Article
- SARS-CoV-2 Blood RNA Load Predicts Outcome in Critically Ill COVID-19 Patients.Open forum infectious diseases · 2021Article
- Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study.Diagnostics (Basel, Switzerland) · 2021Article
- The handling of SARS-CoV-2 associated deaths - infectivity of the body.Forensic science, medicine, and pathology · 2021Article
- Article
- Cross-disciplinary approaches to assist with nucleic acid testing for SARS-CoV-2.Applied microbiology and biotechnology · 2021Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe ongoing SARS-CoV-2 pandemic presents a unique challenge for diagnostic laboratories around the world. Automation of workflows in molecular diagnostics is instrumental for coping with the large number of tests ordered by clinicians, as well as providing fast-tracked rapid testing for highly urgent cases. In this study we evaluated a SARS-CoV-2 LDT for the NeuMoDx 96 system, a fully automated device performing extraction and real-time PCR.
methodsA publicly available SARS-CoV-2 RT-PCR assay was adapted for the automated system. Analytical performance was evaluated using in-vitro transcribed RNA and clinical performance was compared to the cobas 6800-based reference assay within the lab.
resultsThe Envelope (E) Gene-LDT displayed good analytical performance with an LoD of 95.55 cp/mL and no false positives during evaluation of cross-reactivity. A total of 176 patient samples were tested with both the E-Gene-LDT and the reference assay. Positive and negative agreement were 100 % and 99.2 % respectively. Invalid-rate was 6.3 %.
conclusionThe E-Gene-LDT showed analytical and clinical performance comparable to the cobas6800-based reference assay. Due to its random-access workflow concept and rapid time-to-result of about 80 min, the system is very well suited for providing fast-tracked SARS-CoV-2 diagnostics for urgent clinical samples in the hospital setting.
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