ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Comparison of the analytical sensitivity of seven commonly used commercial SARS-CoV-2 automated molecular assays.
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 60 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
60 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.
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- Simulated High Throughput Sequencing Datasets: A Crucial Tool for Validating Bioinformatic Pathogen Detection Pipelines.Biology · 2024Article
- At-home testing for respiratory viruses: a minireview of the current landscape.Journal of clinical microbiology · 2024Review
- Rapid Detection of SARS-CoV-2 Based on the LAMP Assay Associated with the CRISPRCas12a System.Diagnostics (Basel, Switzerland) · 2023Article
- Diagnostics and analysis of SARS-CoV-2: current status, recent advances, challenges and perspectives.Chemical science · 2023Review
- Evaluation of SARS-CoV-2 Detection Systems Using Clinical Samples and Standard Material: A Comparative Study.Diagnostics (Basel, Switzerland) · 2023Article
- Comparison between Nasopharyngeal and Saliva Samples for the Detection of Respiratory Viruses in Children with Acute Lower Respiratory Tract Infections: A Pilot Study.Children (Basel, Switzerland) · 2023Article
- Omicron Subvariants: Clinical, Laboratory, and Cell Culture Characterization.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol.Virology journal · 2023Article
- Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future.Critical reviews in clinical laboratory sciences · 2022Review
- SARS-CoV-2 reinfections during the Delta and Omicron waves.JCI insight · 2022Article
- Omicron Subvariants: Clinical, Laboratory, and Cell Culture Characterization.medRxiv : the preprint server for health sciences · 2022Article
- Infection With the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Delta Variant Is Associated With Higher Recovery of Infectious Virus Compared to the Alpha Variant in Both Unvaccinated and Vaccinated Individuals.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Exploring beyond the limit: How comparative stochastic performance affects retesting outcomes in six commercial SARS CoV-2 nucleic acid amplification tests.Journal of clinical virology plus · 2022Article
- SARS-CoV-2 infections in mRNA vaccinated individuals are biased for viruses encoding spike E484K and associated with reduced infectious virus loads that correlate with respiratory antiviral IgG levels.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022Article
- An Overview of SARS-CoV-2 Molecular Diagnostics in Europe.Clinics in laboratory medicine · 2022Review
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
The SARS-CoV-2 pandemic has challenged molecular microbiology laboratories to quickly implement and validate diagnostic assays and to expand testing capacity in a short timeframe. Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. Several studies reported the analytical and/ or clinical evaluation of these molecular assays, however differences in the viral materials used for these evaluations complicated direct comparison of their analytical performance. In this study, we compared the analytical sensitivity (lower limit of detection, LOD) of seven commonly used qualitative SARS-CoV-2 molecular assays: the Abbott Molecular RealTime SARS-CoV-2 assay, the NeuMoDx™ SARS-CoV-2 assay, the Roche Cobas®SARS-CoV-2 assay, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2 assay, the Xpert Xpress SARS-CoV-2 test, and the GenMark ePlex SARS-CoV-2 test. The comparison was performed utilizing a single positive clinical specimen that was serially diluted in viral transport media and quantified by the EUA approved SARS-CoV-2 droplet digital PCR (ddPCR) assay. Replicate samples were prepared and evaluated for reproducibility across different molecular assays with multiple replicates per assay. Our data demonstrated that the seven assays could detect 100 % of replicates at a nucleocapsid gene concentration of (N1 = 1,267 and N2 = 1,392) copies/mL. At a one log less concentration, the Abbott, the Roche, and the Xpert Xpress assays detected 100 % of the tested replicates.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.