ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2021
Evaluation of the Elecsys SARS-CoV-2 antigen assay for the detection of SARS-CoV-2 in nasopharyngeal swabs.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled it
- A method comparison study of the high throughput automated HISCL® SARS-CoV-2 antigen assay using nasopharyngeal swab samples from symptomatic and asymptomatic subjects against conventional RT-PCR.Journal of medical virology · 2022Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe aim of this study was to evaluate the performance of the automated Elecsys® SARS-CoV-2 antigen assay compared to RT-PCR taken as the gold standard for SARS-CoV-2 detection.
methods225 nasopharyngeal swabs were randomly collected among which 123 were tested positive and 102 negatives for SARS-CoV-2 based on RT-PCR. Antigen dosing were performed on a Cobas 8000 e801 analyzer.
resultsThe antigen test diagnosed SARS-CoV-2 infection status with an overall sensitivity of 65,85% (95% CI 56,76-74,16%), a specificity of 100% (95% CI 96,49-100%) with a Cut-off value ≥ 1. When the cut-off value for the antigen assay was set to > 0,673 COI, the accuracy reached its highest level with a sensitivity of 74,8% (95% CI 66,2 - 82,2%) and a specificity of 97,1% (95% CI 91,6 - 99,4%). Imprecision was estimated in accordance with manufacturer's claims.
conclusionsWe obtained an overall sensitivity of 65,85% (95% CI 56,76-74,16%) and a specificity of 100% (95% CI 96,49-100%), slightly higher than the results reported by the manufacturer. Yet, it remains relatively low comparatively to what is generally acceptable for these antigenic assays (a relative sensitivity of 80%). We also noticed that the accuracy could reach its highest level if the cut-off is set above 0,673 which is lower than established by the manufacturer. Thus, our results suggest that the Elecsys® SARS-CoV-2 Antigen assays, should be improved prior to be used in a SARS-Cov-2 screening strategy. However, if one antigenic assay could demonstrate acceptable performance, it might be centralized in clinical laboratories, keeping the RT-PCR in a second phase for confirmation.
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