ArticleVaccines2022
Evaluation and Validation of the Roche Elecsys SARS-CoV-2 Antigen Electro-Chemiluminescent Immunoassay in a Southeast Asian Region.
Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled it
- Review
- Automated antigen assays display a high heterogeneity for the detection of SARS-CoV-2 variants of concern, including several Omicron sublineages.Medical microbiology and immunology · 2023Article
- SARS-CoV-2 Antigen Testing Intervals: Twice or Thrice a Week?Diagnostics (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSARS-CoV-2 antigen tests can complement and substitute for RT-PCR tests. Centralized laboratory automated SARS-CoV-2 antigen tests that can be scaled to process a large number COVID-19 cases simultaneously are now available. We have evaluated the new Roche Elecsys SARS-CoV-2 antigen electro-chemiluminescent immunoassay.
methodsThe Roche SARS-CoV-2 antigen assay is a double-antibody sandwich electro-chemiluminescent immunoassay, which reports a cut-off index (COI) (COI ≥ 1.0 considered positive). We assessed assay precision and linearity, and confirmed the reactivity limit. We determined the assay sensitivity and specificity with a verification group (289 controls and 61 RT-PCR positive COVID-19 cases). Assay performance was also validated against the consecutive samples we received (7657 controls and 17 cases) for SARS-CoV-2 antigen testing from June to October 2021.
resultThe assay had a within-run precision CV of 3.0% at COI 0.68, and a CV of 1.5% at COI 3.49. Between-run precision was 3.0% at COI 0.68 and 1.8% at COI 3.49. The assay was linear from COI 0.65 to 7.84. All 35 C
conclusionThe Elecsys SARS-CoV-2 antigen assay has good performance within manufacturer specifications. The sensitivity of the Roche antigen assay was greatest when used in patients with lower RT-PCR Ct values (≤30) and within the first week of disease onset.
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