ArticleJournal of clinical laboratory analysis2021
Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single-center evaluation.
Article in Journal of clinical laboratory analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Association Between Rapid Antigen Detection Tests and Real-Time Reverse Transcription-Polymerase Chain Reaction Assay for SARS-CoV-2: A Systematic Review and Meta-Analyses.International journal of public health · 2023Pooled it
- Interpretation of Positive Roche Elecsys SARS-CoV-2 Antigen Test Results: Value for Clinical Decisions.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025Article
- Severe acute respiratory syndrome coronavirus 2 antibody prevalence in adult patients with short bowel syndrome-A German multicenter cross-sectional study.JPEN. Journal of parenteral and enteral nutrition · 2022Article
- Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single-center evaluation.Journal of clinical laboratory analysis · 2021Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis report describes a manufacturer-independent evaluation of the diagnostic accuracy of the Elecsys SARS-CoV-2 antigen assay from Roche Diagnostics in a tertiary care setting.
methodsIn this single-center study, we used nasopharyngeal swabs from 403 cases from the emergency department and intensive care unit of our hospital. The reference standard for detecting SARS-CoV-2 was the reverse-transcription polymerase chain reaction (RT-PCR) assay. Cycle threshold (Ct) values were recorded for positive RT-PCR assays. The index test was the Elecsys SARS-CoV-2 antigen assay. This electrochemiluminescence immunoassay produces results as cutoff index (COI) values, with values ≥1.00 being reported as positive.
resultsOf the 403 cases, 47 showed positive results in RT-PCR assays. Of the 47 RT-PCR-positive cases, 12 showed positive results in the antigen assay. Of the 356 RT-PCR-negative cases, all showed negative results in the antigen assay. Thus, the antigen assay showed a sensitivity of 26% (95% CI, 14%-40%) and specificity of 100% (95% CI, 99%-100%). Analysis of the relationship between Ct values and COI values in the 47 RT-PCR-positive cases showed a correlation coefficient of -0.704 (95% CI, -0.824 to -0.522). The true-positive rate of the antigen assay for Ct values of 15-24.9, 25-29.9, 30-34.9, and 35-39.9 was 100%, 44%, 8%, and 6%, respectively.
conclusionsThe Elecsys SARS-CoV-2 antigen assay has a low sensitivity for detecting SARS-CoV-2 from nasopharyngeal swabs. Hence, we decided to not use this assay in the clinical routine of our hospital.
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