ArticleJournal of medical virology2022
Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19.
Article in Journal of medical virology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.
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Who cites it
5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Guideline
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled 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
- Performance of an interferon-γ release assay-based test for cell-mediated immunity to SARS-CoV-2.Frontiers in immunology · 2023Article
- Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19.Journal of medical virology · 2022Article
Corrections and comments
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Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
One of the challenges for control and prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the early diagnostic at the point of care. Several tests based on qualitative antigen detection have been developed; one of these is Elecsys SARS-CoV-2 Antigen immunoassay (Roche Diagnostics). In total, 523 nasopharyngeal swabs were randomly selected with the aims to evaluate sensitivity, specificity, cross-reactivity, positive and negative predictive value (PPV, NPV), and agreement of Elecsys SARS-CoV-2 Antigen immunoassay using reverse transcription-polymerase chain reaction (RT-PCR) STAT-NAT® coronavirus disease-2019 as reference test. Cross-reactivity was estimated using samples positive by RT-PCR to other respiratory viruses (influenza virus, parainfluenza virus, rhinovirus, coronavirus OC43, and HKU1). The overall sensitivity of Elecsys SARS-CoV-2 Antigen was 89.72% (288/321); specificity was 90.59% (183/202); and cross-reactivity to other respiratory viruses were not detected. Elecsys SARS-CoV-2 Antigen immunoassay showed a high sensitivity in samples with cycle threshold value <30, which ranged from 92.81% to 95.40%, independently of symptoms. PPV and NPV were 93.81% and 84.72%, respectively. The κ coefficient was 0.79 (95% confidence interval: 0.73-0.84), showing substantial agreement between both tests. The results suggest Elecsys SARS-CoV-2 Antigen immunoassay could be used as an alternative to RT-PCR testing, or in complement with it, to identify infectious individuals and reduce SARS-CoV-2 transmission.
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