Article ; Online: 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
2021 Volume 35, Issue 8, Page(s) e23906
Abstract: ... of the Elecsys SARS-CoV-2 antigen assay from Roche Diagnostics in a tertiary care setting.: Methods ... assays. The index test was the Elecsys SARS-CoV-2 antigen assay. This electrochemiluminescence ... 39.9 was 100%, 44%, 8%, and 6%, respectively.: Conclusions: The Elecsys SARS-CoV-2 antigen assay ...
| Abstract | Background: This 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. Methods: In 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. Results: Of 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. Conclusions: The 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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| MeSH term(s) | Antigens, Viral/analysis ; COVID-19/diagnosis ; COVID-19/virology ; COVID-19 Nucleic Acid Testing ; COVID-19 Serological Testing/methods ; Humans ; Intensive Care Units ; Nasopharynx/virology ; SARS-CoV-2/immunology ; Sensitivity and Specificity ; Tertiary Care Centers ; Viral Load | |||||
| Chemical Substances | Antigens, Viral | |||||
| Language | English | |||||
| Publishing date | 2021-07-12 | |||||
| Publishing country | United States | |||||
| Document type | Evaluation Study ; Journal Article | |||||
| ZDB-ID | 645095-7 | |||||
| ISSN | 1098-2825 ; 0887-8013 | |||||
| ISSN (online) | 1098-2825 | |||||
| ISSN | 0887-8013 | |||||
| DOI | 10.1002/jcla.23906 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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