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
© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Journal of clinical laboratory analysis - 35(2021), 8 vom: 30. Aug., Seite e23906 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mueller, Thomas [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen |
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| Anmerkungen: |
Date Completed 30.08.2021 Date Revised 30.08.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/jcla.23906 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM327968672 |
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| 100 | 1 | |a Mueller, Thomas |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital |b Preliminary results from a single-center evaluation |
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| 500 | |a Date Revised 30.08.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Evaluation Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antigen | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a diagnostic test | |
| 650 | 4 | |a immunoassay | |
| 650 | 4 | |a laboratory medicine | |
| 650 | 4 | |a polymerase chain reaction | |
| 650 | 4 | |a virology | |
| 650 | 7 | |a Antigens, Viral |2 NLM | |
| 700 | 1 | |a Kompatscher, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a La Guardia, Mario |e verfasserin |4 aut | |
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