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Evaluation of three fully-automated SARS-CoV-2 antibody assays
- Source :
- Clinical Chemistry and Laboratory Medicine (CCLM). 58:2113-2120
- Publication Year :
- 2020
- Publisher :
- Walter de Gruyter GmbH, 2020.
-
Abstract
- Objectives Serological assays for detection of SARS-CoV-2 antibodies are increasingly used during the COVID-19 pandemic caused by the SARS-Coronavirus-2. Here we evaluated the analytical and clinical performance of three commercially available SARS-CoV-2 antibody assays. Methods A total of 186 samples from 58 patients with PCR-confirmed COVID-19 infection were measured using SARS-CoV-2 antibody assays by Siemens Healthineers, Roche Diagnostics and Euroimmun. Additionally, 123 control samples, including samples collected before December 2019 and samples with potential cross-reactive antibodies were analyzed. Diagnostic specificity, sensitivity, agreement between assays and ROC curve-derived optimized thresholds were determined. Furthermore, intra- and inter-assay precision and the potential impact of interfering substances were investigated. Results SARS-CoV-2 antibody assays by Siemens and Roche showed 100% specificity. The Euroimmun assay had 98 and 100% specificity, when borderline results are considered as positive or negative, respectively. Diagnostic sensitivity for samples collected ≥14 days after PCR-positivity was 97.0, 89.4 and 95.5% using the Siemens, Roche and Euroimmun assay, respectively. Sensitivity of the Roche assay can be increased using an optimized cut-off index (0.095). However, a simultaneous decrease in specificity (98.4%) was observed. Siemens showed 95.8 and 95.5% overall agreement with results of Euroimmun and Roche assay, respectively. Euroimmun and Roche assay exhibited 92.6% overall agreement. Discordant results were observed in three COVID-19 patients and in one COVID-19 patient none of the investigated assays detected antibodies. Conclusions The investigated assays were highly specific and sensitive in detecting SARS-CoV-2 antibodies in samples obtained ≥14 days after PCR-confirmed infection. Discordant results need to be investigated in further studies.
- Subjects :
- 0301 basic medicine
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Clinical Biochemistry
030204 cardiovascular system & hematology
Antibodies, Viral
Roche Diagnostics
Serology
Automation
Betacoronavirus
03 medical and health sciences
0302 clinical medicine
Humans
Medicine
Serologic Tests
Potential impact
biology
SARS-CoV-2
business.industry
Biochemistry (medical)
Clinical performance
General Medicine
Molecular biology
030104 developmental biology
ROC Curve
Fully automated
biology.protein
Antibody
business
Subjects
Details
- ISSN :
- 14374331 and 14346621
- Volume :
- 58
- Database :
- OpenAIRE
- Journal :
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Accession number :
- edsair.doi.dedup.....8b3ed50e605b38f47dce4b7eca9c2f9e