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Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples.
- Source :
- American Journal of Clinical Pathology; Feb2021, Vol. 155 Issue 2, p267-279, 13p
- Publication Year :
- 2021
-
Abstract
- <bold>Objectives: </bold>Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has experienced a changing landscape of available assays coupled with uncertainty surrounding performance characteristics. Studies are needed to directly compare multiple commercially available assays.<bold>Methods: </bold>Residual serum samples were identified based on SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing, clinical test results, and collection dates. Serum samples were analyzed using assays from four different manufacturers: DiaSorin anti-SARS-CoV-2 S1/S2 IgG, EUROIMMUN anti-SARS-CoV-2 IgG ELISA, Roche Elecsys anti-SARS-CoV-2, and Siemens SARS-CoV-2 Total antibody assays.<bold>Results: </bold>Samples from SARS-CoV-2 RT-PCR-positive patients became increasingly positive as time from symptom onset increased. For patients with latest sample 14 or more days after symptom onset, sensitivities reached 93.1% to 96.6%, 98.3%, and 96.6% for EUROIMMUN, Roche, and Siemens assays, respectively, which were superior to the DiaSorin assay at 87.7%. The specificity of Roche and Siemens assays was 100% and superior to DiaSorin and EUROIMMUN assays, which ranged from 96.1% to 97.0% and 86.3% to 96.4%, respectively.<bold>Conclusions: </bold>Laboratories should be aware of the advantages and limitations of serology testing options for SARS-CoV-2. The specificity and sensitivity achieved by the Roche and Siemens assays would be acceptable for testing in lower-prevalence regions and have the potential of orthogonal testing advantages if used in combination. [ABSTRACT FROM AUTHOR]
- Subjects :
- SARS-CoV-2
REVERSE transcriptase polymerase chain reaction
Subjects
Details
- Language :
- English
- ISSN :
- 00029173
- Volume :
- 155
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- American Journal of Clinical Pathology
- Publication Type :
- Academic Journal
- Accession number :
- 148547971
- Full Text :
- https://doi.org/10.1093/ajcp/aqaa200