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
| Autor: | Lee F. Schroeder, David M Manthei, Anthony M Sinay, Donald A. Giacherio, Riccardo Valdez, Jason F Whalen, Shih-Hon Li, Carmen Gherasim |
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| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030106 microbiology Siemens Antibodies Viral Sensitivity and Specificity COVID-19 Serological Testing Serology 03 medical and health sciences Sensitivity 0302 clinical medicine Predictive Value of Tests High-Throughput Screening Assays medicine Humans 030212 general & internal medicine Symptom onset Igg elisa Immunoassay medicine.diagnostic_test biology SARS-CoV-2 business.industry COVID-19 General Medicine Virology Coronavirus Specificity biology.protein Female Original Article Antibody business AcademicSubjects/MED00690 |
| Zdroj: | American Journal of Clinical Pathology |
| ISSN: | 1943-7722 0002-9173 |
| DOI: | 10.1093/ajcp/aqaa200 |
| Popis: | Objectives 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. Methods 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. Results 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. Conclusions 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. |
| Databáze: | OpenAIRE |
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