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

• Published in: American journal of clinical pathology Vol. 155; no. 2; pp. 267 - 279
• Main Authors: Manthei, David M, Whalen, Jason F, Schroeder, Lee F, Sinay, Anthony M, Li, Shih-Hon, Valdez, Riccardo, Giacherio, Donald A, Gherasim, Carmen
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 01.02.2021
• Subjects: Antibodies, Viral - blood; Coronaviruses; COVID-19 - diagnosis; COVID-19 Serological Testing - methods; Electronic components industry; Enzyme-linked immunosorbent assay; Female; Health aspects; High-Throughput Screening Assays - methods; Humans; Immunoglobulin G; Male; Original; Patients; Polymerase chain reaction; Predictive Value of Tests; Reverse transcription; SARS-CoV-2 - immunology; Sensitivity and Specificity; Serology; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; United States; COVID-19; Immunoassay; SARS-CoV-2; Specificity; Sensitivity; Coronavirus; Serology
• ISSN: 0002-9173; 1943-7722; 1943-7722
• DOI: 10.1093/ajcp/aqaa200

Abstract 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.