tetano
Editor, Senior Moderator
Am J Clin Pathol
. 2020 Oct 9;aqaa200.
doi: 10.1093/ajcp/aqaa200. Online ahead of print.
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
David M Manthei[SUP] 1 [/SUP], Jason F Whalen[SUP] 1 [/SUP], Lee F Schroeder[SUP] 1 [/SUP], Anthony M Sinay[SUP] 1 [/SUP], Shih-Hon Li[SUP] 1 [/SUP], Riccardo Valdez[SUP] 1 [/SUP], Donald A Giacherio[SUP] 1 [/SUP], Carmen Gherasim[SUP] 1 [/SUP]
Affiliations
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.
Keywords: COVID-19; Coronavirus; Immunoassay; SARS-CoV-2; Sensitivity; Serology; Specificity.
. 2020 Oct 9;aqaa200.
doi: 10.1093/ajcp/aqaa200. Online ahead of print.
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
David M Manthei[SUP] 1 [/SUP], Jason F Whalen[SUP] 1 [/SUP], Lee F Schroeder[SUP] 1 [/SUP], Anthony M Sinay[SUP] 1 [/SUP], Shih-Hon Li[SUP] 1 [/SUP], Riccardo Valdez[SUP] 1 [/SUP], Donald A Giacherio[SUP] 1 [/SUP], Carmen Gherasim[SUP] 1 [/SUP]
Affiliations
- PMID: 33033840
- 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.
Keywords: COVID-19; Coronavirus; Immunoassay; SARS-CoV-2; Sensitivity; Serology; Specificity.