Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay

Objectives: Serological tests detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the ongoing coronavirus disease-19 (COVID-19) pandemic. Independent external clinical validation of performance characteristics is of paramount importance. Methods: Four fully automated assays, Roche Elecsys Anti-SARS-CoV-2, Abbott SARS-CoV-2 IgG, Siemens SARS-CoV-2 total (COV2T) and SARS-CoV-2 IgG (COV2G) were evaluated using 350 pre-pandemic samples and 700 samples from 245 COVID-19 patients (158 hospitalized, 87 outpatients). Results: All tests showed very high diagnostic specificity. Sensitivities in samples collected at least 14 days after disease onset were slightly lower than manufacturers’ claims for Roche (93.0%), Abbott (90.8%), and Siemens COV2T (90.3%), and distinctly lower for Siemens COV2G (78.8%). Concordantly negative results were enriched for immunocompromised patients. ROC curve analyses suggest a lowering of the cut-off index for the Siemens COV2G assay. Finally, the combination of two anti-SARS-CoV-2 antibody assays is feasible when considering borderline reactive results. Conclusions: Thorough on-site evaluation of commercially available serologic tests for detection of antibodies against SARS-CoV-2 remains imperative for laboratories. The potentially impaired sensitivity of the Siemens COV2G necessitates a switch to the company’s newly filed SARS-CoV-2 IgG assay for follow-up studies. A combination of tests could be considered in clinical practice.

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch

References and Relationships

• Bibliographic citation: Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay ; volume:59 ; number:6 ; year:2021 ; pages:1143-1154 ; extent:12 ; Clinical chemistry and laboratory medicine ; 59, Heft 6 (2021), 1143-1154 (gesamt 12)

Contributors, Places and Time

• Creator: Irsara, Christian ; Egger, Alexander E. ; Prokop, Wolfgang ; Nairz, Manfred ; Loacker, Lorin ; Sahanic, Sabina ; Pizzini, Alex ; Sonnweber, Thomas ; Mayer, Wolfgang ; Schennach, Harald ; Loeffler-Ragg, Judith ; Bellmann-Weiler, Rosa ; Tancevski, Ivan ; Weiss, Günter ; Anliker, Markus ; Griesmacher, Andrea ; Hoermann, Gregor

Further information

• DOI: 10.1515/cclm-2020-1758
• URN: urn:nbn:de:101:1-2022061217215211051973
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:26 AM CEST