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. 2021 Jan 15;59(6):1143-1154.
doi: 10.1515/cclm-2020-1758. Print 2021 May 26.

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

Christian Irsara  1 , Alexander E Egger  1 , Wolfgang Prokop  1 , Manfred Nairz  2 , Lorin Loacker  1 , Sabina Sahanic  2 , Alex Pizzini  2 , Thomas Sonnweber  2 , Wolfgang Mayer  3 , Harald Schennach  3 , Judith Loeffler-Ragg  2 , Rosa Bellmann-Weiler  2 , Ivan Tancevski  2 , Günter Weiss  2 , Markus Anliker  1 , Andrea Griesmacher  1 , Gregor Hoermann  1   4
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Free article

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

Christian Irsara et al. Clin Chem Lab Med. .
Free article

Abstract

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.

Keywords: COVID-19; SARS-CoV-2 antibody; orthogonal testing; sensitivity; serologic tests; specificity.

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