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. 2020 Oct 13;154(5):620-626.
doi: 10.1093/ajcp/aqaa155.

Analytical and Clinical Evaluation of the Automated Elecsys Anti-SARS-CoV-2 Antibody Assay on the Roche cobas e602 Analyzer

Clarence W Chan  1 , Kyle Parker  1 , Vera Tesic  1   2 , Angel Baldwin  3 , Nga Yeung Tang  1 , Xander M R van Wijk  1   2 , Kiang-Teck J Yeo  1   2
Affiliations

Analytical and Clinical Evaluation of the Automated Elecsys Anti-SARS-CoV-2 Antibody Assay on the Roche cobas e602 Analyzer

Clarence W Chan et al. Am J Clin Pathol. .

Abstract

Objectives: To evaluate the analytical and clinical performance of the automated Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody (Elecsys Ab) assay on the Roche cobas e602 analyzer. With the ongoing global coronavirus disease 2019 (COVID-19) pandemic, widespread and routine serologic testing of SARS-CoV-2 remains a pressing need. To better understand its epidemiologic spread and to support policies aimed at curtailing further infections, reliable serologic testing is crucial for providing insight into the dynamics of the spread of COVID-19 on a population level.

Methods: The presence of anti-SARS-CoV-2 antibodies in polymerase chain reaction-positive, confirmed COVID-19 patient samples was determined using the Elecsys Ab assay on the Roche cobas e602 analyzer. The precision and cross-reactivity of the Elecsys Ab assay were characterized and its performance was compared against the EuroImmun IgA/IgG antibody (EuroImmun Ab) assay. Calculated sensitivity, specificity, and positive and negative predictive values were assessed.

Results: The Elecsys Ab assay demonstrated good precision, had no cross-reactivity with other viral samples, and showed 100% concordance with the EuroImmun Ab assay. Excellent clinical performance with respect to sensitivity, specificity, and positive and negative predictive values was observed.

Conclusions: The Elecsys Ab assay is a precise and highly reliable automated platform for clinical detection of seropositivity in SARS-CoV-2 infection.

Keywords: COVID-19; Coronavirus; Diagnostics; IgA; IgG; IgM; Immunoassay; SAR-CoV-2 antibodies; Serology; Surveillance.

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Figures

Figure 1
Figure 1
Method comparison of the EuroImmun vs Elecsys anti–severe acute respiratory syndrome coronavirus 2 antibody (Ab) assays. A total of 66 polymerase chain reaction (PCR)–confirmed patient samples were compared, resulting in zero discrepancies and an overall concordance rate of 100%. Reactive (+) and nonreactive (–) Elecsys Ab assay results are defined by a cutoff index (COI) of 1.0 or more or less than 1.0, respectively. Of the 40 (+) EuroImmun Ab assay samples, 36 were positive for both immunoglobulin A (IgA) and immunoglobulin G (IgG) and 4 were positive for only IgG. All 20 (–) EuroImmun Ab assay samples were negative for both IgA and IgG.
Figure 2
Figure 2
Cross-reactivity with other viral positive samples. A total of 20 human immunodeficiency virus (HIV) (A), 15 hepatitis B surface antigen (HepBS) (B), and 17 hepatitis C (HCV) (C) antibody (Ab)–positive samples were assayed. Reactive (+) and nonreactive (–) Elecsys Ab assay results are defined by a cutoff index (COI) of 1.0 or more or less than 1.0, respectively.
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