Prevalence of anti-SARS-CoV-2 IgG antibodies in a group of patients, a control group, and healthcare workers of Thrace area in Greece, by the use of two distinct methods

Germs. 2021 Sep 29;11(3):372-380. doi: 10.18683/germs.2021.1274. eCollection 2021 Sep.

Abstract

Introduction: The aim of this study was to assess the clinical performance of different automated immunoassays available in Europe to detect anti-SARS-CoV-2 antibodies; an ELISA assay and a CLIA. The second goal was to estimate the seroprevalence of SARS-CoV-2 antibodies among healthcare workers in Evros area during the first pandemic wave of COVID-19.

Methods: The study included serum samples from 101 patients with confirmed COVID-19 by RT-PCR and 208 negative patients. Furthermore, it included 1036 healthcare workers (HWs) of the Evros Region, Northern Greece. The measurement of anti-SARS-CoV-2 antibodies was performed using the Abbott SARS-CoV-2 IgG and anti-SARS-CoV-2 ELISA IgG assay (Epitope Diagnostics, USA).

Results: Of 101 confirmed COVID-19 patients, 82 were hospitalized and 19 were outpatients. Hospitalized patients had higher IgG levels in comparison to outpatients (6.46±2.2 vs. 3.52±1.52, p<0.001). Of 208 non-COVID-19 patients only 1 was positive in both ELISA and CLIA assay. SARS-CoV-2-IgG antibodies were detected in 6 HWs out of 1036 (0.58%) with mean S/CO-value of anti-SARS-CoV-2 IgG 3.12±1.3 (confidence interval 0.95), which was lower than in COVID-19 patients (3.12 vs. 5.9; p=0.016). The clinical evaluation of two immunoassays showed remarkably high true positivity rates in the confirmed COVID-19 patients. Sensitivities obtained with CLIA and ELISA methods were 99.02% vs. 97.09% and specificities 99.52% vs 99.05% respectively.

Conclusions: We found an acceptable accordance between CLIA and ELISA assays in the confirmed COVID-19 patients. In all subjects included in this study in the past medical history, the information that was obtained included details about the presence of autoimmune diseases.

Keywords: COVID-19; RT-PCR; SARS-CoV-2; anti-SARS-CoV-2 antibodies; diagnosis; global health problem.