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

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.

Automated summary

This study aimed to evaluate the clinical performance of different automated immunoassays in Europe for detecting anti-SARS-CoV-2 antibodies and estimate the seroprevalence of SARS-CoV-2 antibodies among healthcare workers in Northern Greece. The results showed a high sensitivity and specificity of both CLIA and ELISA methods in confirmed COVID-19 patients.