Theocharis Konstantinidis1, Stavroula Zisaki2, Ioannis Mitroulis3, Dimitrios Cassimos4, Ioanna Nanousi2, Eftychia G Kontekaki5, Vasilis Petrakis6, Kalliopi Parrisi7, Eleni Fotiadou8, Aikaterini Linardou7, Nikolaos Lemonakis9, Anastasia Grapsa10, Theodora Gioka10, Leonidas Lazidis5, Charalampos Papagoras11, Chistina Tsigalou12, Periklis Panagopoulos13, Panagiotis Skendros11, Georges Martinis5, Maria Panopoulou14. 1. MD, PhD, Blood Transfusion Center, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece, Laboratory of Microbiology, Democritus University of Thrace, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 2. MSc, Blood Transfusion Center, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 3. MD, PhD, First Department of Internal Medicine, Democritus University of Thrace, Dragana Campus, 68100 Alexandroupolis, Greece. 4. MD, PhD, Pediatric Department, Democritus University of Thrace, Dragana Campus, 68100 Alexandroupolis, Greece, Alexandroupolis. 5. MD, Blood Transfusion Center, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 6. MD, Second Department of Internal Medicine, Democritus University of Thrace, Dragana Campus, 68100 Alexandroupolis, Greece, Alexandroupolis. 7. Ms, Blood Transfusion Center, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 8. Ms, Laboratory of Microbiology, Democritus University of Thrace, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 9. MSs, Laboratory of Microbiology, Democritus University of Thrace, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 10. MD, Laboratory of Microbiology, Democritus University of Thrace, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 11. MD, PhD, First Department of Internal Medicine, Democritus University of Thrace, Dragana Campus, 68100 Alexandroupolis, Greece, Alexandroupolis. 12. MD, PhD, Laboratory of Microbiology, Democritus University of Thrace, University General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece. 13. MD, PhD, Second Department of Internal Medicine, Democritus University of Thrace, Dragana Campus, 68100 Alexandroupolis, Greece, Alexandroupolis. 14. MD, PhD, Laboratory of Microbiology, Democritus University of Thrace, Universit y General Hospital of Alexandroupolis Dragana Campus, 68100 Alexandroupolis, Greece.
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. GERMS.
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. GERMS.
Entities:
Keywords:
COVID-19; RT-PCR; SARS-CoV-2; anti-SARS-CoV-2 antibodies; diagnosis; global health problem
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