Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays
| Autor: | Marta Kmet, Nora Nikolac Gabaj, Sandra Šupraha Goreta, Milena Hanžek, Marcela Živković, Andrea Tešija Kuna, Ivan Šamija, Marijana Jovanović, Josipa Periša, Marko Žarak, Mario Štefanović, Nevenka Stančin, Sanja Tadinac, Marijana Miler, Brankica Šimac, Valentina Vidranski, Ivana Ćelap, Ines Vukasović |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
030213 general clinical medicine
medicine.medical_specialty Clinical Biochemistry Population specificity Gastroenterology Asymptomatic Sensitivity and Specificity Virus law.invention Serology 03 medical and health sciences 0302 clinical medicine COVID-19 Testing law Internal medicine Medicine Seroprevalence Humans Serologic Tests education Polymerase chain reaction 030304 developmental biology 0303 health sciences education.field_of_study biology business.industry SARS-CoV-2 sensitivity serological test Biochemistry (medical) COVID-19 Original Articles biology.protein medicine.symptom Antibody business Kappa |
| Zdroj: | Biochemia Medica Volume 31 Issue 1 |
| ISSN: | 1846-7482 1330-0962 |
| Popis: | Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests have been suggested as an additional diagnostic tool in highly suspected cases with a negative molecular test and determination of seroprevalence in population. We compared the diagnostic performance of eight commercial serological assays for IgA, IgM, and IgG antibodies to the SARS-CoV-2 virus. Materials and methods: The comparison study was performed on a total of 76 serum samples: 30 SARS-CoV-2 polymerase chain reaction (PCR)- negative and 46 SARS-CoV-2 PCR-positive patients with asymptomatic to severe disease and symptoms duration from 3-30 days. The study included: three rapid lateral flow immunochromatographic assays (LFIC), two enzyme-linked immunosorbent assays (ELISA), and three chemiluminescence immunoassays (CLIA). Results: Agreement between IgM assays were minimal to moderate (kappa 0.26 to 0.63) and for IgG moderate to excellent (kappa 0.72 to 0.92). Sensitivities improved with > 10 days of symptoms and were: 30% to 89% for IgM; 89% to 100% for IgG; 96% for IgA; 100% for IgA/IgM combination; 96% for total antibodies. Overall specificities were: 90% to 100% for IgM; 85% to 100% for IgG; 90% for IgA; 70% for IgA/IgM combination; 100% for total antibodies. Diagnostic accuracy for IgG ELISA and CIA assays were excellent (AUC ≥ 0.90), without significant difference. IgA showed significantly better diagnostic accuracy than IgM (P < 0.001). Conclusion: There is high variability between IgM assays independently of the assay format, while IgG assays showed moderate to perfect agreement. The appropriate time for testing is crucial for the proper immunity investigation. |
| Databáze: | OpenAIRE |
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