Naslov
Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays

Autori
Tešija Kuna, Andrea ; Hanžek, Milena ; Vukasović, Ines ; Nikolac Gabaj, Nora ; Vidranski, Valentina ; Ćelap, Ivana ; Miler, Marijana ; Stančin, Nevenka ; Šimac, Brankica ; Živković, Marcela ; Žarak, Marko ; Kmet, Marta ; Jovanović, Marijana ; Tadinac, Sanja ; Šupraha Goreta, Sandra ; Periša, Josipa ; Šamija, Ivan ; Štefanović, Mario

Izvornik
Biochemia medica (1330-0962) 31 (2021), 1; 121-133

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
sensitivity ; specificity ; SARS-CoV-2 ; serological test

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA