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Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays.
Tesija Kuna, Andrea; Hanzek, Milena; Vukasovic, Ines; Nikolac Gabaj, Nora; Vidranski, Valentina; Celap, Ivana; Miler, Marijana; Stancin, Nevenka; Simac, Brankica; Zivkovic, Marcela; Zarak, Marko; Kmet, Marta; Jovanovic, Marijana; Tadinac, Sanja; Supraha Goreta, Sandra; Perisa, Josipa; Samija, Ivan; Stefanovic, Mario.
  • Tesija Kuna A; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Hanzek M; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Vukasovic I; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Nikolac Gabaj N; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Vidranski V; Department of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Celap I; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Miler M; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Stancin N; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Simac B; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Zivkovic M; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Zarak M; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Kmet M; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Jovanovic M; Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia.
  • Tadinac S; Department of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Supraha Goreta S; Department of Biochemistry and Molecular Biology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.
  • Perisa J; Department of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Samija I; Department of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
  • Stefanovic M; Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.
Biochem Med (Zagreb) ; 31(1): 010708, 2021 Feb 15.
Article in English | MEDLINE | ID: covidwho-1273682
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Testing / COVID-19 Type of study: Diagnostic study / Observational study Limits: Humans Language: English Journal: Biochem Med (Zagreb) Year: 2021 Document Type: Article Affiliation country: Bm.2021.010708

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Testing / COVID-19 Type of study: Diagnostic study / Observational study Limits: Humans Language: English Journal: Biochem Med (Zagreb) Year: 2021 Document Type: Article Affiliation country: Bm.2021.010708