Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: ©Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2021, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 27 August 2020
Date accepted: 23 November 2020
Publication date (print and electronic): 15 February 2021
Volume: 31
Issue: 1
Electronic Location Identifier: 010708
Publisher ID: bm-31-1-010708
DOI: 10.11613/BM.2021.010708
Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays
Milena Hanžek[1]
Ines Vukasović[1]
Nora Nikolac Gabaj[1]
Valentina Vidranski[2]
Ivana Ćelap[1]
Marijana Miler[1]
Nevenka Stančin[3]
Brankica Šimac[3]
Marcela Živković[3]
Marko Žarak[3]
Marta Kmet[3]
Marijana Jovanović[3]
Sanja Tadinac[2]
Sandra Šupraha Goreta[4]
Josipa Periša[2]
Ivan Šamija[2]
Mario Štefanović[1]
[1] Department of Clinical Chemistry, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
[2] Department of Oncology and Nuclear Medicine, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
[3] Clinical Department of Laboratory Diagnostics, University Hospital Dubrava, Zagreb, Croatia
[4] Department of Biochemistry and Molecular Biology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia
Author notes:
[*] Corresponding author: andrea.kuna@gmail.com
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).
Keywords: sensitivity; specificity; SARS-CoV-2; serological test
