Tweet
J Med Virol. 2020 Apr 24.
doi: 10.1002/jmv.25932. Online ahead of print.
Diagnostic Accuracy of an Automated Chemiluminescent Immunoassay for anti-SARS-CoV-2 IgM and IgG Antibodies: An Italian Experience
M Infantino 1 , V Grossi 1 , B Lari 1 , R Bambi 1 , A Perri 1 , M Manneschi 1 , G Terenzi 1 , I Liotti 1 , G Ciotta 1 , C Taddei 1 , M Benucci 2 , P Casprini 3 , F Veneziani 4 , S Fabbri 1 4 , A Pompetti 5 , M Manfredi 1
Affiliations
- PMID: 32330291
- DOI: 10.1002/jmv.25932
Abstract
Background: A pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play.
Methods: Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab RT-PCR result.
Results: The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The ROC performance curves showed area under the curve (AUC) values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively.
Conclusions: iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics. This article is protected by copyright. All rights reserved.