Diagnostic accuracy of an automated chemiluminescent immunoassay for anti-SARS-CoV-2 IgM and IgG antibodies: an Italian experience

Maria Infantino, Valentina Grossi, Barbara Lari, Riccardo Bambi, Alessandro Perri, Matteo Manneschi, Giovanni Terenzi, Irene Liotti, Giovanni Ciotta, Cristina Taddei, Maurizio Benucci, Patrizia Casprini, Francesca Veneziani, Sergio Fabbri, Adolfo Pompetti, Mariangela Manfredi, Maria Infantino, Valentina Grossi, Barbara Lari, Riccardo Bambi, Alessandro Perri, Matteo Manneschi, Giovanni Terenzi, Irene Liotti, Giovanni Ciotta, Cristina Taddei, Maurizio Benucci, Patrizia Casprini, Francesca Veneziani, Sergio Fabbri, Adolfo Pompetti, Mariangela Manfredi

Abstract

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. 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 reverse-transcription polymerase chain reaction result. 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 receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. 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.

Keywords: SARS coronavirus; coronavirus; humoral immunity; immune responses; virus classification.

© 2020 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Reciever operating characterstic analysis for anti‐SARS‐CoV‐2 antibodies detection
Figure 2
Figure 2
Distribution of anti‐SARS‐CoV‐2 IgM and IgG antibodies levels in COVID‐19 patients and in the control group at the manufacturer's cutoff

References

    1. Lu R, Zhao X, Li J, et al. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020;395:565‐574.
    1. Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus‐infected pneumonia. N Engl J Med. 2020;382:1199‐1207.
    1. World Health Organization. (‎2020)‎ . Laboratory testing for coronavirus disease 2019 (‎COVID‐19)‎ in suspected human cases: interim guidance, 2 March 2020. World Health Organization.
    1. Infantino M, Damiani A, Gobbi FL, et al. Serological assays for SARS‐CoV‐2 infectious disease: benefits, limitations and perspectives. Isr Med Assoc J. 2020;22:203‐210.
    1. Okba NMA, Müller MA, Li W. SARS‐CoV‐2 specific antibody responses in COVID‐19 patients. medRxiv. 2020.
    1. Centers for Disease Control and Prevention . Coronavirus disease 2019 (COVID‐19)–Information for Laboratories. . Accessed on April 11, 2020.
    1. Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID‐19 and potential vaccines: Lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol. 2020;38:1‐9.
    1. Cassaniti I, Novazzi F, Giardina F, et al. Performance of VivaDiag COVID‐19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID‐19 in acute patients referring to emergency room department. J Med Virol. 2020.
    1. U.S. Food & Drug Administration , Policy for Diagnostic Tests for Coronavirus Disease‐2019 during the Public Health Emergency. . Accessed on March 16, 2020.
    1. Li Z, Yi Y, Luo X, et al. Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis. J Med Virol. 2020.
    1. Tan W, Lu Y, Zhang J, et al. Viral kinetics and antibody responses in patients with COVID‐19. medRxiv. 2020.
    1. Zeng F, Dai C, Cai P, et al. A comparison study of SARS‐CoV‐2 IgG antibody between male and female COVID‐19 patients: a possible reason underlying different outcome between gender. medRxiv 2020.
    1. Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for 2019‐nCov IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020.
    1. Jin Y, Wang M, Zuo Z, et al. Diagnostic value and dynamic variance of serum antibody in coronavirus disease 2019. Int J Infect Dis. 2020;94:49‐52.
    1. Lippi G, Salvagno GL, Pegoraro M, et al. Assessment of immune response to SARS‐CoV‐2 with fully‐automated MAGLUMI 2019‐nCoV IgG and IgM chemiluminescence immunoassays. Clin Chem Lab Med. 2020.
    1. Binnicker MJ. Emergence of a novel coronavirus disease (COVID‐19) and the importance of diagnostic testing: why partnership between clinical laboratories, public health agencies, and industry is essential to control the outbreak. Clin Chem. 2020.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren