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Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies.
J Clin Virol. 2020 08; 129:104468.JC

Abstract

As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. Of 86 samples from SARS-CoV-2 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 76 tested negative and 10 tested positive for IgA (88.4% agreement, 95% CI: 79.9-93.6) while 84 tested negative and 2 tested positive for IgG (97.7% agreement, 95% CI: 91.9-99.6). Of 82 samples from SARS-CoV-2 PCR-positive patients, 14 tested negative and 68 tested positive for IgA (82.9% agreement, 95% CI: 73.4-89.5) while 27 tested negative and 55 tested positive for IgG (67.1% agreement, 95% CI: 56.3-76.3). Of samples collected ≥4 days after positive PCR, 38 of 42 (90.5% agreement, 95% CI: 77.9-96.2) were positive for IgA, and 42 of 42 (100% agreement, 95% CI: 91.6-100) were positive for IgG, respectively. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrated good sensitivity for detection of IgA and excellent sensitivity for detection of IgG antibodies from samples collected ≥4 days, after COVID-19 diagnosis by PCR. This assay demonstrated good specificity for IgA and excellent specificity for IgG and demonstrated only borderline cross reaction in 2 of the 28 samples from patients with common human coronaviruses infection, types NL63 and OC43.

Authors+Show Affiliations

Department of Pathology, University of Chicago, Chicago, IL 60637-1470, USA.Clinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, IL, USA.Clinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, IL, USA.Clinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, IL, USA.Clinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, IL, USA.Clinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, IL, USA.Department of Pathology, University of Chicago, Chicago, IL 60637-1470, USA.Department of Pathology, University of Chicago, Chicago, IL 60637-1470, USA. Electronic address: vtesic@bsd.uchicago.edu.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32485620

Citation

Beavis, Kathleen G., et al. "Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for Detection of IgA and IgG Antibodies." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104468.
Beavis KG, Matushek SM, Abeleda APF, et al. Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies. J Clin Virol. 2020;129:104468.
Beavis, K. G., Matushek, S. M., Abeleda, A. P. F., Bethel, C., Hunt, C., Gillen, S., Moran, A., & Tesic, V. (2020). Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104468. https://doi.org/10.1016/j.jcv.2020.104468
Beavis KG, et al. Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for Detection of IgA and IgG Antibodies. J Clin Virol. 2020;129:104468. PubMed PMID: 32485620.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies. AU - Beavis,Kathleen G, AU - Matushek,Scott M, AU - Abeleda,Ana Precy F, AU - Bethel,Cindy, AU - Hunt,Carlissa, AU - Gillen,Stephanie, AU - Moran,Angelica, AU - Tesic,Vera, Y1 - 2020/05/23/ PY - 2020/05/16/received PY - 2020/05/20/accepted PY - 2020/6/3/pubmed PY - 2020/8/12/medline PY - 2020/6/3/entrez KW - COVID-19 KW - SARS-CoV-2 KW - Serology SP - 104468 EP - 104468 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. Of 86 samples from SARS-CoV-2 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 76 tested negative and 10 tested positive for IgA (88.4% agreement, 95% CI: 79.9-93.6) while 84 tested negative and 2 tested positive for IgG (97.7% agreement, 95% CI: 91.9-99.6). Of 82 samples from SARS-CoV-2 PCR-positive patients, 14 tested negative and 68 tested positive for IgA (82.9% agreement, 95% CI: 73.4-89.5) while 27 tested negative and 55 tested positive for IgG (67.1% agreement, 95% CI: 56.3-76.3). Of samples collected ≥4 days after positive PCR, 38 of 42 (90.5% agreement, 95% CI: 77.9-96.2) were positive for IgA, and 42 of 42 (100% agreement, 95% CI: 91.6-100) were positive for IgG, respectively. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrated good sensitivity for detection of IgA and excellent sensitivity for detection of IgG antibodies from samples collected ≥4 days, after COVID-19 diagnosis by PCR. This assay demonstrated good specificity for IgA and excellent specificity for IgG and demonstrated only borderline cross reaction in 2 of the 28 samples from patients with common human coronaviruses infection, types NL63 and OC43. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32485620/Evaluation_of_the_EUROIMMUN_Anti_SARS_CoV_2_ELISA_Assay_for_detection_of_IgA_and_IgG_antibodies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30210-9 DB - PRIME DP - Unbound Medicine ER -