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Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays.
J Clin Virol. 2020 08; 129:104480.JC

Abstract

Serological SARS-CoV-2 assays are urgently needed for diagnosis, contact tracing and for epidemiological studies. So far, there is limited data on how recently commercially available, high-throughput immunoassays, using different recombinant SARS-CoV-2 antigens, perform with clinical samples. Focusing on IgG and total antibodies, we demonstrate the performance of four automated immunoassays (Abbott Architect™ i2000 (N protein-based)), Roche cobas™ e 411 analyzer (N protein-based, not differentiating between IgA, IgM or IgG antibodies), LIAISON®XL platform (S1 and S2 protein-based), VIRCLIA® automation system (S1 and N protein-based) in comparison to two ELISA assays (Euroimmun SARS-CoV-2 IgG (S1 protein-based) and Virotech SARS-CoV-2 IgG ELISA (N protein-based)) and an in-house developed plaque reduction neutralization test (PRNT). We tested follow up serum/plasma samples of individuals PCR-diagnosed with COVID-19. When calculating the overall sensitivity, in a time frame of 49 days after first PCR-positivity, the PRNT as gold standard, showed the highest sensitivity with 93.3% followed by the dual-target assay for the VIRCLIA® automation system with 89%. The overall sensitivity in the group of N protein-based assays ranged from 66.7 to 77.8% and in the S protein-based-assays from 71.1 to 75.6%. Five follow-up samples of three individuals were only detected in either an S and/or N protein-based assay, indicating an individual different immune response to SARS-CoV-2 and the influence of the used assay in the detection of IgG antibodies. This should be further analysed. The specificity of the examined assays was ≥ 97%. However, because of the low or unknown prevalence of SARS-CoV-2, the examined assays in this study are currently primarily eligible for epidemiological investigations, as they have limited information in individual testing.

Authors+Show Affiliations

Institute for Medical Virology, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.Institute for Medical Virology, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.Institute for Medical Virology, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.Institute for Medical Virology, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany; German Centre for Infection Research, External Partner Site, Frankfurt, Germany; Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Branch Translational Medicine and Pharmacology, Frankfurt, Germany.Institute for Medical Virology, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany. Electronic address: rabenau@em.uni-frankfurt.de.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32505777

Citation

Kohmer, Niko, et al. "Brief Clinical Evaluation of Six High-throughput SARS-CoV-2 IgG Antibody Assays." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104480.
Kohmer N, Westhaus S, Rühl C, et al. Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays. J Clin Virol. 2020;129:104480.
Kohmer, N., Westhaus, S., Rühl, C., Ciesek, S., & Rabenau, H. F. (2020). Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104480. https://doi.org/10.1016/j.jcv.2020.104480
Kohmer N, et al. Brief Clinical Evaluation of Six High-throughput SARS-CoV-2 IgG Antibody Assays. J Clin Virol. 2020;129:104480. PubMed PMID: 32505777.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays. AU - Kohmer,Niko, AU - Westhaus,Sandra, AU - Rühl,Cornelia, AU - Ciesek,Sandra, AU - Rabenau,Holger F, Y1 - 2020/06/01/ PY - 2020/05/24/received PY - 2020/05/28/revised PY - 2020/05/31/accepted PY - 2020/6/9/pubmed PY - 2020/8/12/medline PY - 2020/6/8/entrez KW - Antibody KW - Assay KW - Evaluation KW - IgG KW - PRNT KW - SARS-CoV-2 SP - 104480 EP - 104480 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - Serological SARS-CoV-2 assays are urgently needed for diagnosis, contact tracing and for epidemiological studies. So far, there is limited data on how recently commercially available, high-throughput immunoassays, using different recombinant SARS-CoV-2 antigens, perform with clinical samples. Focusing on IgG and total antibodies, we demonstrate the performance of four automated immunoassays (Abbott Architect™ i2000 (N protein-based)), Roche cobas™ e 411 analyzer (N protein-based, not differentiating between IgA, IgM or IgG antibodies), LIAISON®XL platform (S1 and S2 protein-based), VIRCLIA® automation system (S1 and N protein-based) in comparison to two ELISA assays (Euroimmun SARS-CoV-2 IgG (S1 protein-based) and Virotech SARS-CoV-2 IgG ELISA (N protein-based)) and an in-house developed plaque reduction neutralization test (PRNT). We tested follow up serum/plasma samples of individuals PCR-diagnosed with COVID-19. When calculating the overall sensitivity, in a time frame of 49 days after first PCR-positivity, the PRNT as gold standard, showed the highest sensitivity with 93.3% followed by the dual-target assay for the VIRCLIA® automation system with 89%. The overall sensitivity in the group of N protein-based assays ranged from 66.7 to 77.8% and in the S protein-based-assays from 71.1 to 75.6%. Five follow-up samples of three individuals were only detected in either an S and/or N protein-based assay, indicating an individual different immune response to SARS-CoV-2 and the influence of the used assay in the detection of IgG antibodies. This should be further analysed. The specificity of the examined assays was ≥ 97%. However, because of the low or unknown prevalence of SARS-CoV-2, the examined assays in this study are currently primarily eligible for epidemiological investigations, as they have limited information in individual testing. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32505777/Brief_clinical_evaluation_of_six_high_throughput_SARS_CoV_2_IgG_antibody_assays_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30222-5 DB - PRIME DP - Unbound Medicine ER -