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Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2.
J Clin Microbiol. 2020 Jul 23; 58(8)JC

Abstract

The role of serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in both the clinical and public health settings, will continue to evolve as we gain increasing insight into our immune response to the virus. Here, we evaluated four high-throughput serologic tests for detection of anti-SARS-CoV-2 IgG antibodies, from Abbott Laboratories (Abbott Park, IL), Epitope Diagnostics, Inc. (San Diego, CA), Euroimmun (Lubeck, Germany), and Ortho-Clinical Diagnostics (Rochester, NY), using a panel of serially collected serum samples (n = 224) from 56 patients with confirmed coronavirus disease 2019 (COVID-19), healthy donor sera from 2018, and a cross-reactivity serum panel collected in early 2020. The sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays in convalescent-phase serum samples collected more than 14 days post-symptom onset or post-initial positive reverse transcriptase PCR (RT-PCR) result were 92.9% (78/84), 88.1% (74/84), 97.6% (82/84), and 98.8% (83/84), respectively. Among unique convalescent patients, sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays were 97.3% (36/37), 73% (27/37), 94.6% (35/37), and 97.3% (36/37), respectively. Overall assay specificity/positive predictive values based on a 5% prevalence rate were 99.6%/92.8%, 99.6%/90.6%, 98.0%/71.2%, and 99.6%/92.5%, respectively, for the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays. In conclusion, we show high sensitivity in convalescent-phase sera and high specificity for the Abbott, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays. With the unprecedented influx of commercially available serologic tests for detection of antibodies against SARS-CoV-2, it remains imperative that laboratories thoroughly evaluate such assays for accuracy prior to implementation.

Authors+Show Affiliations

Division of Clinical Microbiology, Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA theel.elitza@mayo.edu.Division of Clinical Microbiology, Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.Division of Clinical Microbiology, Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.Division of Clinical Microbiology, Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32513859

Citation

Theel, Elitza S., et al. "Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies Against SARS-CoV-2." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Theel ES, Harring J, Hilgart H, et al. Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2. J Clin Microbiol. 2020;58(8).
Theel, E. S., Harring, J., Hilgart, H., & Granger, D. (2020). Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.01243-20
Theel ES, et al. Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies Against SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8) PubMed PMID: 32513859.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2. AU - Theel,Elitza S, AU - Harring,Julie, AU - Hilgart,Heather, AU - Granger,Dane, Y1 - 2020/07/23/ PY - 2020/05/22/received PY - 2020/06/05/accepted PY - 2020/6/10/pubmed PY - 2020/8/5/medline PY - 2020/6/10/entrez KW - COVID-19 KW - IgG antibodies KW - SARS-CoV-2 KW - antibodies KW - serology JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - The role of serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in both the clinical and public health settings, will continue to evolve as we gain increasing insight into our immune response to the virus. Here, we evaluated four high-throughput serologic tests for detection of anti-SARS-CoV-2 IgG antibodies, from Abbott Laboratories (Abbott Park, IL), Epitope Diagnostics, Inc. (San Diego, CA), Euroimmun (Lubeck, Germany), and Ortho-Clinical Diagnostics (Rochester, NY), using a panel of serially collected serum samples (n = 224) from 56 patients with confirmed coronavirus disease 2019 (COVID-19), healthy donor sera from 2018, and a cross-reactivity serum panel collected in early 2020. The sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays in convalescent-phase serum samples collected more than 14 days post-symptom onset or post-initial positive reverse transcriptase PCR (RT-PCR) result were 92.9% (78/84), 88.1% (74/84), 97.6% (82/84), and 98.8% (83/84), respectively. Among unique convalescent patients, sensitivities of the Abbott, Epitope, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays were 97.3% (36/37), 73% (27/37), 94.6% (35/37), and 97.3% (36/37), respectively. Overall assay specificity/positive predictive values based on a 5% prevalence rate were 99.6%/92.8%, 99.6%/90.6%, 98.0%/71.2%, and 99.6%/92.5%, respectively, for the Abbott, Epitope, Euroimmun, and Ortho-Clinical IgG assays. In conclusion, we show high sensitivity in convalescent-phase sera and high specificity for the Abbott, Euroimmun, and Ortho-Clinical anti-SARS-CoV-2 IgG assays. With the unprecedented influx of commercially available serologic tests for detection of antibodies against SARS-CoV-2, it remains imperative that laboratories thoroughly evaluate such assays for accuracy prior to implementation. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32513859/Performance_Characteristics_of_Four_High_Throughput_Immunoassays_for_Detection_of_IgG_Antibodies_against_SARS_CoV_2_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32513859 DB - PRIME DP - Unbound Medicine ER -