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Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays.
J Immunol Methods. 2020 11; 486:112837.JI

Abstract

Coronavirus Disease 2019 (COVID-19) convalescent plasma (CCP) was approved by the FDA for use in severe cases of COVID-19 under an emergency Investigational New Drug (IND) protocol. Eligibility criteria for CCP donors includes documentation of evidence of COVID-19 either by viral RNA detection at the time of illness or positive SARS-CoV-2 IgG after recovery if diagnostic testing for COVID-19 was not performed at the time of illness. In addition to analysis of CCP, analysis of SARS-CoV-2 IgG provides information for possible past exposure and may support diagnosis when SARS-CoV-2 PCR is negative and clinical suspicion for COVID-19 is high. Furthermore, assays with high sensitivity and specificity for SARS-CoV-2 IgG are critical for understanding community exposure rates to SARS-CoV-2. Currently, there are several assays that test for antibodies to SARS-CoV-2 using a variety of methods, including point-of-care lateral flow-based devices, high throughput immunoassay analyzers, and manual methods such as ELISA. These assays target a number of SARS-CoV-2 antigens, including the nucleocapsid protein (N), full length spike protein (S), S1 subunit, or receptor binding domain (RBD) of the S protein. Given the heterogeneity among methods for, and antigenic targets used in SARS-CoV-2 antibody assays, it is necessary for careful evaluation of these assays prior to implementation for clinical use. We compared two assays that had received the CE mark of regulatory approval and that used either the N antigen or S1-RBD antigen as the target for analysis of a large set of CCP samples. Our data indicates that sensitivity and specificity vary between these assays and that more than one antigenic target may be required to improve the sensitivity and specificity of IgG detection to SARS-CoV-2.

Authors+Show Affiliations

Department of Pathology, University of Colorado School of Medicine, 12631 East 17th Avenue, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America. Electronic address: melkon.dombourian@childrenscolorado.org.Department of Pathology, University of Colorado School of Medicine, 12631 East 17th Avenue, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States of America; Children's Hospital Colorado, 13123 East 16(th) Avenue, Aurora, CO 80045, United States of America.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32828791

Citation

DomBourian, Melkon G., et al. "Analysis of COVID-19 Convalescent Plasma for SARS-CoV-2 IgG Using Two Commercial Immunoassays." Journal of Immunological Methods, vol. 486, 2020, p. 112837.
DomBourian MG, Annen K, Huey L, et al. Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays. J Immunol Methods. 2020;486:112837.
DomBourian, M. G., Annen, K., Huey, L., Andersen, G., Merkel, P. A., Jung, S., Dominguez, S. R., & Knight, V. (2020). Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays. Journal of Immunological Methods, 486, 112837. https://doi.org/10.1016/j.jim.2020.112837
DomBourian MG, et al. Analysis of COVID-19 Convalescent Plasma for SARS-CoV-2 IgG Using Two Commercial Immunoassays. J Immunol Methods. 2020;486:112837. PubMed PMID: 32828791.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays. AU - DomBourian,Melkon G, AU - Annen,Kyle, AU - Huey,Leah, AU - Andersen,Gillian, AU - Merkel,Patricia A, AU - Jung,Sarah, AU - Dominguez,Samuel R, AU - Knight,Vijaya, Y1 - 2020/08/20/ PY - 2020/06/26/received PY - 2020/08/05/revised PY - 2020/08/12/accepted PY - 2020/8/24/pubmed PY - 2020/8/24/medline PY - 2020/8/24/entrez SP - 112837 EP - 112837 JF - Journal of immunological methods JO - J Immunol Methods VL - 486 N2 - Coronavirus Disease 2019 (COVID-19) convalescent plasma (CCP) was approved by the FDA for use in severe cases of COVID-19 under an emergency Investigational New Drug (IND) protocol. Eligibility criteria for CCP donors includes documentation of evidence of COVID-19 either by viral RNA detection at the time of illness or positive SARS-CoV-2 IgG after recovery if diagnostic testing for COVID-19 was not performed at the time of illness. In addition to analysis of CCP, analysis of SARS-CoV-2 IgG provides information for possible past exposure and may support diagnosis when SARS-CoV-2 PCR is negative and clinical suspicion for COVID-19 is high. Furthermore, assays with high sensitivity and specificity for SARS-CoV-2 IgG are critical for understanding community exposure rates to SARS-CoV-2. Currently, there are several assays that test for antibodies to SARS-CoV-2 using a variety of methods, including point-of-care lateral flow-based devices, high throughput immunoassay analyzers, and manual methods such as ELISA. These assays target a number of SARS-CoV-2 antigens, including the nucleocapsid protein (N), full length spike protein (S), S1 subunit, or receptor binding domain (RBD) of the S protein. Given the heterogeneity among methods for, and antigenic targets used in SARS-CoV-2 antibody assays, it is necessary for careful evaluation of these assays prior to implementation for clinical use. We compared two assays that had received the CE mark of regulatory approval and that used either the N antigen or S1-RBD antigen as the target for analysis of a large set of CCP samples. Our data indicates that sensitivity and specificity vary between these assays and that more than one antigenic target may be required to improve the sensitivity and specificity of IgG detection to SARS-CoV-2. SN - 1872-7905 UR - https://www.unboundmedicine.com/medline/citation/32828791/Analysis_of_COVID_19_convalescent_plasma_for_SARS_CoV_2_IgG_using_two_commercial_immunoassays_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-1759(20)30121-6 DB - PRIME DP - Unbound Medicine ER -