Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2020 Nov:486:112837.
doi: 10.1016/j.jim.2020.112837. Epub 2020 Aug 20.

Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays

Melkon G DomBourian  1 , Kyle Annen  2 , Leah Huey  3 , Gillian Andersen  4 , Patricia A Merkel  3 , Sarah Jung  4 , Samuel R Dominguez  3 , Vijaya Knight  3
Affiliations
Comparative Study

Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays

Melkon G DomBourian et al. J Immunol Methods. 2020 Nov.

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.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest All authors declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Comparison of SARS-CoV-2 IgG in SARS-CoV-2 PCR-positive samples analyzed by the Epitope and Euroimmun ELISA. Red symbols: negative by Epitope and positive by Euroimmun; Green symbols: positive by Epitope and negative by Euroimmun; Orange symbols: borderline by Epitope and positive by Euroimmun; Black symbols: borderline by Euroimmun and positive by Epitope; Blue symbols: borderline by Euroimmun and negative by Epitope. Open circles indicate correlative results between the two assays. (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.)
Fig. 2
Fig. 2
Analysis of SARS-CoV-2 PCR-positive samples, pre-pandemic samples and SARS-CoV-2 PCR-negative/respiratory viral panel-positive samples (RPP) by the Epitope and Euroimmun ELISA.
Fig. 3
Fig. 3
Receiver Operating Characteristics curves for the Epitope (OD) and Euroimmun (Ratio) ELISA based on the manufacturer's recommended calculations for positive and negative cut-off values.
See this image and copyright information in PMC

References

    1. Ahmed S.F., Quadeer A.A., Mckay M.R. Preliminary identification of potential vaccine targets for the COVID-19 coronavirus (SARS-CoV-2) based on SARS-CoV immunological studies. Viruses. 2020 doi: 10.3390/v12030254. - DOI - PMC - PubMed
    1. Cheng Y., Wong R., Soo Y.O.Y., Wong W.S., Lee C.K., Ng M.H.L., Chan P., Wong K.C., Leung C.B., Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur. J. Clin. Microbiol. Infect. Dis. 2005 doi: 10.1007/s10096-004-1271-9. - DOI - PMC - PubMed
    1. Duan K., Liu B., Li C., Zhang H., Yu T., Qu J., Zhou M., Chen L., Meng S., Hu Y., Peng C., Yuan M., Huang J., Wang Z., Yu J., Gao X., Wang D., Yu X., Li L., Zhang J., Wu X., Li B., Xu Y., Chen W., Peng Y., Hu Y., Lin L., Liu X., Huang S., Zhou Z., Zhang L., Wang Y., Zhang Z., Deng K., Xia Z., Gong Q., Zhang W., Zheng X., Liu Y., Yang H., Zhou D., Yu D., Hou J., Shi Z., Chen S., Chen Z., Zhang X., Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc. Natl. Acad. Sci. 2020 doi: 10.1073/pnas.2004168117. - DOI - PMC - PubMed
    1. Hung I.F., To, K.K, Lee C.-K., Lee K.-L., Chan K., Yan W.-W., Liu R., Watt C.-L., Chan W.-M., Lai K.-Y., Koo C.-K., Buckley T., Chow F.-L., Wong K.-K., Chan H.-S., Ching C.-K., Tang B.S., Lau C.C., Li I.W., Liu S.-H., Chan K.-H., Lin C.-K., Yuen K.-Y. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin. Infect. Dis. 2011 doi: 10.1093/cid/ciq106. - DOI - PMC - PubMed
    1. Infectious Disease Society of America IDSA COVID-19 Antibody Testing Primer. 2020. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-... (accessed 05 June 2020)

MeSH terms