CVI Accepts, published online ahead of print on 8 October 2008

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Clin. Vaccine Immunol. doi:10.1128/CVI.00254-08
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Performance Characteristics of Three Enzyme-linked Immunosorbent Assays for the Detection of IgG Antibodies to Tetanus Toxoid: Comparison With Reference Standards and Impact on Clinical Practice

Karen H. van Hoeven^*, Connie Dale, Phil Foster, and Barbara Body

The Binding Site, Inc., San Diego, CA; LabCorp, Burlington, NC

^* To whom correspondence should be addressed.

Accurate determination of IgG immunoglobulin concentrations to tetanus toxoid is important to evaluate the immunogenicity of tetanus toxoid vaccines, to determine immune competence in individual patients, and to measure the prevalence of immunity in populations. The performance of three commercially available enzyme-linked immunosorbent assays (ELISAs) for IgG antibodies to tetanus toxoid were evaluated. Serially diluted NIBSC 76/589 and TE-3 human tetanus IgG immunoglobulin international reference standards were analyzed in quadruplicate using ELISAs manufactured by The Binding Site, Inc (VaccZyme^TM), Scimedx, and Euroimmun. In addition, IgG antibodies to tetanus toxoid were measured in 83 deidentified serum specimens using each manufacturers' ELISAs. Each ELISA provided linear results when evaluated with the reference preparations. The Binding Site ELISA provided results that closely corresponded to the reference preparations (y = 1.09x - 0.08) whereas the Scimedx ELISA gave results that were consistently lower (y = 0.21x - 0.07), and the Euroimmun ELISA gave results that were consistently higher (y = 1.5x + 0.30) than the reference preparation concentrations. Using the recommended cut-off for each ELISA (< 0.10 IU/mL), overall agreement of all ELISA methods was 78%. Three of 83 (3.6%) human serum samples demonstrated inadequate immunity with all three assays. The Binding Site ELISA yielded nonprotective antibody concentrations in only these 3 samples, whereas 19 samples (22.9%) according to Scimedx ELISA and 6 samples (7.2%) according to Euroimmun ELISA demonstrated nonprotective concentrations. The performance characteristics of ELISAs for tetanus immunoglobulin titers were manufacturer-dependent, and the differences translated into important disparities in reported results.