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. 2015 Nov;29(6):493-7.
doi: 10.1002/jcla.21799. Epub 2014 Oct 2.

Establishment and Evaluation of a One-Step Microplate Chemiluminescence Immunoassay to Detect IgG Antibody Against Treponema Pallidum

Lijuan Liu  1 , Yuling Xie  2 , Zhenxian Dai  2 , Chuanshang Zhuo  1 , Yushui Wu  2
Affiliations

Establishment and Evaluation of a One-Step Microplate Chemiluminescence Immunoassay to Detect IgG Antibody Against Treponema Pallidum

Lijuan Liu et al. J Clin Lab Anal. 2015 Nov.

Abstract

Background: The serological detection of specific antibodies against Treponema pallidum is of particular importance in the diagnosis of syphilis. The chemiluminescence immunoassay (CLIA) has been widely used for clinical diagnosis because they remit no radical waste products, cause no enzyme precipitation, and exhibit an excellent sensitivity.

Methods: A one-step CLIA was established to detect T. pallidum IgG antibody based on microplate coated with a mixture of recombinant T. pallidum antigens TpN15, TpN17, and TpN47. The Chinese national reference substances standard panel for T. pallidum diagnosis was applied to test the accuracy, stability, interference, and cross-reactivity of the established CLIA. The validation of efficacy for clinical application was performed by comparing the established method with the marketed T. pallidum particle agglutination (TPPA) kit and the Abbott ARCHITEC Auto System.

Results: The established method met the requirement of the Chinese national reference substances standard for T. pallidum diagnosis. When compared with TPPA (n = 1,052), the specificity, sensitivity, and overall concordance were 99.7%, 99.0%, and 98.8% respectively, showing a great agreement with a kappa value of 0.81. When compared with the Abbott ARCHITEC Auto System (n = 352), the results showed that the specificity, sensitivity, and overall concordance were 98.6.0%, 96.6% and 98.6% respectively, and a high-degree agreement was observed (kappa value = 0.95).

Conclusion: The established rapid, specific, sensitive, and stable microplate CLIA method to detect IgG antibody against T pallidum will provide an efficient alternative to the treponemal tests and wide application in clinical laboratory.

Keywords: IgG; Treponema pallidum; antibody; chemiluminescence; diagnosis.

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References

    1. Müller I, Brade V, Hagedorn HJ, et al. Is serological testing a reliable tool in laboratory diagnosis of syphilis? Meta‐analysis of eight external quality control surveys performed by the German infection serology proficiency testing program. J Clin Microbiol 2006;44:1335–1341. - PMC - PubMed
    1. Larsen SA, Steiner BM, Rudolp AH. Laboratory diagnosis and interpretation of tests for syphilis. Clin Microbiol Rev 1995;8:1–21. - PMC - PubMed
    1. Jurado RL, Campbell J, Martin PD. Prozone phenomenon in secondary syphilis. Has its time arrived? Arch Intern Med 1993;153:2496–2498. - PubMed
    1. Larsen SA, Hambie EA, Pettit DE, Perryman MW, Kraus SJ. Specificity, sensitivity, and reproducibility among the fluorescent treponemal antibody‐absorption test, the microhemagglutination assay for Treponema pallidum antibodies, and the hemagglutination treponemal test for syphilis. J Clin Microbiol 1981;14:441–445. - PMC - PubMed
    1. Sambri V, Marangoni A, Simone MA, D'Antuono A, Negosanti M, Cevenini R. Evaluation of recomWell Treponema, a novel recombinant antigen‐based enzyme‐linked immunosorbent assay for the diagnosis of syphilis. Clin Microbiol Infect 2001;7:200–205. - PubMed

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