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 Jul;34(7):e23275.
doi: 10.1002/jcla.23275. Epub 2020 Mar 4.

Comparison and evaluation of Abbott chemiluminescent microparticle immunoassay and ChIVD light-initiated chemiluminescent assay in the detection of Treponema pallidum antibody

Xiaohui Chen  1 , Ruifeng Yang  2 , Yongming Liang  1 , Teng Yuan  1 , Jiansuo Zhou  1 , Tiancheng Wang  1 , Liyan Cui  1
Affiliations
Comparative Study

Comparison and evaluation of Abbott chemiluminescent microparticle immunoassay and ChIVD light-initiated chemiluminescent assay in the detection of Treponema pallidum antibody

Xiaohui Chen et al. J Clin Lab Anal. 2020 Jul.

Abstract

Background: Laboratory tests play an important role in the diagnosis of syphilis. This study aimed to compare and assess the performance of the Abbott chemiluminescent microparticle immunoassay (CMIA) and the ChIVD light-initiated chemiluminescent assay (LICA) in the detection of Treponema pallidum (TP) antibody.

Methods: A total of 10 498 serum samples were detected with two assays, and the Treponema pallidum particle agglutination assay (TPPA) and recombinant immunoblot assay (RIBA) methods were used for confirmation. The sensitivity, specificity, positive predictive value, and negative predictive value of the Abbott CMIA and ChIVD LICA were calculated. The coincidence rate between two assays was also evaluated. The causes of false positive and false negative of two assays were studied.

Results: For the Abbott CMIA and ChIVD LICA, the sensitivity was 94.44% and 98.15%, the specificity was 99.89% and 99.81%, the positive predictive value was 93.29% and 88.83%, and the negative predictive value was 99.91% and 99.97%, respectively. The coincidence rate between Abbott CMIA and ChIVD LICA was 99.26%, and κ value was .790. The disease of infertility, hypertensive disease, liver disease, and cancer were the common causes of false positive in both assays, while infertility was also the main reason lead to false negative.

Conclusion: Our results demonstrated that the Abbott CMIA and ChIVD LICA generally had high sensitivity and specificity and therefore may be suitable for the detection of TP antibody and screening for syphilis.

Keywords: Treponema pallidum; Abbott chemiluminescent microparticle immunoassay; ChIVD light-initiated chemiluminescent assay; Treponema pallidum particle agglutination; recombinant immunoblot assay; syphilis.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Testing algorithms of Treponema pallidum antibody detection. Abbreviations: CMIA, chemiluminescent microparticle immunoassay; LICA, light‐initiated chemiluminescent assay; RIBA, recombinant immunoblot assay; TPPA, treponema pallidum particle agglutination
See this image and copyright information in PMC

References

    1. Zhang X, Hou F, Li X, Zhou L, Liu Y, Zhang T. Study of surveillance data for class B notifiable disease in China from 2005 to 2014. Int J Infect Dis. 2016;48:7‐13. - PMC - PubMed
    1. Stamm LV. Syphilis: Re‐emergence of an old foe. Microb Cell. 2016;3(9):363‐370. - PMC - PubMed
    1. Janier M, Hegyi V, Dupin N, et al. 2014 European guideline on the management of syphilis. J Eur Acad Dermatol Venereol. 2014;28(12):1581‐1593. - PubMed
    1. Naidu NK, Bharucha ZS, Sonawane V, Ahmed I. Comparative study of Treponemal and non‐Treponemal test for screening of blood donated at a blood center. Asian J Transfus Sci. 2012;6(1):32‐35. - PMC - PubMed
    1. Liu F, Liu LL, Guo XJ, et al. Characterization of the classical biological false‐positive reaction in the serological test for syphilis in the modern era. Int Immunopharmacol. 2014;20(2):331‐336. - PubMed

Substances