Comparison of agreement among treponemal testing methods
DOI:
https://doi.org/10.14456/taj.2026.13Keywords:
syphilis, treponemal test, electrochemiluminescence immunoassay, immunochromatographic testAbstract
This study aimed to compare the agreement of Treponema pallidum antibody detection between electrochemiluminescence immunoassay (ECLIA) and immunochromatographic test (ICT), using TPHA as the reference treponemal test. A total of 204 serum samples were re-evaluated using a treponemal testing algorithm, beginning with TPHA followed by RPR. The positive percentage agreement (PPA) values were 97.78% and 78.13%, respectively. The negative percentage agreement (NPA) was 100% for both methods, and the overall percentage agreement (OPA) values were 99.41% and 95.60%, respectively. The kappa coefficients indicated almost perfect agreement (kappa = 0.99, 0.86, respectively. From a clinical significance perspective, the results demonstrated that ECLIA showed a higher degree of agreement with TPHA than ICT among the pre-selected samples. Furthermore, treponemal tests demonstrated high diagnostic performance, with high sensitivity and specificity. They can detect latent infection and cases with a history of prior treatment. ECLIA provides high sensitivity and specificity and yields quantitative results, making it appropriate for laboratories requiring high analytical accuracy, despite its higher cost and instrument requirements. In contrast, ICT as a rapid test provides rapid results, ease of use, and lower cost, making it suitable for initial screening in resource-limited settings. However, ICT has lower sensitivity and specificity and cannot be used to monitor antibody levels. Therefore, using ICT for preliminary screening in combination with ECLIA for confirmation may enhance overall diagnostic effectiveness and suit the context of healthcare services at different levels.
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References
Bureau of Risk Communication and Health Literacy, Department of Disease Control. Syphilis [Internet]. 2024 [cited 2025 Jun 11]. Available from: https://ddc.moph.go.th/brc/news.php?deptcode=brc&news=44807 (in Thai)
PPTV Online. Syphilis statistics in 2025: 12,485 cases reported; free resting available twice a year [Internet]. 2025 [cited 2025 Jun 24]. Available from: https://www.pptvhd36.com/health/news/7021 (in Thai)
Department of Disease Control. Situation of sexually transmitted infections in Thailand, fiscal year 2025, quarter 4: Division of AIDS and STIs [Internet]. 2025 [cited 2025 Nov 19]. Available from: https://hivhub.ddc.moph.go.th
Chaiyamahapurk S, Kittiyaowaman R. Syphilis: resurgence. Disease Control Journal. 2021;47(2):199-208. (in Thai)
World Health Organization. WHO guideline on syphilis screening and treatment for pregnant women [Internet]. 2017 [cited 2025 Jun 11]. Available from: https://www.who.int/publications/i/item/9789241550093
Chaisongkram N. Epidemiological characteristics among patients with syphilis in Thailand. Disease Control Journal. 2023;49(1):51-61. (in Thai)
Yongpradit J. The treatment outcome of infant born from syphilis-infected pregnant women at Sampran Hospital, Nakhon Pathom Province. Thai Journal of Pediatrics. 2021;60(2):118-31. (in Thai)
World Health Organization. WHO guidelines for the treatment of Treponema pallidum (syphilis) [Internet]. 2016 [cited 2025 Jun 11]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK384906/
Department of Disease Control. National guideline for syphilis testing: laboratory manual for diagnosis and monitoring [Internet]. 2021 [cited 2025 Jun 11]. Available from: https://ddc.moph.go.th/uploads/publish/1126820210330151117.pdf (in Thai)
Homsukon N. Comparison of the efficacy of syphilis screening using traditional and reverse algorithms in pregnant women and their sexual partners at Wichanburi Hospital, Phetchabun Province, Thailand. Phetchabun Medical Journal. 2024;4(3):1-12. (in Thai)
Department of Disease Control. Diagnostic and monitoring guidelines for treatment: Department of Disease Control, Ministry of Public Health [Internet]. 2025 [cited 2025 Nov 19]. Available from: https://www.ddc.moph.go.th/uploads/publish/1731520251021162402.pdf. (in Thai)
Chomean S, Puttaruk P, Khamsophar P, Fukpo W, Kaset C. Evaluation of rapid diagnostic test kits for detection of Treponema pallidum antibody. PLoS One. 2024;19(5):e0303477.
Lee JH, Lim CS, Lee MG, Kim HS. Evaluation of a rapid immunochromatographic treponemal antibody test comparing the Treponema pallidum particle agglutination assay. J Clin Lab Anal. 2015;29(5):383-6.
Naing L, Nordin RB, Rahman HA, Naing YT. Sample size calculation for prevalence studies using Scalex. BMC Med Res Methodol [Internet]. 2022 [cited 2025 Nov 18];22(1):209. Available from: https://doi.org/10.1186/s12874-022-01694-7
Rapid Labs Ltd. TPHA test kit (Treponema pallidum hemagglutination test) [Internet]. 2016 [cited 2025 Jun 12]. Available from: https://www.rapidlabs.co.uk/wp-content/uploads/TPHA-100T-200T-500T-IFU-CE-rev6-multiple.pdf.
Rapid Labs Ltd. RPR test kit (rapid plasma reagin test) [Internet]. 2016 [updated 2023 Aug 15; cited 2025 Jun 12]. Available from: https://www.rapidlabs.co.uk/wp-content/uploads/RPR-100-250-500T-IFU-CE-rev6.pdf
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159-74.
Chaiwong K, Intharasongkroh D, Kimila R, Songubol U, Wattanakul V, Khumnan N, et al. Evaluation of test kit for detecting Treponema pallidum antibodies in donated blood with immunochromatographic strip. Journal of Hematology and Transfusion Medicine. 2014;24(3):261-67. (in Thai)
Masenga SK, Mweemba M, Kachele A, Chalubemba Y, Toloka P, Hamooya MB. Lessons from a comparison of immunochromatographic and chemiluminescent microparticle immunoassay in the diagnosis of syphilis. BMC Res Notes. 2018;11(1):701.
Terzi HA, Aydemir O, Karakece E, Hatipoglu H, Olmez M, Koroglu M, et al. Investigation of the rapid immunochromatographic test performance in the diagnosis of syphilis: comparison of four serological methods. J Lab Med [Internet]. 2020 [cited 2025 Jun 13];44(4):221-5. Available from: https://doi.org/10.1515/labmed-2019-0012
Li L, Cai B, Tao C, Wang L. Performance evaluation of CLIA for Treponema pallidum-specific antibodies detection in comparison with ELISA. J Clin Lab Anal. 2016;30:216-22.
Zhou J, Liang Y, Zhang J, Cui L. The analyzation and clinical evaluation of ECLIA and CMIA in the detection of Treponema pallidum. Medicine (Baltimore). 2017;96(24):e7139.
Ismail A, Younes N, Ayoub H, Nasrallah DF, Al-Emadi JA, Khalid HM, et al. Evaluating chemiluminescent immunoassays for syphilis detection: a comparative analysis. J Infect Public Health. 2025;18(6):102731.
Kakkar B, Philip J, Mallhi SR. Comparative evaluation of rapid plasma reagin and ELISA with Treponema pallidum hemagglutination assay for the detection of syphilis in blood donors: a single center experience. Hematol Transfus Cell Ther. 2024;46(Suppl 5):S43-7.
Bouchehboun A, Farhat J, Mhirig I, Benhoumich T, Lamrani A, Sora N. Syphilis serology in focus: TPHA or CMIA? A comparative study in a Moroccan tertiary care center. SAS J Med. 2025;11(5):542-5.
Pham DM, Wise A, Garcia LM, Van H, Zheng S, Mohamed Y, et al. Improving the coverage and accuracy of syphilis testing: the development of a novel rapid, point-of-care test for confirmatory testing of active syphilis infection and its early evaluation in China and South Africa. EClinicalMedicine. 2020;24:100440
Caya C, Singh AE, Serhir B, Morin V, Libman DM, Corsini R, et al. Rapid diagnostic testing for syphilis in Arctic communities (the STAR study): a multisite prospective field diagnostic accuracy study in an intended-use setting. Clin Microbiol Infect. 2023;29(10):1335.e1-1335.e7.
Division of AIDS and STIs, Department of Disease Control. Prevention and management of mother-to-child transmission of syphilis guideline [Internet]. 2021 [cited 2025 Nov 18]. Available from: https://stisqsa.ddc.moph.go.th/app-assets/manual/แนวทางการกำจัดโรคซิฟิลิสแต่กำเนิด%20พ.ศ.%202563.pdf? (in Thai)