Evaluation of Rapid Treponemal Test For Serodiagnosis of Syphilis
DOI:
https://doi.org/10.51253/pafmj.v76i2.12186Keywords:
Algorithm, Enzyme Linked Immunosorbent Assay, Serodiagnosis, SyphilisAbstract
Objective: To evaluate the diagnostic accuracy of a commercial treponemal immunochromatographic test (ICT) R-test Syphilis Ab Rapid test, using positivity on two treponemal tests: Treponema pallidum haemagglutination assay (TPHA) and syphilis enzyme-linked immunosorbent assay (ELISA) as reference method for serodiagnosis of syphilis, as per European Center for Disease Prevention and Control (ECDC) algorithm.
Study Design: Cross sectional validation study.
Place and Duration of Study: Department of Microbiology, Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan, from Jul to Dec 2023.
Methodology: A total of 52 samples were analyzed, where samples detected positive on both TPHA and ELISA were considered as true positives while samples testing negative by both TPHA and ELISA were considered as true negatives. Results of ICT were then compared to these. Data were incorporated in Microsoft (MS) Excel and then analyzed using Statistical Package for Social Sciences (SPSS) version 26.00.
Results: Out of 55 collected samples, 52 were analyzed of which 27(52.00%) samples were positive and 24(46.00%) were negative by both the ICT method and the ELISA/TPHA combination (ECDC algorithm) while 1(2.00%) was detected positive by ECDC approach and negative by ICT method. Therefore, ICT was found to have sensitivity, specificity, accuracy and Cohen’s kappa coefficient of 96.43%, 100.00%, 98.07% and 0.96 respectively.
Conclusion: The treponemal ICT (R-test Syphilis Ab Rapid test) was found to be highly sensitive, specific and accurate test for serodiagnosis of syphilis, making it a reliable and rapid diagnostic tool.
Downloads
References
Radolf JD, Tramont EC, Salazar JC. Syphilis (Treponema pallidum). In: Bennett JE, Dolin R, Blaser MJ, editors. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 8th ed. Elsevier; 2015. p. 2684–2709.
2. Tsuboi M, Evans J, Davies EP, Rowley J, Korenromp EL, Clayton T, et al. Prevalence of syphilis among men who have sex with men: a global systematic review and meta-analysis from 2000–2020. AIDS 2021; 29: 1110–1118.
https://doi.org/10.1097/QAD.0000000000003040
3. Maan MA, Hussain F, Iqbal J, Akhtar SJ. Sexually transmitted infections in Pakistan. Ann Saudi Med 2011; 31: 263–269. https://doi.org/10.4103/0256-4947.82343
4. Satyaputra F, Hendry S, Braddick M, Sivabalan P, Norton R. The laboratory diagnosis of syphilis. J Clin Microbiol 2021; 59: e00100-21. https://doi.org/10.1128/JCM.00100-21
5. Shah D, Marfatia YS. Serological tests for syphilis. Indian J Sex Transm Dis AIDS 2019; 40: 186–191. https://doi.org/10.4103/ijstd.IJSTD_144_18
6. Negash M, Wondmagegn T, Geremew D. Comparison of RPR and ELISA with TPHA for the diagnosis of syphilis: implication for updating syphilis point-of-care tests in Ethiopia. J Immunol Res 2018; 2018: 2978419. https://doi.org/10.1155/2018/2978419
7. Gillespie SH, Hawkey PM. Principles and practice of clinical bacteriology. 2nd ed. John Wiley & Sons Ltd; 2006.
8. Luo Y, Xie Y, Xiao Y. Laboratory diagnostic tools for syphilis: current status and future prospects. FEMS Microbiol Rev 2021; 45: fuab034. https://doi.org/10.1093/femsre/fuab034
9. Peng J, Lu Y, Yu H, Wu S, Li T, Li H, et al. Analysis of two reverse syphilis testing algorithms in diagnosis of syphilis: a large-cohort prospective study. Clin Infect Dis 2018; 67: 947–953. https://doi.org/10.1093/cid/ciy223
10. Verma A, Sachan D, Katharia R. Evaluation of various techniques for sero-diagnosis of syphilis in blood donors. Int J Innov Sci Res Technol 2019; 4(10): 930–934.
11. Randox Laboratories. IFUS archives (Internet). Available from: https://www.randox.com/tag/ifus/
12. LDS PVT. LDS PVT: Welcome. (Internet) Available from: https://ldspak.com/
13. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159–174. https://doi.org/10.2307/2529310
14. Oumar Traoré DSK, Soubeiga AP, Henry-Sangaré R, Ajayi A, Ouédraogo C, Drabo MK, et al. Evaluation of the SD Bioline Syphilis 3.0 rapid immunochromatographic test for syphilis screening in Burkina Faso. Int J Biol Chem Sci 2023; 17: 1790–1796. https://doi.org/10.17159/ijbcs.v17i5.11101
15. Nafi M, Khalid HE. Comparative evaluation of ICT and ELISA for detection of syphilis among blood donors. Eur Acad Res 2016; 3(10): 11055–11062.
16. 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: 383–386. https://doi.org/10.1002/jcla.21783
17. Diaz T, Almeida MGB, Georg I, Maia SC, Souza RV, Markowitz LE. Evaluation of the Determine Rapid Syphilis TP assay using sera. Clin Diagn Lab Immunol 2004; 11: 98–101. https://doi.org/10.1128/CDLI.11.1.98-101.2004
18. Pereira LE, McCormick J, Dorji T, Kang J, Sun Y, Shukla M, et al. Laboratory evaluation of a commercially available rapid syphilis test. J Clin Microbiol 2018; 56: e00832-18.
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Zaheer-ud-Din, Maria Mushtaq Gill, Irfan Ali Mirza, Muhammad Omair Riaz, Sakeenah Hussain Naqvi, Anam Imtiaz
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
