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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.JI

Abstract

BACKGROUND

Syphilis is a sexually transmitted disease (STD) caused by the spirochete Treponema pallidum, and it persists to be a major public health problem in Africa, including Ethiopia. Syphilis diagnosis is made by either nontreponemal or treponemal approaches, though in developing countries the diagnosis relies mostly on nonspecific tests due to several reasons. Thus, the objective of this study was to assess the sensitivity, specificity, predictive values, and agreement of rapid plasma reagin (RPR) and enzyme-linked immunosorbent assay (ELISA) with Treponema pallidum hemagglutination assay (TPHA) as a gold standard for the diagnosis of syphilis.

RESULTS

The sensitivity, specificity, and positive and negative predictive values of ECOTEST-RPR were 100%, 80.8%, 76.2%, and 100%, respectively. However, the sensitivity, specificity, and positive and negative predictive values of DIALAB-ELISA were 98.4%, 94.9%, 92.3%, and 98.9%, respectively. The agreement between DIALAB-ELISA and Randox-TPHA was excellent (kappa value: 0.96) as compared to ECOTEST-RPR and Randox-TPHA assay (kappa value: 0.88).

CONCLUSION

We found a characteristically variable performance of DIALAB-ELISA test and the currently available traditional ECOTEST-RPR test in the study area. The use of ECOTEST-RPR as a diagnostic test is confronted by its false positivity. Thus, neither the ECOTEST-RPR nor the DIALAB-ELISA test stands on its own to be used either as screening or confirmatory test for syphilis diagnosis. Consequently, thorough studies should be conducted aiming on a change of the current diagnostic scheme in the community.

Authors+Show Affiliations

Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, University of Gondar, Gondar, Ethiopia.Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, University of Gondar, Gondar, Ethiopia.Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, University of Gondar, Gondar, Ethiopia.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

30069486

Citation

Negash, Markos, et al. "Comparison of RPR and ELISA With TPHA for the Diagnosis of Syphilis: Implication for Updating Syphilis Point-of-Care Tests in Ethiopia." Journal of Immunology Research, vol. 2018, 2018, p. 2978419.
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.
Negash, M., Wondmagegn, T., & Geremew, D. (2018). Comparison of RPR and ELISA with TPHA for the Diagnosis of Syphilis: Implication for Updating Syphilis Point-of-Care Tests in Ethiopia. Journal of Immunology Research, 2018, 2978419. https://doi.org/10.1155/2018/2978419
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. PubMed PMID: 30069486.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of RPR and ELISA with TPHA for the Diagnosis of Syphilis: Implication for Updating Syphilis Point-of-Care Tests in Ethiopia. AU - Negash,Markos, AU - Wondmagegn,Tadelo, AU - Geremew,Demeke, Y1 - 2018/07/08/ PY - 2018/02/02/received PY - 2018/04/24/revised PY - 2018/05/27/accepted PY - 2018/8/3/entrez PY - 2018/8/3/pubmed PY - 2018/11/6/medline SP - 2978419 EP - 2978419 JF - Journal of immunology research JO - J Immunol Res VL - 2018 N2 - BACKGROUND: Syphilis is a sexually transmitted disease (STD) caused by the spirochete Treponema pallidum, and it persists to be a major public health problem in Africa, including Ethiopia. Syphilis diagnosis is made by either nontreponemal or treponemal approaches, though in developing countries the diagnosis relies mostly on nonspecific tests due to several reasons. Thus, the objective of this study was to assess the sensitivity, specificity, predictive values, and agreement of rapid plasma reagin (RPR) and enzyme-linked immunosorbent assay (ELISA) with Treponema pallidum hemagglutination assay (TPHA) as a gold standard for the diagnosis of syphilis. RESULTS: The sensitivity, specificity, and positive and negative predictive values of ECOTEST-RPR were 100%, 80.8%, 76.2%, and 100%, respectively. However, the sensitivity, specificity, and positive and negative predictive values of DIALAB-ELISA were 98.4%, 94.9%, 92.3%, and 98.9%, respectively. The agreement between DIALAB-ELISA and Randox-TPHA was excellent (kappa value: 0.96) as compared to ECOTEST-RPR and Randox-TPHA assay (kappa value: 0.88). CONCLUSION: We found a characteristically variable performance of DIALAB-ELISA test and the currently available traditional ECOTEST-RPR test in the study area. The use of ECOTEST-RPR as a diagnostic test is confronted by its false positivity. Thus, neither the ECOTEST-RPR nor the DIALAB-ELISA test stands on its own to be used either as screening or confirmatory test for syphilis diagnosis. Consequently, thorough studies should be conducted aiming on a change of the current diagnostic scheme in the community. SN - 2314-7156 UR - https://www.unboundmedicine.com/medline/citation/30069486/Comparison_of_RPR_and_ELISA_with_TPHA_for_the_Diagnosis_of_Syphilis:_Implication_for_Updating_Syphilis_Point_of_Care_Tests_in_Ethiopia_ L2 - https://doi.org/10.1155/2018/2978419 DB - PRIME DP - Unbound Medicine ER -