Dwi Rahayuningsih, NIM011418156301 and Aryati, - (2019) EVALUATION OF IMMUNOCHROMATOGRAPIC TEST USING Tp17 ANTIGEN FOR DETECTION OF TREPONEMAL ANTIBODY IN BLOOD DONORS. clinical Pathology and medical laboratory, 26 (1). pp. 1-128. ISSN 0854-4263

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Abstract

Syphilis transmission through blood transfusion urged the WHO to recommend a detection of treponemal antibody in blood donors. The treponemal antibody was identified to be formed against the membrane of lipoprotein antigen Tp15, Tp17, and Tp47 of T.pallidum. The Tp17 antigen may have an important role in the pathogenesis of syphilis. Evaluation of the CLIA method using Tp17 antigen showed a good diagnostic value. Currently, the immunochromatography test using Tp17 antigen is available but the diagnostic value has not been widely published. The aim of this study was to determine the diagnostic value of immunochromatographic test using Tp17 antigen for treponemal antibody detection in blood donors. A total of 100 serum samples with reactive (n=66) and non-reactive (n=34) treponemal antibody were screened by using ELISA and CLIA methods in the Blood Transfusion Units of Surabaya, Mojokerto, and Sidoarjo Indonesian Red Cross from May 2018-August 2018 and were examined for treponemal antibody with immunochromatographic test using Tp17 antigen (StandardTM Q Syphilis Ab, Standard Biosensor) and Fluorescent Treponemal Antibody Absorption /FTA-ABS (EUROIMMUN, AG) as the gold standard. Kappa Cohen analysis showed that there was moderate and significant concordance between immunochromatographic test using Tp17 and IgG anti-treponemal FTA-ABS (k = 0.477 p: 0.000). The anti-treponemal IgM was non-reactive in all samples with the sensitivity and specificity of 69.8% and 81%, respectively. The low sensitivity was possibly due to the use of a single antigen (Tp17) while the treponemal antibody was formed by Tp15, Tp17, and predominantly by Tp47 antigen. The others possibilities were the decreased anti-Tp17 IgG in donors after syphilis treatment and the use of different gold standard from other studies (FTA-ABS vs TPHA). Further study using routine TPHA as a confirmation test, Western Blot to determine the other antibodies than anti-Tp17, and non-treponemal test to determine the disease activity was needed.

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