Evaluation of SD BIOLINE Syphilis 3.0 for syphilis diagnosis

Abstract

The SD BIOLINE Syphilis 3.0 was created by principle of immunochromatography which coated with recombinant Treponema pallidum antigens (TpN15, TpN17 and TpN47) on nitrocellulose membrane in cassette strip test to use for syphilis diagnosis. The objective of this study was to evaluate the sensitivity and specificity of the SD BIOLINE Syphilis 3.0. Ninety samples, previously tested by Treponema pallidum particle agglutination test (TPPA) including 52 positive samples and 38 negative samples were studied. As compared to the TPPA test, the sensitivity and specificity of SD BIOLINE Syphilis 3.0 were 90.4 % and 100 %, respectively. The agreement by Kappa (K) analysis showed almost perfect correlation (K = 0.887) between the two methods. Therefore, it is concluded that the SD BIOLINE Syphilis 3.0 is an alternative test with acceptably high sensitivity and specificity for detection of Treponema pallidum antibody. It is easy to use without any special laboratory equipment.