경쟁적 효소면역 측정법을 이용한 Treponema pallidum 항체 진단시약의 개발 및 평가

Development and Evaluation of a Competitive Enzyme Immunoassay for the Detection of Antibodies to Treponema pallidum

A competitive enzyme-linked immunosorbent assay(ELISA) for the detection of antibodies to Treponema pallidum(T.pallidum) was developed and evaluated. T.apllidum lysate was immobilized on the surface of microplate wells and horseradish peroxidase labeled human anti-T.pallidum lysate was immobilized on the surface of microplate wells and horseradish peroxidase labeled human anti-T.pallidum was prepared and used as a tracer. The performance of the competitive ELISA was evaluated by using different specimens. The competitive ELISA showed a sensitivity of 100% in a performance panel consisting of serum and plasma with anti-T.pallidum reactivity ranging from negative to strong positive by FTA-ABS test system and 120 plasma samples positive by TPHA. The specificity of the competitive ELISA was 100% in 1,200 plasma samples collected from healthy seronegative blood donors. These results suggest that the competitive ELISA provides an excellent assay method for the detection of antibodies to T.pallidum, and may be particularly useful for serological blood screening of syphilis.