金标法快速梅毒血清检测的评价

The evaluation of immunochromatographic strip rapid test for the detection of syphilis

目的评价金标抗密螺旋体抗体胶体金快速检测试剂盒(SD syphilis 3.0)检测梅毒螺旋体抗体的可行性。方法运用金标快速SD syphilis 3.0试验与血浆反应素环状卡片试验(TRUST)和梅毒螺旋体明胶颗粒凝集试验(TPPA)平行检测168份高危可疑梅毒血清。结果168份高危可疑梅毒血清中,金标快速SD syphilis3.0、TRUST、TPPA阳性检出率分别为66.08%(111/168)、61.91%(104/168)、69.05%(116/168);以TPPA结果为标准,金标快速SD syphilis 3.0试验的敏感性为93.97%(109/116),特异性为98.20%(109/111)。结论金标快速SD syphilis 3.0检测梅毒抗体操作简便,具有一定的敏感性和特异性,在排除假阳性假阴性情况下是现场检测或单个患者梅毒确诊值得推广的方法。

Objective To evaluate the feasibility of detecting the antibody to syphilis by the rapid immunochromatographic stripSD syphilis 3.0 kit. Methods 168 serum samples with high-risk and suspicious syphilis were detected parallelly by SD syphilis 3.0 kit,tolulized red unheated serum test（TRUST） and treponema pallidum particle assay（TPPA） test. Results Among the 168 serum samples,the positive rate of SD syphilis 3.0 kit,TRUST and TPPA were 66.08%（111/168）,61.91%（104/168） and 69.05%（116/168）,respectively.Considering the result of TPPA as a criterion,the sensitivity and the specificity of SD syphilis 3.0 kit were 93.97%（109/116）and 98.20%（109/111）. Conclusions The assay of the SD syphilis 3.0 kit is simple and easy to operate,with good sensitivity and specificity.It is useful in the point of care testing.