快速梅毒螺旋体抗体检测试验的实验室初步评价

Laboratory Evaluation of Rapid Test for Treponema Pallidum Antibodies

目的：对不同国家生产的7种快速梅毒螺旋体抗体检测试验效果进行实验室评价，筛选敏感、特异、快速、简便、价廉的快速特异性梅毒螺旋体抗体检测方法。方法：以世界卫生组织推荐的TPPA方法作为“金标准”，采用盲法，分别对92份TPPA阳性血清和阴性血清进行快速试验检测，检测结果由2位观察人员分别判读纪录，并在第一次判读结果后1小时读取第二次结果，以评价7种快速试验的敏感性、特异性、结果判读的一致性以及稳定性等。结果：7种快速试验的敏感性为70．8％～97．9％，其中三种快速试验的敏感性较高，与另外四种试验方法比较有统计学差异；7种方法的特异性为89％～95％，各方法之间均无统计学差异；所有结果判读的一致性及稳定性都很高。结论：实验室对7种快速特异性梅毒螺旋体抗体检测试验效果的实验室评价结果表明：Determine（Abbott，美国）及Bioline（Standard，韩国）有较高的敏感性和特异性，且操作简便、相对价廉，可望作为理想的梅毒螺旋体抗体快速检测试剂推广应用。

Objective：To evaluate 7 rapid tests for Treponema Pallidum antibodies in laboratory. Methods：Seven rapid treponemal tests were performed in 92 serum samples from our outpatient clinics. Results of tests were read and recorded separately by two persons, with an interval of one hour between two readings. Sensitivity and specificity of these seven tests were determined by comparison with results from Treponema Pallidum Particle Agglutination Assays （TPPA）. Results： Sensitivities of these seven rapid tests were found to be ranged from 70. 8% to 97. 9%, the specificities were from 89% to 95%. All test showed reasonable reliability and were easy to be carried out in clinical laboratory settings. Conclusion：Results of this study showed that out of seven tests examined, Determine （Abbott, USA） and Bioline （Standard, Korea） meet clinical criteria to obtain fast diagnosis of syphilis in clinics.