金标快速免疫试剂盒检测沙眼衣原体的性能评估

目的　对目前最常用的两种胶体金标记快速免疫试验检测泌尿生殖道标本中沙眼衣原体的结果进行临床评估。方法　共检测临床标本 188例 ,包括男性尿道拭子标本 5 2例 ,女性宫颈拭子标本 136例。每例患者取拭子三支。前两支拭子标本分别用于两种金标快速试验 (“英国立明”及“美国思创”)。拭子使用顺序在每隔 10例患者后作一交替。第三支拭子用于酶免法 (“Dako酶免”)检测。结果　以酶免法结果为参照 ,两种金标法对男性标本的敏感性分别为“英国立明”5 8.33% ,“美国思创”为 6 6 .6 7% ;对女性患者的敏感性分别为“英国立明”85 .2 9% ,“美国思创”82 .35 %。综合男女标本的检测结果 ,敏感性分别为“英国立明”78.2 6 % ,“美国思创”78.2 6 % ;特异性分别为 92 .96 %、94 .37%。结论　两种金标类试剂检测结果之间差异无显著性 ,其敏感性均较低 ,尤其是对男性尿道拭子标本的漏检率较高

Comparison of ELISA and two rapid immuno assays for the detection of chlamydia trachomatis in urogenital specimens

Objective To evaluate the performance characteristics of two rapid immunoassay kits (Clearview and StrongStep) and an antigen detection ELISA kit (IDEIA PCE) for the detection of chlamydia trachomatis in urogenital specimens. Methods 188 specimens were collected from 52 men and 136 women. Three urethral swabs for male and three endocervical swabs for female were collected from each patient. The first and the second swabs were tested by Clearview or StrongStep IDEIA PCE was performed on the third swabs. Results The relative sensitivities for the Clearview and the StrongStep assays with male urethral swabs were 58.33% and 66.67%, with endocervical swab specimens were 85.29% and 82.35% respectively. Overall sensitivety and specificity of Clearview were 78.26% and 92.96% respectively, of the StrongStep were 78.26% and 94.37% respectively. Conclusion Clearview and StrongStep, had unacceptably low sensitivity for male urethral swab specimens. IDEIA PCE kit performed well, particularly for urethral swab specimens from men.