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目的评价改良免疫层析法在泌尿生殖道沙眼衣原体(CT)感染的检测质量,探讨其临床应用价值。方法运用改良免疫层析法试剂盒(简称chemtrue-CT)对3家医院的261例性病门诊和健康体检者进行检测,同时以聚合酶链反应(PCR)试剂盒(简称PCR-CT)检测作为标准,分析chemtrue-CT的检测性能。结果chemtrue-CT阳性率21.8%,PCR-CT阳性率28.4%,PCR-CT阳性率高于chemtrue-CT(P<0.01)。chemtrue-CT敏感性和特异性分别是75.7%和99.5%,总体符合率92.7%。其中男性组2种方法总符合率88.8%,阳性率差异有统计学意义(P<0.01);女性组2种方法总符合率为97.4%,阳性率差异无统计学意义(P>0.05);女性中高危人群和健康人群2种试剂检测总符合率分别为96.8%和98.2%。结论改良衣原体免疫层析法与PCR之间的检测差异正在缩小,尤其对女性人群的检测性能接近PCR。
Objective To evaluate the quality of detection of genital C. trachomatis (CT) infection by modified immunochromatography and to explore its clinical value. Methods A total of 261 STD clinics and healthy volunteers in three hospitals were tested by modified immunochromatography kit (referred to as chemtrue-CT), and detected by polymerase chain reaction (PCR) kit (PCR-CT) Standard, analysis of chemtrue-CT detection performance. Results The positive rate of chemtrue-CT was 21.8%. The positive rate of PCR-CT was 28.4%. The positive rate of PCR-CT was higher than that of chemtrue-CT (P <0.01). The sensitivity and specificity of chemtrue-CT were 75.7% and 99.5%, respectively. The overall coincidence rate was 92.7%. The coincidence rate of the two methods in male group was 88.8%, the positive rate was statistically significant (P <0.01). The coincidence rate of the two methods in female group was 97.4%, the positive rate was no significant difference (P> 0.05). The total coincidence rates of the two reagents in women at high risk and healthy population were 96.8% and 98.2% respectively. Conclusion The difference between the modified Chlamydia immunochromatography and PCR is narrowing, especially for the female population.