国产试剂化学发光法检测梅毒螺旋体抗体的临床评价  

Performance evaluation of TP antibody detection by CLIA kits made （in China ） domestically

作　　者：蒋郁青[1] 谢志贤[1] 方雯丹[2] 刘添翼[1] 

机构地区：[1]卫生部北京医院检验科,北京100730 [2]中国人民解放军第一七五医院

出　　处：《中华实验和临床病毒学杂志》2013年第4期307-309,共3页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的对国产化学发光法试剂盒检测梅毒螺旋体抗体的检测进行临床评价。方法收集来自卫生部北京医院的血清样品共1200例，包括经临床确诊的梅毒患者血清300例，正常人血清900例。对标本分别用国产化学发光法试剂盒和国产酶联免疫吸附实验试剂盒同时测定梅毒螺旋体抗体，对结果进行统计学处理和分析，计算两种方法的特异性、灵敏度和临床符合率。结果对l临床确诊的血清样品检测结果表明，该试剂盒检测梅毒螺旋体抗体敏感度为99．3％，特异度为99．9％，阳性结果预测值为99．7％，阴性结果预测值100％。与ELISA法比较，两者阳性符合率98．7％，阴性符合率99．8％。总符合（有效）率为99．5％。结论国产CLIA试剂盒与ELISA试剂盒的临床符合率达到临床检测要求，可用于临床检测。Objective To analyze the clinical performance of TP antibody detection by CLIA kits and evaluate whether the CLIA kits made in China is suitable for clinical use. Methods 1200 samples were collected from Beijing Hospital including 300 samples with confirmed TP infection and 900 healthy control samples. To detect the TP antibody of the 1200 sanples separately by the CLIA kits and the ELISA kits at the same time. The test results were analyzed with statistical methods. Results The sensitivity and specificity of the CLIA kits were 99. 3% and 99.9% respectively, and positive predictive value of 99.7% , negative predictive value of 100%. With the ELISA method, the positive coincidence rate was 98.7% , the negative coincidence rate was 99.8% , and the total coincidence rate was 99.5%. Conclusion The CLIA kits showed good clinical performance and the agreement rate with the ELISA kits was. The CLIA kits are suitable for clinical use.

关 键 词：梅毒 梅毒血清诊断 化学发光 酶联免疫吸附测定 

分 类 号：R446.6[医药卫生—诊断学]