[国产化学发光免疫分析试剂盒检测梅毒螺旋体抗体的性能评价]
[Performance evaluation of TP antibody detection by CLIA kits made (in China) domestically].
作者信息
Jiang Yu-Qing, Xie Zhi-Xian, Fang Wen-Dan, Liu Tianyi
机构信息
Department of Laboratory Medicine, Beijing Hospital, Beijing 100730, China.
出版信息
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2013 Aug;27(4):307-9.
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.
目的
分析化学发光免疫分析法（CLIA）试剂盒检测梅毒螺旋体（TP）抗体的临床性能，并评估国产CLIA试剂盒是否适合临床应用。
方法
从北京医院收集1200份样本，其中包括300份确诊TP感染的样本和900份健康对照样本。同时采用CLIA试剂盒和酶联免疫吸附测定（ELISA）试剂盒分别检测这1200份样本的TP抗体。采用统计学方法分析检测结果。
结果
CLIA试剂盒的灵敏度和特异性分别为99.3%和99.9%，阳性预测值为99.7%，阴性预测值为100%。ELISA法的阳性符合率为98.7%，阴性符合率为99.8%，总符合率为99.5%。
结论
CLIA试剂盒显示出良好的临床性能，与ELISA试剂盒的符合率高。CLIA试剂盒适合临床使用。
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