Performance evaluation of TP antibody detection by CLIA kits made (in China) domestically
10.3760/cma.j.issn.1003-9279.2013.04.022
- VernacularTitle:国产试剂化学发光法检测梅毒螺旋体抗体的临床评价
- Author:
Yu-Qing JIANG
1
;
Zhi-Xian XIE
;
Wen-Dan FANG
;
Tianyi LIU
Author Information
1. 卫生部北京医院检验科
- Keywords:
Syphilis;
Syphilis serodiagnosis;
Chemiluminescence;
Enzyme-linked immunosorbent assay
- From:
Chinese Journal of Experimental and Clinical Virology
2013;27(4):307-309
- CountryChina
- Language:Chinese
-
Abstract:
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.
