1. Department of Clinical Laboratory,Guangdong Provincial Corps Hospital of Chinese People’s Armed Police Forces,Guangzhou 510507,China;2. Department of Pharmaceutics, Logistics University of Chinese People’s Armed Police Forces,Tianjin 300162, China
Abstract:Objective To study the sensitivity and specificity of chemiluminescence microparticle immunoassay (CMIA) in detecting Treponema pallidum antibodies in serum specimens. Methods With TPPA as a control standard,4 686 serum samples collected from inpatients and outpatients at this hospital between February and May in 2011 were assayed by CMIA. Kappa test was applied to evaluate the consistency of the two detection methods on the same specimen. Results In the 4686 serum samples,the positive rate of CMIA and TPPA was 5.48% and 5.14% ,respectively. With TPPA as the relative standard method,the sensitivity and specificity of CMIA were 99.17%(239/241)and 99.60% (4427/4445), respectively. 214 of the 215 samples detected as S/CO>4.00 by CMIA were diagnosed as positive by TPPA,suggesting a positive predictive value(PPV)of 99.53% (214/215). Conclusions CMIA can replace TPPA in detecting Treponema Pallidum antibody. However, the positive results of S/CO value 1.0-4.0 in CMIA need to be re-examined to ensure the accuracy of test results.