Evaluation of Wondfo Chlamydia Trachomatis Rapid Diagnostic Cassette Based on Nano-Gold Immunochromatography Gssay（GICA）

Abstract

This paper explains and demonstrates how to evaluate the sensitivity and specificity of wondfo chlamydia trachomatis rapid diagnostic cassette with GICA for detection of chlamydia trachomatis. 1026 genital specimens were collected from 630 females and 396 males.Two cassettes of wondfo and ClearView were used for the detection of Chlamydia trachomatis samples with blind detection simultaneously, inconsistent results by DFA. Sensitivity, specificity, positive predictive value and negative predictive value of wondfo cassette were analyzed. Out of 1026 samples detected, 83 were positive by both of wondfo and ClearView and 13 showed different results by wondfo and ClearView. Out of the 13 samples, the DFA confirmed 9 were positive. Therefore, 92 samples were truly positive and 934 were truly negative. The sensitivity, specificity, positive predictive value and negative predictive value of wondfo were 96.74% ,99.6% , 95.7% , 99.68%, respectively. The consistent rates of test results of the chlamydia trachomatis rapid diagnostic cassette , wondfo and ClearView, both were the same 98.64%. Of the three standard strains and two clinical strains of dilution test results showed that the sensitivity of wondfo slightly ClearView.The sensitivity and specificity of wondfo for the detection of Chlamydia trachomatis have the accept tability for clinical diagnostic and surveillance data.