Evaluation of an improved immuno-chromatographic assay to detect chlamydia trachomatis in genitourinary tract infection

Abstract

Abstract:

Objective　To evaluate the performance of an improved immuno-chromatographic assay for the detection of chlamydia trachomatis（CT） in genitourinary tract infection， and then to assess the significance of clinical application. Methods　A total of 261 patients from sexually transmited infection clinics and healthy subjects in 3 hospitals of Shanghai were enrolled and determined by an improved immuno-chromatographic assay kit（chemtrue-CT）. The polymerase chain reaction（PCR） kit（PCR-CT） as a reference standard was used to analyze the performance of chemtrue-CT. Results　The total positive rate of PCR-CT（28.4%） was higher than that of chemtrue-CT（21.8%， P＜0.01）. The sensitivity and specificity of chemtrue-CT were 75.7% and 99.5%， respectively. The overall coincidence rate between
the 2 assays was 92.7% with male group's coincidence rate 88.8%（P＜0.01） and female group's coincidence rate 97.4%（P＞0.05）. The 2 assay resultswere similar with an overall coincidence rate of 96.8% and 98.2% in female group. Conclusions　The performance difference between chemtrue-CT and PCR-CT is narrowing. Particularly for female group， chemtrue-CT shows acceptable performance in comparison with PCR-CT.

Key words: Immuno-chromatographic assay, Polymerase chain reaction, Methodology evaluation, Chlamydia

CLC Number:

R446.11

WU Lei, YANG Yang, TANG Zhenhua, ZHANG Qiangqiang, LU Tingyan, JIN Yuelan, HU Weizhong, XU Ming, GU Weiming. Evaluation of an improved immuno-chromatographic assay to detect chlamydia trachomatis in genitourinary tract infection[J]. , 2014, 29(12): 1226-1229.

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