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Vidas CHL Assay in the Detection of Urogenital Chlamydia Trachomatis Infection

         

摘要

Objectives: To evaluate the Vidas Chlamydia(CHL)assay for detecting C.Trachomatis with swabs and first catch urine(FCU) specimens from STD patients and high risk populations. Methods: A total of 383 patients were tested with tissue culture (TC), Vidas CHL and polymerase chain reaction (PCR)for C.trachomatis on male and female swabs, with Vidas CHL testing male FCU specimens. CHL positive and equivocal results were confirmed with a blocking assay (CHB). True positive were defined as either TC positive, or TC negtive but CHL and PCR positive. The performance of TC, CHL and PCR were evaluated according to this expanded gold standard. Results: Compared with the expanded gold standard, 54 of the 232 male specimens were true positive results. For male swabs, TC, CHL and PCR had sensitivities of 90.7%, 96.3% and 94.4%, and specificities of 100%, 98.3% and 97.2%,respectively. Differences were not statistically significant. For male FCU specimens, CHL sensitivity and specificity were 83.3% and 98.3%; there was little difference between these results and that of matched swabs. Compared with the expanded gold standard, 28 of the 151 female swabs were true positive; TC, CHL and PCR had sensitivities of 82.1%, 100% and 96.4%, and specificities of 100%, 98.4% and 97.6%,respectively. The difference was also not significant. Conclusions: Vidas CHL assay is very sensitive and specific for C.trachomatis detection with swab specimens of male andfemale STD patients. For male FCU specimens, the assay also had high sensitivity and specificity. CHB may not be needed inthe routine detection of Chlamydia infections. Population swith higher incidence of C.trachomatis infection.

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