Multicenter comparative evaluation of two rapid immunoassay methods for the detection of Chlamydia trachomatis antigen in endocervical specimens.

OBJECTIVE: To evaluate two rapid immunoassay methods, QuickVue-Chlamydia (Quidel Corp., San Diego California) and Kodak SureCell (Kodak Corp., Rochester, NY) for the detection of Chlamydia trachomatis antigen in endocervical swabs from high- and low-risk females. METHODS: Seven hundred and twenty-four females attending three clinics were enrolled in the study. The results were compared to McCoy's or BGMK cell culture and discrepancies resolved with polymerase chain reaction and direct fluorescent antibody tests performed on left-over culture specimens. RESULTS: The sensitivity, specificity, predictive value of a positive and predictive value of a negative of the QuickVue Chlamydia assay were 92.0%, 99.1%, 92.0% and 99.1%, respectively. The sensitivity, specificity, predictive value of a positive and predictive value of a negative of the SureCell assay were 90.0%, 99.8%, 98.6% and 98.8%, respectively. CONCLUSIONS: The performances of the two immunoassay methods were similar, and slight differences in sensitivity and specificity were not statistically significant. Both immunoassay methods performed well in high- and low-risk patient groups, both for symptomatic and for asymptomatic patients.