Clinic-based evaluation of Clearview Chlamydia MF for detection of Chlamydia trachoatis in vaginal and cervical specimens from women at high risk in China.
Objectives: To determine the performance of a rapid Chlamydia trachomatis (CT) test (Clearview Chlamydia MF) compared to the current \"gold standard\" (Roche Amplicor CT assay) test, and to assess acceptability of the tests to patients. Methods: A total of 1497 women at sexually transmitted diseases (STD) clinics or re-education centres in six urban cities (Shanghai, Nanjing, Shenzhen, Guangzhou, Chengdu and Fuzhou) in China participated in the study. Three vaginal and three cervical swabs were collected from each participant. Rapid CT tests were performed locally on the first vaginal and cervical swabs and the results were read independently by two staff members. The second and third swabs were randomised for performing the Roche CT assay at the National STD Reference Laboratory. Acceptability of the rapid tests to patients was determined by asking patients in clinics about their willingness to wait for the results. Results: The prevalence of CT was 13.2% (197/1497), as determined by the Roche assay with cervical specimens. CT was detected in 78 vaginal and 127 cervical specimens by the rapid test and the positive rates determined with cervical specimens were significantly higher than those with vaginal specimens (p
Sexually Transmitted Infections (2006) 82 (Suppl. 5) v33-v37.[doi:10.1136/sti.2006.022475]