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Clinic-based evaluation of Clearview Chlamydia MF for detection of Chlamydia trachomatis in vaginal and cervical specimens from women at high-risk in China
  1. Yue-Ping Yin (ypyinc{at}vip.163.com)
  1. National Center for STD Control, China
    1. Rosanna Peeling (peelingr{at}who.int)
    1. WHO Geneva, Switzerland
      1. Xiang-Sheng Chen (chenxs{at}vip.163.com)
      1. National Center for STD Control, China
        1. Kuang-Long Gong
        1. National Center for STD Control, China
          1. Hua Zhou
          1. Shenzhen Institute of Dermatology, China
            1. Wei-Ming Gu
            1. Shanghai Hospital for Dermatology and STDs, China
              1. He-Ping Zheng
              1. Guangdong Institute of Dermatology and Venereology, China
                1. Zheng-Sheng Wang
                1. Fujian Institute of Dermatology and Venereology, China
                  1. Gang Yong
                  1. Sichuang Institute of Dermatology and Venereology, China
                    1. Wen-Ling Cao
                    1. Guangzhou Institute of Dermatology and Venereology, China
                      1. Mei-Qin Shi
                      1. National Center for STD Control, China
                        1. Wan-Hui Wei
                        1. National Center for STD Control, China
                          1. Xiu-Qin Dai
                          1. National Center for STD Control, China
                            1. Xing Gao
                            1. National Center for STD Control, China
                              1. Qiang Chen
                              1. National Center for STD Control, China
                                1. David Mabey (david.mabey{at}lshtm.ac.uk)
                                1. London School of Hygiene and Tropical Diseases, United Kingdom

                                  Abstract

                                  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 1,497 women at STD clinics or reeducation centers in 6 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 randomized 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<0.001). There was good agreement between the results read by 2 independent staff for either vaginal or cervical specimens (both Kappa=0.98, P<0.001). Sensitivities for vaginal and cervical specimens were 32.8% and 49.7%, respectively; and specificities were 99.2% and 97.9%, respectively. The positive predictive value was 85.7% for vaginal and 78.4% for cervical specimens. The vast majority of the patients (99.1%) were willing to wait up to 2 hours for the results.

                                  Conclusion: Clearview Chlamydia MF, while yielding a rapid result and requiring minimal laboratory facilities, had unacceptably low sensitivity compared to a nucleic acid amplification test. Rapid tests yielding results within one hour are generally accepted by the clients.

                                  • China
                                  • Chlamydia trachomatis
                                  • Clearview Chlamydia MF
                                  • Women at high-risk

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