Clinic-based evaluation of Clearview Chlamydia MF for detection of Chlamydia trachomatis 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 (...

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Bibliographic Details
Published in:Sexually transmitted infections 2006-12, Vol.82 (suppl 5), p.v33-v37
Main Authors: Yin, Y-P, Peeling, R W, Chen, X-S, Gong, K-L, Zhou, H, Gu, W-M, Zheng, H-P, Wang, Z-S, Yong, G, Cao, W-L, Shi, M-Q, Wei, W-H, Dai, X-Q, Gao, X, Chen, Q, Mabey, D
Format: Article
Language:English
Subjects:
Adult
Agreements
Asymptomatic
Cervix Uteri - microbiology
China
Chlamydia
Chlamydia Infections - diagnosis
Chlamydia trachomatis
Chlamydia trachomatis - isolation & purification
Female
Gynecology
Humans
Infections
Laboratories
Male
Patient Satisfaction
Point-of-Care Systems - standards
Rapid Diagnostics
Risk Factors
Sexually transmitted diseases
Statistical analysis
STD
Vagina
Vagina - microbiology
Womens health
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Summary: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
ISSN:1368-4973
1472-3263
DOI:10.1136/sti.2006.022475