Published 28 July 2009, doi:10.1136/bmj.b2655
Cite this as: BMJ 2009;339:b2655

Research

Performance evaluation of a new rapid urine test for chlamydia in men: prospective cohort study

¹ Diagnostics for the Real World (Europe), Cambridge Science Park, Cambridge CB4 0WG, ² Departments of Genitourinary Medicine and Virology, Barts and The London NHS Trust, London E1 1BB, ³ University of Cambridge, Department of Haematology, Diagnostics Development Unit, NHS Blood and Transplant Site, Cambridge CB2 2PT, ⁴ Brook in Birmingham, Birmingham B1 1BL, ⁵ Sexually Transmitted Bacteria Reference Laboratory, Health Protection Agency Centre for Infections, London NW9 5HT

Objective To evaluate the performance of a rapid test for chlamydia with first void male urine samples as a potential tool for diagnosis and screening of chlamydial infection in men.

Design Evaluation of test performance in prospective cohort study.

Settings A young people’s sexual health centre (site 1) and a genitourinary medicine clinic (site 2) in the United Kingdom.

Participants 1211 men aged 16-73 attending either of the two sites.

Main outcome measures Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction assay. Relation between the visual signal of the Chlamydia Rapid Test and organism load.

Results Detection rates for Chlamydia trachomatis infection with polymerase chain reaction were 4.4% (20/454) at site 1 and 11.9% (90/757) at site 2. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test was 82.6% (90/109), 98.5% (1085/1102), 84.1% (90/107), and 98.3% (1085/1104), respectively. The organism load in first void urine samples that were positive for chlamydia ranged from 7.28x10² to 6.93x10⁶ plasmids/ml and correlated significantly with the visual signal of the Chlamydia Rapid Test (r=0.7897, P<0.001).

Conclusions The performance of the new Chlamydia Rapid Test with first void male urine samples indicates that it would be an effective diagnostic tool for chlamydial infection in men. The availability of test results within an hour allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. The test could also provide a simple and reliable alternative to nucleic acid amplification assays for testing of male urine in chlamydial screening programmes in high prevalence settings.

© Nadala et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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