Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2007 Dec 8;335(7631):1190-4.
doi: 10.1136/bmj.39402.463854.AE. Epub 2007 Nov 30.

New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study

Lourdes Mahilum-Tapay  1 , Vivian Laitila, James J Wawrzyniak, Helen H Lee, Sarah Alexander, Catherine Ison, Alison Swain, Penelope Barber, Ines Ushiro-Lumb, Beng T Goh
Affiliations
Multicenter Study

New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study

Lourdes Mahilum-Tapay et al. BMJ. .

Abstract

Objective: To evaluate the performance of a new Chlamydia Rapid Test with vaginal swab specimens as a potential tool for chlamydia diagnosis and screening.

Design: Performance evaluation study. Settings A young people's sexual health centre (site 1) and two genitourinary medicine clinics (sites 2 and 3) in the United Kingdom.

Participants: 1349 women aged between 16 and 54 attending one of the three clinics.

Main outcome measures: Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction and strand displacement amplification assays; correlation between the Chlamydia Rapid Test visual signal and organism load; acceptability to participants of self collected vaginal swabs as the specimen type for Chlamydia testing.

Results: Polymerase chain reaction positivity rates for Chlamydia trachomatis infection were 8.4% (56/663) at site 1, 9.4% (36/385) at site 2, and 6.0% (18/301) at site 3. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test were 83.5% (91/109), 98.9% (1224/1238), 86.7% (91/105), and 98.6% (1224/1242). Compared with strand displacement amplification assay, sensitivity and specificity of the Chlamydia Rapid Test were 81.6% (40/49) and 98.3% (578/588). Organism load of self collected vaginal swabs ranged from 5.97x10(2) to 1.09x10(9) Chlamydia plasmids per swab, which correlated well with the Chlamydia Rapid Test's visual signal (r=0.6435, P<0.0001). Most (95.9%) surveyed participants felt comfortable about collecting their own swabs.

Conclusions: The performance of the Chlamydia Rapid Test with self collected vaginal swabs indicates that it would be an effective same day diagnostic and screening tool for Chlamydia infection in women. The availability of Chlamydia Rapid Test results within 30 minutes allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. It could also provide a simple and reliable alternative to nucleic acid amplification tests in chlamydia screening programmes.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JJW and HHL are equity holders of a spin-off company, Diagnostics for the Real World, based on the rapid test technologies developed at the University of Cambridge. Both the University of Cambridge and the Wellcome Trust are also equity holders of the company.

Figures

None
Fig 1 Recruitment and testing algorithm for study participants. CCVS=clinician collected vaginal swab specimens; CRT=Chlamydia Rapid Test; PC=procedural control; PCR=polymerase chain reaction; SDA=strand displacement amplification assay; SCVS=self collected vaginal swab specimens
None
Fig 2 Chlamydia trachomatis (CT) organism load by quantitative polymerase chain reaction (qPCR; plasmids/swab) (n=33, r=0.644, P<0.0001). CRT=Chlamydia Rapid Test
See this image and copyright information in PMC

Comment in

References

    1. Cates W, Wasserheit JN. Genital chlamydial infections: epidemiology and reproductive sequelae. Am J Obstetr Gynecol 1991;164:1771-81. - PubMed
    1. Paavonen J, Lehtinen M. Chlamydial pelvic inflammatory disease. Hum Reprod Update 1996;2:519-29. - PubMed
    1. Gaydos CA, Theodore M, Dalesio N, Wood BJ, Quinn TC. Comparison of three nucleic acid amplification tests for detection of Chlamydia trachomatis in urine specimens. J Clin Microbiol 2004;42:3041-5. - PMC - PubMed
    1. National Chlamydia Screening Programme Steering Group. New frontiers: annual report of the national chlamydia screening programme in England 2005/06 London: Health Protection Agency, 2006. (available at www.hpa.org.uk/publications/2006/ncsp/).
    1. Davies SC, Otto B, Partohudoyo S, Chrisnadarmani VAMA, Neilsen GA, Ciaffi L, et al. Sexually transmitted infections among female sex workers in Kupang, Indonesia. Sex Transm Dis 2003;30:671-9. - PubMed

Publication types