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Journal of Clinical Microbiology, December 2006, p. 4389-4394, Vol. 44, No. 12
0095-1137/06/$08.00+0     doi:10.1128/JCM.01060-06

Vulvovaginal-Swab or First-Catch Urine Specimen To Detect Chlamydia trachomatis in Women in a Community Setting?

Sue Skidmore,¹ Paddy Horner,^2,3 Alan Herring,^4, Joanne Sell,⁵ Ian Paul,⁵ Jane Thomas,¹ E. Owen Caul,^4, Matthias Egger,^6,7 Anne McCarthy,⁶ Emma Sanford,⁶ Chris Salisbury,⁸ John Macleod,⁹ Jonathan A. C. Sterne,⁶ Nicola Low,^6,7* for the Chlamydia Screening Studies (ClaSS) Project Group,

Public Health Laboratory Service, Birmingham Laboratory, Birmingham B9 5SS, United Kingdom,¹ Department of Pathology and Microbiology, University of Bristol, Bristol, United Kingdom,² The Milne Centre, United Bristol Healthcare NHS Trust, Bristol BS2 8HW, United Kingdom,³ Public Health Laboratory Service Bristol Laboratory, Bristol BS2 8EL, United Kingdom,⁴ Health Protection Agency, Myrtle Road, Bristol BS2 8EL, United Kingdom,⁵ Department of Social Medicine, University of Bristol, Bristol BS8 2PR, United Kingdom,⁶ Department of Social and Preventive Medicine, University of Bern, Bern CH-3012, Switzerland,⁷ Department of Community-Based Medicine, University of Bristol, Bristol BS6 6JL, United Kingdom,⁸ Department of Primary Care, University of Birmingham, Birmingham B15 2TT, United Kingdom⁹

Received 22 May 2006/ Returned for modification 14 August 2006/ Accepted 9 October 2006

Screening for chlamydia in women is widely recommended. We evaluated the performance of two nucleic acid amplification tests for detecting Chlamydia trachomatis in self-collected vulvovaginal-swab and first-catch urine specimens from women in a community setting and a strategy for optimizing the sensitivity of an amplified enzyme immunoassay on vulvovaginal-swab specimens. We tested 2,745 paired vulvovaginal-swab and urine specimens by PCR (Roche Cobas) or strand displacement amplification (SDA; Becton Dickinson). There were 146 women infected with chlamydia. The assays detected 97.3% (95% confidence interval [CI], 93.1 to 99.2%) of infected patients with vulvovaginal-swab specimens and 91.8% (86.1 to 95.7%) with urine specimens. We tested 2,749 vulvovaginal-swab specimens with both a nucleic acid amplification test and a polymer conjugate-enhanced enzyme immunoassay with negative-gray-zone testing. The relative sensitivities obtained after retesting specimens in the negative gray zone were 74.3% (95% CI, 62.8 to 83.8%) with PCR and 58.3% (95% CI, 46.1 to 69.8%) with SDA. In community settings, both vulvovaginal-swab and first-catch urine specimens from women are suitable substrates for nucleic acid amplification tests, but enzyme immunoassays, even after negative-gray-zone testing, should not be used in screening programs.

Published ahead of print on 25 October 2006.

Now retired.

See Acknowledgments for list of study group members.

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