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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?{triangledown}

Sue Skidmore,1 Paddy Horner,2,3 Alan Herring,4,{dagger} Joanne Sell,5 Ian Paul,5 Jane Thomas,1 E. Owen Caul,4,{dagger} 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,{ddagger}

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.

* Corresponding author. Mailing address: Department of Social and Preventive Medicine, University of Bern, Finkenhubelweg 11, CH-3012, Bern, Switzerland. Phone: 41 31 631 3092. Fax: 41 31 631 3520. E-mail: low{at}ispm.unibe.ch.

{triangledown} Published ahead of print on 25 October 2006.

{dagger} Now retired.

{ddagger} See Acknowledgments for list of study group members.

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




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