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Journal of Clinical Microbiology, August 2003, p. 3784-3789, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3784-3789.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Vaginal Swabs Are Appropriate Specimens for Diagnosis of Genital Tract Infection with Chlamydia trachomatis

Julius Schachter,1* William M. McCormack,2 Max A. Chernesky,3 David H. Martin,4 Barbara Van Der Pol,5 Peter A. Rice,6 Edward W. Hook III,7 Walter E. Stamm,8 Thomas C. Quinn,9 and Joan M. Chow1,10

Department of Laboratory Medicine,1 Department of Obstetrics Gynecology and Reproductive Sciences, University of California, San Francisco, California,10 Department of Medicine, State University of New York Downstate Medical Center, Brooklyn, New York,2 McMaster University, Saint Joseph's Healthcare, Hamilton, Ontario, Canada,3 School of Medicine, Louisiana State University, New Orleans, Louisiana,4 Infectious Diseases Division, Indiana University School of Medicine, Indianapolis, Indiana,5 Maxwell Finland Laboratory for Infectious Diseases, Boston City Hospital, Boston, Massachusetts,6 Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama,7 Department of Medicine, University of Washington, Seattle, Washington,8 Johns Hopkins University, Baltimore, Maryland9

Received 20 February 2003/ Returned for modification 30 March 2003/ Accepted 14 April 2003

Because self-collected vaginal swabs (VS) are potentially very useful for screening asymptomatic women for Chlamydia trachomatis infection, a multicenter study evaluated that specimen with nucleic acid amplification tests (NAATs). The objective was to determine whether VS are equal to Food and Drug Administration (FDA)-cleared specimens (cervical swabs and first-catch urines [FCU]) for diagnosing genital chlamydial infection. All NAATs then commercially available (October 1996 to October 1999) were used (ligase chain reaction [LCx Probe System; Abbott Laboratories, Abbott Park, Ill.]; PCR [Amplicor; Roche Molecular Systems, Branchburg, N.J.]; and transcription-mediated amplification, [Amplified CT Assay; Gen-Probe Inc., San Diego, Calif.]). NAATs were performed on FCU, urethral, cervical, self- and clinician-collected VS. Sensitivity was compared to isolation using cervical and urethral swabs. Agreement of NAAT results between VS and cervical swabs or FCU was calculated. Specimens from 2,517 15- to 25-year-old asymptomatic women attending clinics at nine different centers were evaluated. Results with self- and clinician-collected VS were equivalent and were at least as good as results with FCU and cervical swabs. Across all sites, summary specificities for all specimens were >99%. Among culture-positive women, NAAT sensitivity with VS (93%) was as high as or higher than NAAT sensitivity with cervical swabs (91%) or FCU (80.6%) or culture of cervical swabs (83.5%). VS are appropriate specimens for diagnosing chlamydial genital tract infection by NAATs. That patients can efficiently collect them offers important benefits for screening programs. It would be beneficial for public health programs if the NAAT manufacturers sought FDA clearance for this specimen.

* Corresponding author. Mailing address: Chlamydia Research Laboratory, Department of Laboratory Medicine, University of California, San Francisco, 1001 Potrero Ave., SFGH 3416, San Francisco, CA 94110. Phone: (415) 824-5115. Fax: (415) 821-8945. E-mail: jsch{at}itsa.ucsf.edu.

Journal of Clinical Microbiology, August 2003, p. 3784-3789, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3784-3789.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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