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Journal of Clinical Microbiology, February 2005, p. 577-584, Vol. 43, No. 2
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.2.577-584.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Impact of Patient Characteristics on Performance of Nucleic Acid Amplification Tests and DNA Probe for Detection of Chlamydia trachomatis in Women with Genital Infections

Jeanne M. Marrazzo,^1* Robert E. Johnson,² Timothy A. Green,³ Walter E. Stamm,¹ Julius Schachter,⁴ Gail Bolan,⁵ Edward W. Hook III,⁶ Robert B. Jones,⁷ David H. Martin,⁸ Michael E. St. Louis,² and Carolyn M. Black³

Department of Medicine, University of Washington, Seattle, Washington,¹ Division of STD Prevention, National Center for HIV, STD, and TB Prevention,² National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia,³ Department of Laboratory Medicine, University of California,⁴ San Francisco Department of Public Health, San Francisco, California,⁵ Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama,⁶ School of Medicine, Indiana University, Indianapolis, Indiana,⁷ School of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana⁸

Received 12 July 2004/ Returned for modification 29 August 2004/ Accepted 18 October 2004

The performance of nucleic acid amplified tests (NAAT) for Chlamydia trachomatis at the cervix and in urine was examined in 3,551 women, and the impacts of clinical findings (age, endocervical and urethral inflammation, menses, and gonococcal coinfection) were assessed. Ligase chain reaction (LCR) and first-generation uniplex PCR were studied relative to an unamplified DNA probe (PACE2) and to an expanded, independent diagnostic reference standard. Relative to the expanded standard, cervical or urine LCR was generally the most sensitive test in most subgroups. Increased detection by NAAT of cervical C. trachomatis over PACE2 was highest among women without mucopurulent endocervical discharge versus those with (relative increase in positivity with cervical LCR, 46%) and among women 20 years old versus younger women (relative increase in positivity with cervical LCR, 45%). The sensitivity of cervical PCR was highest when mucopurulent endocervical discharge was present (84%) and highest for cervical LCR when cervical gonococcal coinfection was detected (91%). Urethral inflammation was associated with higher sensitivities of urine LCR (86 compared to 70% when inflammation was absent) and PCR (82 compared to 62% when inflammation was absent). Menses had no effect on test performance. The effects of patient characteristics on test specificities were less pronounced and were closely related to observed sensitivities. These findings support expanded use of NAAT for screening and diagnosis of C. trachomatis in diverse clinical populations of women.

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* Corresponding author. Mailing address: MPH, Harborview Medical Center, Division of Infectious Diseases, 325 Ninth Ave., Mailbox 359931, Seattle, WA 98104. Phone: (206) 731-3679. Fax: (206) 731-3693. E-mail: jmm2{at}u.washington.edu.

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Journal of Clinical Microbiology, February 2005, p. 577-584, Vol. 43, No. 2
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.2.577-584.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

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