The APTIMA COMBO 2 assay, which detects and amplifies rRNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae, is approved for use on ThinPrep liquid-based Pap test specimens. The objective was to determine the clinical utility of the APTIMA assays (APTIMA COMBO 2 assay, APTIMA CT assay for Chlamydia trachomatis, and APTIMA GC assay for Neisseria gonorrhoeae) for screening women during their annual Pap exam, using SurePath liquid-based Pap test specimens. Two cervical samples were collected from 1,615 females attending six clinical sites in North America. A cervical broom sample was processed for cytology, with the residuum aliquoted into an APTIMA specimen transfer kit tube. The second cervical swab sample was put into APTIMA specimen transport medium, and both samples were tested with each APTIMA assay on a direct sampling system. Using a subject-infected status that utilized cervical-swab specimen results from two APTIMA assays, the prevalence was 7.9% for Chlamydia trachomatis and 2.5% for N. gonorrhoeae. Annual screening for cervical abnormalities using a Pap test has resulted in a substantial reduction in morbidity and mortality from cervical cancer (11). There are three liquidbased Pap tests (LPTs) approved by the United States Food and Drug Administration (FDA): PreservCyt ThinPrep (Cytyc, Boxborough, MA), SurePath (TriPath Care Technologies, Burlington, NC), and Cytotek MonoPrep (Monogen, Inc., Vernon Hills, IL). Liquid-based cytology has provided greater Pap testing accuracy, and the sample may serve as a specimen to test for infectious agents, such as human papillomavirus (2, 11), Chlamydia trachomatis (5, 14), and Neisseria gonorrhoeae (6, 9). The APTIMA COMBO 2 assay, APTIMA CT assay for Chlamydia trachomatis, and AP-TIMA GC assay for Neisseria gonorrhoeae are transcriptionmediated amplification tests that utilize target capture specimen processing for the in vitro qualitative detection of rRNA from C. trachomatis and/or N. gonorrhoeae. The assays are approved for use on cervical swab (CS) samples, vaginal swab samples, urethral swab samples, and first-catch urine samples. The APTIMA COMBO 2 assay is approved for use with ThinPrep LPT specimens. A limited number of studies have been published using both amplified and nonamplified tests for C. trachomatis or N. gonorrhoeae in liquid-based specimens and have concentrated on the use of ThinPrep samples (1, 5-10; D. Fuller, T. Davis, and J. Talbott, unpublished data). Our objective was to determine the clinical utility of the APTIMA assays (Gen-Probe Incorporated) for screening women for C. trachomatis and N. gonorrhoeae during their annual Pap examination by using SurePath LPT specimens.
MATERIALS AND METHODSA total of 1,615 female subjects signed consent forms while being enrolled during 2004 at six clinical sites in North America: University of North Carolina (UNC), Chapel Hill, NC; University of Alabama (UAB), Birmingham, AL; St. Joseph's Healthcare (SJH), Hamilton, ON, Canada; University of OklahomaTulsa (UOT), Tulsa, OK; University of Illinoi...