title: Validation of the APTIMA Combo 2 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in SurePath liquid-based pap test samples taken with different collection devices.
abstract: Mocked samples of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) diluted in SurePath liquid-based Pap (L-Pap) fluid were detected by the APTIMA Combo 2 assay to end points 10-fold greater than dilutions in specimen transport media. Pooled L-Pap clinical specimens yielded CT-positive results after storage at room temperature for 10 days. Based on an infected patient standard for comparison, cervical swabs, urine, and SurePath L-Pap test samples collected with a SurePath cervical broom or ThinPrep cytobrush from 520 women then tested by APTIMA Combo 2 assay, detected 25 (4.8%) with CT, 5 (1.0%) with (GC), and 3 (0.6%) with both. Percent sensitivities (80-84), specificities (99.8-100), positive (99.5-100) and negative (99.2-99) predictive values of SurePath L-Pap for CT were validated as similar to those reported in a previously published multicenter trial. All values for GC were 100%. One collection device was not significantly better than the other.
authors: St. Joseph's Healthcare/McMaster University, 50 Charlton Avenue East, Hamilton, Ontario, Canada. chernesk@mcaster.ca
authors: Max
authors: M
authors: Chernesky
authors: Dan
authors: D
authors: Jang
authors: Marek
authors: M
authors: Smieja
authors: Eder
authors: E
authors: Portillo
authors: Ruth
authors: R
authors: Ewert
authors: Cindy
authors: C
authors: Pritchard
authors: Diane
authors: D
authors: MacEachern
authors: Christine
authors: C
authors: Doucette
authors: Anne
authors: A
authors: MacDonald
authors: Julius
authors: J
authors: Kapala
authors: Jeff
authors: J
authors: Sumner
authors: Craig
authors: C
authors: Hill
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods; D002584:Cervix Uteri / Q000382:microbiology; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D003470:Culture Media; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D014626:Vaginal Smears / Q000379:methods*
chemical_list: D003470:Culture Media; D011933:Reagent Kits, Diagnostic