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.
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.
Chernesky
Max
M
St. Joseph's Healthcare/McMaster University, 50 Charlton Avenue East, Hamilton, Ontario, Canada. chernesk@mcaster.ca
Jang
Dan
D
Smieja
Marek
M
Portillo
Eder
E
Ewert
Ruth
R
Pritchard
Cindy
C
MacEachern
Diane
D
Doucette
Christine
C
MacDonald
Anne
A
Kapala
Julius
J
Sumner
Jeff
J
Hill
Craig
C
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*
D003470:Culture Media; D011933:Reagent Kits, Diagnostic