Sexually Transmitted Diseases

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Sexually Transmitted Diseases:
doi: 10.1097/OLQ.0b013e3181a4c3fc

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

Chernesky, Max PhD*; Jang, Dan BSc*; Smieja, Marek MD*; Portillo, Eder BSc*; Ewert, Ruth RN†; Pritchard, Cindy RN‡; MacEachern, Diane RN‡; Doucette, Christine MLA§; MacDonald, Anne MLT§; Kapala, Julius PHD§; Sumner, Jeff MSc§; Hill, Craig PHD∥

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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.

© Copyright 2009 American Sexually Transmitted Diseases Association


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