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

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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.