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Sexually Transmitted Diseases:
doi: 10.1097/OLQ.0000000000000125
Original Study

Evaluation of a New APTIMA Specimen Collection and Transportation Kit for High-Risk Human Papillomavirus E6/E7 Messenger RNA in Cervical and Vaginal Samples

Chernesky, Max PhD*; Jang, Dan BSc*; Gilchrist, Jodi MSc*; Elit, Laurie MD; Lytwyn, Alice MD; Smieja, Marek MD, PhD*; Dockter, Janel BSc‡§; Getman, Damon PhD‡§; Reid, Jennifer PhD‡§; Hill, Craig PhD‡§

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Abstract

Background

An APTIMA specimen collection and transportation (SCT) kit was developed by Hologic/Gen-Probe.

Objectives

To compare cervical SCT samples to PreservCyt and SurePath samples and self-collected vaginal samples to physician-collected vaginal and cervical SCT samples. To determine ease and comfort of self-collection with the kit.

Study Design

Each woman (n = 580) self-collected a vaginal SCT, then filled out a questionnaire (n = 563) to determine ease and comfort of self-collection. Colposcopy physicians collected a vaginal SCT and cervical PreservCyt, SCT, and SurePath samples. Samples were tested by APTIMA HPV (AHPV) assay.

Results

Agreement between testing of cervical SCT and PreservCyt was 91.1% (κ = 0.82), and that of SurePath samples was 86.7% (κ = 0.72). Agreement of self-collected vaginal SCT to physician-collected SCT was 84.7% (κ = 0.68), and that of self-collected vaginal to cervical SCT was 82.0% (κ = 0.63). For 30 patients with CIN2+, AHPV testing of cervical SCT was 100% sensitive and 59.8% specific compared with PreservCyt (96.6% and 66.2%) and SurePath (93.3% and 70.9%). Vaginal SCT sensitivity was 86.7% for self-collection and 80.0% for physician collection. Most patients found that vaginal self-collection was easy, 5.3% reported some difficulty, and 87.6% expressed no discomfort.

Conclusions

Cervical samples collected with the new SCT kit compared well to traditional liquid-based samples tested by AHPV. Although there was good agreement between self-collected and physician-collected samples with the SCT, in a limited number of 30 women, vaginal sampling identified fewer with CIN2+ precancerous cervical lesions than cervical SCT sampling. Comfort, ease of use, and detection of high-risk HPV demonstrated that the kit could be used for cervical and vaginal sampling.

Copyright © 2014 American Sexually Transmitted Diseases Association All rights reserved.

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