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‡§

Sexually Transmitted Diseases: June 2014 - Volume 41 - Issue 6 - p 365–368
doi: 10.1097/OLQ.0000000000000125
Original Study

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.

A new APTIMA Specimen Collection and Transportation kit compared well to liquid-based Pap from 580 women tested by APTIMA HPV. Self-collected vaginal sampling with the kit was easy and comfortable for most.

From the *St Joseph’s Healthcare, Hamilton, Ontario, Canada; †Juravinski Hospital, Hamilton, Ontario, Canada; ‡McMaster University, Hamilton, Ontario, Canada; and §Hologic/Gen-Probe, San Diego, CA

Acknowledgments: The authors thank Ramandeep Toor and Joan Randazzo for their involvement in patient recruitment for this study.

Funding: This study was funded by Hologic/GenProbe Inc.

Competing interests: M.C. received support to present data related to this study. J.D., D.G., J.R., and C.H. are all paid employees of Hologic/GenProbe Inc.

Ethical approval: This study was approved by the St Joseph’s Healthcare and Hamilton Health Sciences Ethics Boards (REB No. 09-550).

Correspondence: Max Chernesky, PhD, St Joseph’s Healthcare, 50 Charlton Ave East, Hamilton, ON, Canada L8N 4A6. E-mail: chernesk@mcmaster.ca.

Received for publication December 19, 2013, and accepted March 5, 2014.

© Copyright 2014 American Sexually Transmitted Diseases Association