Evaluation of a new APTIMA specimen collection and transportation kit for high-risk human papillomavirus E6/E7 messenger RNA in cervical and vaginal samples.
BACKGROUND
An APTIMA specimen collection and transportation (SCT) kit was developed by Hologic/Gen-Probe.


OBJECTIVE
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.


METHODS
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.
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.
Max
M
Chernesky
Dan
D
Jang
Jodi
J
Gilchrist
Laurie
L
Elit
Alice
A
Lytwyn
Marek
M
Smieja
Janel
J
Dockter
Damon
D
Getman
Jennifer
J
Reid
Craig
C
Hill
D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D003127:Colposcopy; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000235:genetics / Q000473:pathology*; D012333:RNA, Messenger / Q000032:analysis*; D012367:RNA, Viral / Q000032:analysis; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012648:Self Care; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000235:genetics / Q000473:pathology*; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000235:genetics / Q000473:pathology*
D012333:RNA, Messenger; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic