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J Clin Virol. 2018 Feb - Mar;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.

Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions.

Author information

1
Department of Research, Cancer Registry of Norway, 0379 Oslo, Norway. Electronic address: maarit.leinonen@kreftregisteret.no.
2
Department of Research, Cancer Registry of Norway, 0379 Oslo, Norway.
3
Center for Laboratory Medicine, Østfold Hospital Trust, 1714 Grålum, Norway; Faculty of Chemistry, Biotechnology and Food Science, Norwegian University of Life Sciences, 1432 Ås, Norway.
4
Center for Laboratory Medicine, Østfold Hospital Trust, 1714 Grålum, Norway.
5
Department of Pathology, Oslo University Hospital, 0379 Oslo, Norway.
6
Department of Cervical Cancer Screening, Cancer Registry of Norway, 0379 Oslo, Norway; Department of Gynecologic Cancer, Division of Cancer Medicine, Oslo University Hospital, 0379 Oslo, Norway.
7
Department of Obstetrics and Gynaecology, Østfold Hospital Trust, 1714 Grålum, Norway.
8
Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY 10461, USA.

Abstract

BACKGROUND:

Comparative data on different self-collection methods is limited.

OBJECTIVES:

To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions.

STUDY DESIGN:

Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn®Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas® 4800 HPV Test and Xpert®HPV.

RESULTS:

Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn®Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas® 0.96; Xpert®HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas® 0.92; Xpert®HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn®Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn®Brush easier and more comfortable than FLOQSwabs™.

CONCLUSIONS:

Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02945891.

KEYWORDS:

Acceptability; Device; HPV test; Performance; Self-sampling; Vaginal smear

PMID:
29289814
DOI:
10.1016/j.jcv.2017.12.008
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