Good concordance of HPV detection between cervico-vaginal self-samples and general practitioner-collected samples using the Cobas 4800 HPV DNA test

Abstract

BackgroundStudies comparing self-samples and clinician-collected samples for high-risk human papillomavirus (HPV) detection using clinically validated PCR-based HPV DNA assays are limited. We measured the concordance of HPV detection between home-based self-sampling and general practitioner (GP) sampling using the Cobas 4800 HPV DNA test and studied women’s accept of home-based self-sampling.MethodsPaired GP-collected samples and cervico-vaginal self-samples were obtained from 213 women aged 30–59 years diagnosed with ASC-US within the cervical cancer screening program. After undergoing cervical cytology at their GP, the women collected a self-sample with the Evalyn Brush at home and completed a questionnaire. Both samples were HPV-tested using the Cobas 4800 test. Histology results were available for those who tested HPV positive in GP-collected samples.ResultsWe observed good concordance for HPV detection between self-samples and GP-collected samples (κ: 0.70, 95% CI: 0.58–0.81). No underlying CIN2+ cases were missed by self-sampling. Women evaluated that self-sampling was easy (97.2%, 95% CI: 93.9–98.9%) and comfortable (94.8%, 95% CI: 90.9–97.4%).ConclusionsHome-based self-sampling using the Evalyn Brush and the Cobas 4800 test is an applicable and reliable alternative to GP-sampling.

Urine Collection in Cervical Cancer Screening – Comparison of Two HPV DNA Assays

“…Exclusion criteria were pregnancy and having given birth within the last 3 months. The recruitment procedure has been described in detail in a previous publication [19]. In brief, eligible women were consecutively mailed a consent form and an information letter about the study explaining that they had to contact the investigator for oral information regarding the study and return a signed informed consent if they wanted to participate.…”

“…As per routine, the women had a cervical sample collected with a cervical cytobrush at their GP. After collecting cervical epithelial cells, the cervical brush was rinsed in 10 mL SurePath medium (BD Diagnostics, Burlington, NC) and mailed to the Department of Pathology, Randers Regional Hospital, for routine processing and testing as previously described [19]. The COBAS hrHPV testing was performed as per routine using the sample cell pellet from 1 ml SurePath medium.…”

“…A 6.4 mL volume of the self-sample material was centrifuged at 3000 x RPM for 20 min at room temperature [19]. With the supernatant removed, the cell pellet was placed in 1 mL 25% ethanol-buffered (TRIS) and stored at -80 C until further hrHPV testing [19]. A volume of 6.4 mL was chosen to adjust for material volume used for cytology examination performed on the cervical sample [19].…”

“…Before the day of COBAS hrHPV DNA testing, the cell pellet material from the urine and cervico-vaginal self-samples were thawed overnight at 4˚C. Subsequently, the self-samples (1 mL volume) were vortexed for 15 s before being transferred to empty test tubes for DNA puri cation and hrHPV testing [19]. DNA was puri ed using the COBAS x480, and ampli cation and detection of hrHPV DNA were undertaken using the COBAS z480 analyzer [21].…”

“…COBAS: no betaglobin gene detected, CLART: no human CFTR ampli cation detected, or no spiked CFTR plasmid ampli cation detected) were retested once on diluted samples, and the second result was considered de nitive. Every run included four water samples to measure contamination [19]. The laboratory personnel performed the hrHPV testing without knowledge of the hrHPV status of the cervical samples [19].…”