Randomised study of HPV prevalence and detection of CIN2+ in vaginal self‐sampling compared to cervical specimens collected by medical personnel

Abstract

We conducted a randomised study to compare vaginal self-sampling with assisted sampling by medical personnel on the cervix for HPV testing in primary screening. The first aim was to determine if the HPV prevalence is independent of sampling location (vagina versus cervix) and the person performing the sampling. The second aim was to evaluate if the two sampling strategies differed in the detection rate of CIN2+. In total, 19,523 women were randomised into two groups, with 9926 invited to perform self-sampling (SS arm) using the Rover VIBA-brush and 9597 offered assisted sampling using the cytobrush (AS arm). All samples were applied to the indicating FTA elute card and analysed for high-risk HPV using the hpVIR real-time PCR assay. The outcome for the first aim was HPV prevalence and for the second aim the number of CIN2+ based on histology. In the SS arm, 52.7% of invited women participated in the study, as compared to 34.2% in the AS arm. All samples contained sufficient amount of nuclear DNA for a valid HPV result, with vaginal samples having a higher DNA amount than cervical samples (p < 4.62 × 10 ). HPV prevalence was 4.6% in the SS arm and 4.1% in the AS arm (p = 5.5 × 10 ), and the distribution of HPV types similar between arms. There was no difference in the prevalence of CIN2+ per 1000 women screened between arms (p = 0.86). The results show that vaginal self-sampling is an equivalent alternative to sampling by medical personnel for HPV typing and identification of CIN2+.

Clinical validation of the HPVIR high-risk HPV test on cervical samples according to the international guidelines for human papillomavirus DNA test requirements for cervical cancer screening

“…HPV testing using vaginal self-sampling on FTA card has been shown to be as reliable as assisted cervical sampling [14, 15]. We have recently shown that repeating the self-sampling and HPV test for women that were HPV positive in the screening sample after 4–6 months, in order to identify women with persistent infections, can results in more than two-fold higher detection rate of CIN2 + -lesions, compared to cytology screening [14, 15]. This method could decrease both incidence and mortality in cervical cancer, as early detection and treatment remains the most effective means of prevention.…”

“…HPVIR is a laboratory developed (LDT), multiplex real-time PCR test, detecting and quantifying HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 [11]. In this application, a cervical or vaginal sample is applied on an indicating FTA elute micro card™ [12–15] and left to dry before storage. The clinical material applied to this card is stable at room temperature and samples stored on FTA cards for 1 year have shown identical HPV typing results as compared to the use of liquid-based cytology (LBC) collection media [16].…”

“…One advantage of using the FTA card is their suitability for self-sampling, which represent an important development of cervical cancer screening. Recently, we have shown that repeated self-sampling on FTA cards is as reliable for HPV testing as assisted sampling by a midwife or gynaecologist [14, 15], and that this strategy can result in detection of more than twice as many women with ≥ CIN2 in histology as compared to screening with cytology [14, 15]. In this study we have validated our method of applying samples on the indicating FTA card and using the HPVIR test according to criteria of Meijer and co-workers [2], using collection of LBC samples and the Cobas ® HPV test as reference test.…”

HPV viral load in self-collected vaginal fluid samples as predictor for presence of cervical intraepithelial neoplasia

“…The data was derived from women between 30 and 60 years of age participating in two randomized intervention studies that were conducted in Uppsala County, Sweden, between 2013 and 2015 [3, 23]. The first randomized study included women between 30 and 49 years of age and had as aim to compare the detection rate of CIN2+ lesions based on histology in women performing repeated self-sampling of vaginal fluid for hrHPV testing with women following the regular screening program based on Pap smear cytology [3].…”

National data analysis and systematic review for human resources for cervical cancer screening in Japan: Who should take Pap smears for cervical cancer screening?

“…Interestingly, recent studies have reported that self-sampling HPV testing is a useful approach to increasing the participation rate [32]. Also, the sensitivity and speci city of self-sampling HPV testing are nearly equal to those of a clinician performing the HPV testing [32][33][34]. Some countries have already introduced self-sampling HPV testing for non-attenders [35,37].…”