Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study

Abstract

ObjectivesTo increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS).DesignCross-sectional study.SettingColposcopy clinic.ParticipantsWomen (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding.InterventionAll women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination.Primary outcomeAbsolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS.Secondary outcomeThe acceptability by women of self-sampling.ResultsBoth the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI).The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar’s test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar’s test >0.05).The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample.ConclusionSelf-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

“…A disadvantage of this study however is that no paired cervical specimen was available to report relative clinical accuracy estimates compared to clinician-collected samples. In their cross-sectional study, Ørnskov (2021) demonstrated both noninferior clinical sensitivity (CIN2+; CIN3+) and specificity (<CIN2) of hrHPV testing in urine collected in a simple urine cup compared to clinician-collected cervical samples [38]. This clinical validation is promising and first to demonstrate both non-inferior clinical sensitivity and specificity for urinary hrHPV testing compared to cervical samples collected by a physician.…”

“…The presented FV urine method is also complementary to high-throughput, automated Abbott RealTime High Risk HPV testing without the need for additional laborious sample handlings steps such as preservative addition or centrifugation reported by others [13,37,38]. Colli-Pee collected, UCM preserved FV urine allows for sample handling following the same procedure applied for manufacturer validated cervical samples collected by a clinician.…”

“…Importantly, both studies used FV urine, which significantly impacts accuracy of hrHPV testing in urine [15,18,19]. Just recently, Cadman (2021) [22] and Ørnskov (2021) [38] reported on clinical accuracy of urinary hrHPV testing using the BD Onclarity and Roche Cobas 4800 HPV assay, respectively. The Predictors 5.1 study demonstrated similar sensitivity of hrHPV testing in Colli-Pee collected (and UCM preserved) FV urine to detect CIN2+ compared to the wet digene Female Swab (Qiagen GmbH) used as comparator, yet observed lower specificity for <CIN2 [22].…”

Cervical Cancer Screening Postpandemic: Self-Sampling Opportunities to Accelerate the Elimination of Cervical Cancer

“… 119 Ørnskov et al found absolute sensitivity for CIN2 + of urine and vaginal self-samples was comparable to cervical clinician-collected samples (93% for urine samples and 96% for self-collected samples). 122 Furthermore, a majority of studies of HPV testing on urine samples have noted lower hrHPV positivity than corresponding vaginal samples. 118 , 120 , 123–125 …”

Experiences and preferences towards collecting a urine and cervicovaginal self-sample among women attending a colposcopy clinic

“…This may consequently lead to an increase in attendance and effectiveness of cervical cancer screening ( Tranberg et al, 2020 ). Especially urine collection looks promising as it has been reported as the most preferred sampling method for cervical cancer screening in several studies ( Leeman et al, 2017 , Ørnskov et al, 2021 , Rohner et al, 2020 , Sargent et al, 2019 , Tranberg et al, 2020 ). However, urine collection methods differ in these studies and few studies have compared the collection of complete urine void without special devices to cervicovaginal self-sampling in a home-based setting ( Leeman et al, 2017 , Ørnskov et al, 2021 , Rohner et al, 2020 , Sargent et al, 2019 , Tranberg et al, 2020 ).…”