Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples

Abstract

The performance and acceptability of first-void urine as specimen for the detection of HPV DNA in a Belgian referral population was evaluated using an optimized sample collection and processing protocol. One hundred ten first-void urine and cervical samples were collected from 25- to 64-year-old women who were referred for colposcopy (January–November 2016). Paired samples were analyzed by the Riatol qPCR HPV genotyping assay. Acceptability data were gathered through questionnaires (NCT02714127). A higher high-risk HPV DNA prevalence was observed in first-void urine (n = 76/110) compared to cervical samples (n = 73/110), with HPV31 and HPV16/31 being most prevalent correspondingly. For both any and high-risk HPV DNA, good agreement was observed between paired samples (Cohen’s Kappa of 0.660 (95% CI: 0.486–0.833) and 0.688 (95% CI: 0.542–0.835), respectively). In addition, significant positive correlations in HPV copies (per microliter of DNA extract) between paired samples were observed for HPV16 (rs = 0.670; FDR (false discovery rate)-adjusted p = 0.006), HPV18 (rs = 0.893; FDR-adjusted p = 0.031), HPV31 (rs = 0.527; FDR-adjusted p = 0.031), HPV53 (rs = 0.691; FDR-adjusted p = 0.017), and HPV68 (rs = 0.569; FDR-adjusted p = 0.031). First-void urine sampling using a first-void urine collection device was preferred over a clinician-collected cervical sample. And mostly, first-void urine sampling at home was favored over collection at the clinic or the general practitioner’s office. First-void urine sampling is a highly preferred, non-invasive method that ensures good agreement in HPV DNA (copies) with reference cervical samples. It is particularly interesting as a screening technique to reach non-participants, and its clinical performance should be further evaluated.Electronic supplementary materialThe online version of this article (10.1007/s10096-017-3179-1) contains supplementary material, which is available to authorized users.

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

“…Thus, the lower hrHPV positivity in urine may be due to specimen type differences rather than the assay itself [15]. Our result corresponds to most comparative studies [9-12, 15, 28, 29], but not all [13,14,27].…”

“…In comparison, invalid test rates of urine samples have in other studies been reported to range between 0 and 4% using PCRbased HPV DNA assays [9,10,[12][13][14][15]29]. Whether optimizing the (pre)-analytical processing protocols could lead to better results for the CLART assay warrants further exploration.…”

“…As our study was the only one with an interval between the urine and cervical sample, some of the differences in concordance may be attributed to this factor. Other reasons for the differences are likely explained by variations in sampling procedure (at home vs. clinic), type of preservative media [27], (pre-) analytical processing protocols [13], storage conditions [27], the volume of urine collected [27], and study populations (differences in abnormal cytology prevalence). The concordance between urine and cervical samples for hrHPV detection using COBAS remained robust (κ = 0.61), when including the 58 women who had an invalid test result by CLART only in the analysis (data not shown).…”

“…Several studies have assessed the hrHPV concordance and agreement between urine samples versus cervico-vaginal selfsamples and clinician-collected cervical samples using a great variety of hrHPV DNA assays [9][10][11][12][13][14][15]. However, little attention has been given to the direct comparison of different hrHPV DNA assays within the same study [12,15]; thus no strong conclusions about assay effects can be made.…”

“…Yet, if urine collection is to be implemented in an organized screening program, a home-based setting with mailing of the samples to the laboratory would be desirable. Urine collection at clinics has been reported to be highly acceptable [10,13] and preferable over cervico-vaginal self-sampling and clinician-based screening [16,17]; yet data regarding women's acceptability and preferences towards home-based urine collection are lacking.…”