Performance of an affordable urine self-sampling method for human papillomavirus detection in Mexican women

Abstract

Introduction Urine self-sampling for human papillomavirus (HPV)-based cervical cancer screening is a non-invasive method that offers several logistical advantages and high acceptability, reducing barriers related to low screening coverage. This study developed and evaluated the performance of a low-cost urine self-sampling method for HPV-testing and explored the acceptability and feasibility of potential implementation of this alternative in routine screening. Methods A series of sequential laboratory assays examined the impact of several pre-analytical conditions for obtaining DNA from urine and subsequent HPV detection. Initially, we assessed the effect of ethylaminediaminetetraacetic acid (EDTA) as a DNA preservative examining several variables including EDTA concentration, specimen storage temperature, time between urine collection and DNA extraction, and first-morning micturition versus convenience sample collection. We further evaluated the agreement of HPV-testing between urine and clinician-collected cervical samples among 95 women. Finally, we explored the costs of self-sampling supplies as well as the acceptability and feasibility of urine self-sampling among women and healthcare workers. Results Our results revealed higher DNA concentrations were obtained when using a 40mM EDTA solution, storing specimens at 25°C and extracting DNA within 72 hrs. of urine collection, regardless of using first-morning micturition or a convenience sampling. We observed good agreement (Kappa = 0.72) between urine and clinician-collected cervical samples for HPV detection. Furthermore, urine self-sampling was an affordable method (USD 1.10), well accepted among cervical cancer screening users, healthcare workers, and decision-makers. Conclusion These results suggest urine self-sampling is feasible and appropriate alternative for HPV-testing in HPV-based screening programs in lower-resource contexts.

Utilizing first void urine for high-risk HPV testing for cervical cancer screening in HIV-positive women in Katete, Zambia

“…Our study confirms that HPV DNA can be detected in first void urine as reported by several studies. However, different results have been reported [ 12 , 13 , 16 , 17 , 23 , 24 ]. In this study, we found substantial agreement between first void urine and clinician-collected cervical samples with prevalence of 34% (95% CI 24%–43.9%) for both samples, and infections with hrHPV types classified as ‘Other hrHPV types’ by the GeneXpert platform being more common.…”

“…A clinically validated and highly sensitive HPV assay (GeneXpert) was used, and urine samples were tested with blinding of cervical results. We used an affordable urine collection container and preservative that is more practical in low-resource settings as reported by Hernandez-Lopez et al [ 23 ]. Most of the previous studies have used specially designed urine collection containers and preservatives that are costly for developing countries [ 32 ].…”

“…Most of the previous studies have used specially designed urine collection containers and preservatives that are costly for developing countries [ 32 ]. However, EDTA solution is inexpensive and has been reported to prevent HPV DNA degradation in urine [ 23 ]. As suggested by Marcus et al [ 16 ], we used 2 mL of first void urine for testing to help improve HPV DNA detection.…”

“…However, increasing the interval between two urinations to at least 2 h could result in improved HPV DNA detection due to increased HPV DNA concentration as a result of an increase in the accumulation of mucus and secretions from the cervix and vagina that are captured in first void urine [ 12 , 15 ]. Optimal conditions for longer storage of EDTA preserved first void urine should be explored to allow for home collection of samples [ 23 ]. Collection containers designed to capture a standardized volume of first void urine, prefilled with a preservative solution can be used to reduce on sampling errors [ 3 ].…”

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

“…Therefore, it supports the further investigation of the implementation of urine collection as cervical cancer screening method. Another strength of this study is the high response rate (97%) and that urine was collected in basic urine collection cups, which are affordable ( Hernandez-Lopez et al, 2021 ). The main limitation of this study is that the majority of the women had a history of attending cervical cancer screening (n = 104, 74%) and that all women had an abnormal cervical cytology prior to study participation.…”