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

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. 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. 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. These results suggest urine self-sampling is feasible and appropriate alternative for HPV-testing in HPV-based screening programs in lower-resource contexts.

Déclaration de conflit d'intérêts

I have read the journal’s policy and the authors of this manuscript have the following competing interests: JS and ELP have received funding through their institutions for research projects from BD Diagnostics Systems, Roche Molecular Systems, and Roche/Ventana Medical Systems outside the submitted work. JC reported receiving grants from Genera Biosystems and Aventis Pharma; personal fees from Merck and Co. and Roche; and grants and personal fees from Qiagen, and participating in the sponsored speakers’ bureau for Hologic, Gen-Probe, and Becton Dickinson Systems outside the submitted work. CW reported receiving research support from Genera Biosystems, personal fees from Becton Dickinson, and supplies and equipment through her institution from Roche Molecular Systems and Roche/Ventana Medical Systems outside the submitted work. No other disclosures were reported.