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

PLoS One. 2021 Jul 21;16(7):e0254946. doi: 10.1371/journal.pone.0254946. eCollection 2021.


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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alphapapillomavirus* / genetics
  • Alphapapillomavirus* / metabolism
  • Cervix Uteri / metabolism
  • Cervix Uteri / virology
  • DNA, Viral* / genetics
  • DNA, Viral* / urine
  • Early Detection of Cancer*
  • Female
  • Humans
  • Middle Aged
  • Papillomavirus Infections* / diagnosis
  • Papillomavirus Infections* / genetics
  • Papillomavirus Infections* / urine
  • Papillomavirus Infections* / virology
  • Urine Specimen Collection*
  • Uterine Cervical Neoplasms* / diagnosis
  • Uterine Cervical Neoplasms* / urine
  • Uterine Cervical Neoplasms* / virology


  • DNA, Viral

Grant support

This study was supported by the National Council of Science and Technology of Mexico (CONACyT), CONACYT-FOINS 2016, FON.INST./261/2016/2016 grant number 274836, received by JS. Additional support was provided by BD Diagnostics Systems;, which was limited to HPV testing supplies. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The funders had no role in study design, data collection and analysis, decision to publish, or preparation and revision of the manuscript.