Concordance between urine and self-collected vaginal samples for high-risk HPV detection in cervical cancer screening


  • Sreeya Bose Department of Gynecology Oncology, Chittaranjan National Cancer Institute, Kolkata, West Bengal, India
  • Partha Basu Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France
  • Sankar Sengupta Medical Superitendent, Chittaranjan National Cancer Institute, Kolkata, West Bengal, India
  • Ranajit Mandal Department of Gynecology Oncology, Chittaranjan National Cancer Institute, Kolkata, West Bengal, India



Human papilloma virus, Cervical cancer, Urine sampling, Cobas 4800, High risk HPV detection, CIN 2 detection, Vaginal sampling


Background: A system comprising of screening for pre-cancerous lesions succeeded by therapeutic interventions can greatly reduce the incidence of cervical cancer. High risk HPV detection in urine has proven itself as a potential primary screening tool. However, only a few studies have showed it’s concordance with matched self-collected vaginal samples while screening for high risk HPV infection in the community. Objective of the study was to determine the concordance between first void urine sample and self-collected vaginal sample for high risk HPV detection using Cobas 4800. The sensitivity and positive predictive value of screening by urine HPV testing for CIN 2+ detection would also be done along with its acceptability and cost analysis in community screening.

Methods: This study will include women between 30-60 years with intact cervix and no precancerous lesions. Self-sampling will be provided by participants in the form of urine and vaginal swab collection by the Collipee device and vaginal swab stick respectively. This will be followed by high risk HPV testing using Cobas 4800 technology. The participants will also be asked to fill up a questionnaire about the acceptability of urine sampling for cancer screening.

Conclusions: Screening tools can perhaps be diversified in order to suit the needs of low and middle income countries. Research and development of cervical cancer screening tools could hence bring to light feasible alternatives that could further improve compliance of non-attenders.

Trial registration: The trial is registered with clinical trials registry (CTRI/2023/01/049322).


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