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Cobas 4800 HPV detection in the cervical, vaginal and urine samples of women with high-grade CIN before and after treatment
  1. Grazyna A Stanczuk1,
  2. Heather Currie2,
  3. Gwen Baxter1,
  4. Adele Foster3,
  5. Lindsay Gibson3,
  6. Catriona Graham4,
  7. Kate Cuschieri5
  1. 1Department of Research and Development, Dumfries and Galloway Royal Infirmary, Dumfries, UK
  2. 2Department of Obstetrics and Gynaecology, Dumfries and Galloway Royal Infirmary, Dumfries, UK
  3. 3Department of Microbiology, Dumfries and Galloway Royal Infirmary, Dumfries, UK
  4. 4Wellcome Trust Clinical Research Facility, University of Edinburgh, Western General Hospital, Edinburgh, UK
  5. 5Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK
  1. Correspondence to Dr Grazyna A Stanczuk, Department of Research and Development, Dumfries and Galloway Royal Infirmary, Dumfries DG1 4AP, UK; grazyna.stanczuk{at}


Aims To assess the performance of a clinically validated human papillomavirus (HPV) test (the Cobas 4800 HPV test) in urine and self-taken vaginal specimens within a colposcopy population and to assess HPV prevalence before and after treatment across the different biospecimens.

Methods A total of 100 women attending a colposcopy clinic provided three biospecimens (a clinician-taken liquid-based cytology sample (LBC), a self-taken vaginal sample and a urine sample) for HPV testing. HPV prevalence and concordance was compared across the biospecimens and clinical performance relative to the detection of cervical intraepithelial neoplasia (CIN)2+ and CIN3+ was assessed. A total of 39 women retuned at 6 months for a post-treatment follow-up appointment, and HPV concordance in all biospecimens was measured relative to their original HPV status.

Results 65 cases of CIN2+ were detected in the baseline population; sensitivity for CIN2+ was 92% (82 to 97) for the vaginal and the LBC sample and 80.0 (68% to 88%) for the urine sample. In the follow-up (post treatment) population, women were twice as likely to be HPV positive in their urine or vaginal sample compared with the equivalent LBC sample.

Conclusions Vaginal and LBC samples showed very similar performance for the detection of CIN2+ in this population using the Cobas HPV test; further validation of these findings in screening contexts will be of value. Self-taken samples may have less utility in a ‘test of cure’ setting—given the higher prevalence of HPV relative to LBC.

  • HPV

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