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Evaluation of commercial HPV assays in the context of post-treatment follow-up: Scottish Test of Cure Study (STOCS-H)
  1. H A Cubie1,
  2. M Canham1,
  3. C Moore2,
  4. J Pedraza1,
  5. C Graham3,
  6. K Cuschieri2
  1. 1HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK
  2. 2Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK
  3. 3Wellcome Trust Clinical Research Facility, University of Edinburgh, Western General Hospital, Edinburgh, UK
  1. Correspondence to Professor Heather A Cubie, HPV Research Group, MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, 47 Little France Cres, Edinburgh EH16 4TJ, UK; Heather.Cubie{at}ed.ac.uk

Abstract

Aims Human papillomavirus (HPV) testing is more sensitive than cytology for detection of residual/recurrent cervical disease after lesion treatment. Several HPV test comparison studies have been performed within triage and screening populations, but data on their comparative performance in a test of cure context is lacking. This study aims to address this gap.

Methods We compared the technical and clinical performance of Abbott RealTime High risk (HR)-HPV, Genprobe Aptima PV, Hologic Cervista HPV-HR, Qiagen Hybrid Capture 2 and Roche cobas HPV in the Early Implementation phase of a ‘test of cure’ service within the Scottish Cervical Screening Programme.

Results Valid results with all five HPV Tests from 1020 first samples taken ∼6 months post-treatment showed HPV positivity ranging from 17.84% to 26.96%. There was perfect agreement in 74%, and greatest variation between assays was observed in cytologically negative samples. Clinical performance was judged on cumulative incidence of cervical intraepithelial neoplasia 2+ (CIN2+) during follow-up (mean: 13.2 months). There were 23 cases of CIN2+ of which 14 were CIN3+. All assays, including cytology, were 100% sensitive for detection of CIN3+. Of the nine cases of residual CIN2, three assays detected all, one assay missed one and one assay missed two cases. Specificity ranged from 75% to 84% according to assay.

Conclusions All assays were sensitive for detection of CIN2+ at 6 months post-treatment. The range of positivity equated to a 50% increase between assays with the lowest and highest positivity rates. The relevance of HPV positivity in the absence of cytological abnormalities requires longer follow-up to determine whether additional tools for risk stratification are required.

  • HPV; CIN
  • post-treatment follow-up
  • assay performance;

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