Comparison of human papillomavirus testing strategies for triage of women referred with low-grade cytological abnormalities |
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| Authors: | David Mesher Anne Szarewski Louise Cadman Janet Austin Lesley Ashdown-Barr Linda Ho George Terry Martin Young Mark Stoler Christine Bergeron Julie McCarthy Corrina Wright Stuart Liddle WP Soutter Deirdre Lyons Jack Cuzick |
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| Institution: | 1. Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, Charterhouse Square, London EC1M 6BQ, UK;2. Cytopathology Department, Royal Free Hospital, London NW3, UK;3. Department of Pathology, University of Virginia Health System, Virginia 22908, USA;4. Laboratoire Pasteur-Cerba, 95066 Cergy Pontoise Cedex 9, France;5. Cytopathology Department, St. Mary’s Hospital, Praed Street, London W2 1PG, UK;6. The Doctors Laboratory, 60 Whitfield Street, London W1T 4EU, UK;7. Department of Gynaecology, Hammersmith and Queen Charlotte’s & Chelsea Hospitals, Du Cane Rd., London W12 0HS, UK;8. Department of Gynaecology, St. Mary’s Hospital, Praed Street, London W2 1PG, UK |
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| Abstract: | AimTo compare triage strategies using different human papillomavirus (HPV) consensus and genotyping tests and a p16INK4a test.Methods1228 women referred with a borderline or single mildly dyskaryotic smear. Samples were taken at colposcopy using PreservCyt. Tests included Hybrid Capture 2, Abbott RealTime PCR, BD HPV, Cobas 4800, PreTect HPV-Proofer, APTIMA and p16INK4a. Results were based on the worst histology within 9 months.Results97/1228 (7.9%) women had CIN3+ (203/1228 (17%) CIN2+). HPV testing alone using Hybrid Capture 2, Abbott RealTime PCR, BD HPV, Cobas 4800 or APTIMA had a sensitivity for CIN3+ ranging from 99.0% to 100.0% and specificity for <CIN2 from 23.3% to 34.7%. p16INK4a had a sensitivity of 86.8% and specificity of 50.7%. PreTect HPV-Proofer had a sensitivity of 85.1% and specificity of 73.2%. Testing for HPV type 16 only had sensitivities ranging from 66.0% to 75.5% and specificities from 81.3% to 87.6%. Dual testing with HPV type 16 combined with p16INK4a gave a high sensitivity for CIN3+ (78.7% to 98.0%) and specificity for <CIN2 of 58.6% to 81.5%.ConclusionsTriage with sensitive HPV testing assays can substantially reduce the number of unnecessary referrals in women with low grade cytology with virtually no loss of sensitivity. Even greater gains can be made if p16 and type 16 are used, but some cases of CIN2 will be missed. In both cases short term surveillance will be needed. |
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