Kate Cuschieri1, Heather Cubie2, Catriona Graham3, Jennifer Rowan4, Alison Hardie5, Andrew Horne6, Camille Busby Earle3, Andrew Bailey7, Emma J Crosbie8, Henry Kitchener8. 1. Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom. Electronic address: Kate.Cuschieri@luht.scot.nhs.uk. 2. HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, United Kingdom. 3. Epidemiology and Statistics Core, Wellcome Trust Clinical Research Facility, Edinburgh, United Kingdom. 4. Simpsons Centre for Reproductive Health, Royal Infirmary of Edinburgh, United Kingdom. 5. Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, United Kingdom. 6. MRC Centre for Reproductive Health, University of Edinburgh, United Kingdom. 7. Manchester Medical Microbiology Partnership, Manchester Royal Infirmary, United Kingdom. 8. Institute of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.
Abstract
BACKGROUND: As HPV testing is used increasingly for cervical disease management, there is a demand to optimise the performance of HPV tests, particularly with respect to specificity. OBJECTIVES: To compare the clinical performance of an HPV DNA and a RNA based test in women with cytological abnormalities. The influence of age and assay cut off on test performance was also assessed. STUDY DESIGN: A prospective comparison of the Hybrid Capture 2 test (HC2) and the Aptima HPV assay (AHPV) was performed within a colposcopy setting. Clinical sensitivity and specificity were determined for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse. RESULTS: Both assays were >90% sensitive for the detection of CIN2+. AHPV was slightly more specific than HC2 [49.9% (46.8-53.1) vs 45.9% (42.8, 49.1), p<0.0001]. Raising HC2 cut off to 2 RLU did not improve specificity. A cut-off of 10 RLU increased specificity by approximately 10% - although this led to a reduction in sensitivity of 6.3% which equated to 24 missed cases of CIN2+. Both assays were more specific in women over 30 years of age, compared to women under 30 (p<0.001). CONCLUSION: Although AHPV was more specific than HC2 in the total cohort (p<0.001), we found this difference to be smaller than other studies. This could be attributed to different indications for colposcopic referral across different settings. This study also confirms the relatively poor specificity of commercial HPV assays in women under 30.
BACKGROUND: As HPV testing is used increasingly for cervical disease management, there is a demand to optimise the performance of HPV tests, particularly with respect to specificity. OBJECTIVES: To compare the clinical performance of an HPV DNA and a RNA based test in women with cytological abnormalities. The influence of age and assay cut off on test performance was also assessed. STUDY DESIGN: A prospective comparison of the Hybrid Capture 2 test (HC2) and the Aptima HPV assay (AHPV) was performed within a colposcopy setting. Clinical sensitivity and specificity were determined for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse. RESULTS: Both assays were >90% sensitive for the detection of CIN2+. AHPV was slightly more specific than HC2 [49.9% (46.8-53.1) vs 45.9% (42.8, 49.1), p<0.0001]. Raising HC2 cut off to 2 RLU did not improve specificity. A cut-off of 10 RLU increased specificity by approximately 10% - although this led to a reduction in sensitivity of 6.3% which equated to 24 missed cases of CIN2+. Both assays were more specific in women over 30 years of age, compared to women under 30 (p<0.001). CONCLUSION: Although AHPV was more specific than HC2 in the total cohort (p<0.001), we found this difference to be smaller than other studies. This could be attributed to different indications for colposcopic referral across different settings. This study also confirms the relatively poor specificity of commercial HPV assays in women under 30.
Authors: Paolo Giorgi Rossi; Simonetta Bisanzi; Elena Allia; Alessandra Mongia; Francesca Carozzi; Anna Gillio-Tos; Laura De Marco; Guglielmo Ronco; Daniela Gustinucci; Annarosa Del Mistro; Helena Frayle; Anna Iossa; Giulia Fantacci; Giampaolo Pompeo; Elena Cesarini; Simonetta Bulletti; Basilio Passamonti; Martina Rizzi; Maria Gabriella Penon; Alessandra Barca; Maria Benevolo Journal: J Clin Microbiol Date: 2017-01-18 Impact factor: 5.948
Authors: Ana Cristina L Macedo; João Carlos N Gonçalves; Daniela Vicente Bavaresco; Antonio José Grande; Napoleão Chiaramonte Silva; Maria Inês Rosa Journal: J Oncol Date: 2019-06-11 Impact factor: 4.375