S M Moss1, A Bailey2, H Cubie3, K Denton4, A Sargent2, P Muir5, I B Vipond5, R Winder6, H Kitchener7. 1. Centre for Cancer Prevention, Queen Mary University of London, London, UK. 2. Public Health Laboratory, Manchester, UK. 3. Scottish HPV Reference Laboratory, Edinburgh, UK. 4. North Bristol NHS Trust, Bristol, UK. 5. Public Health Laboratory, Public Health England, Bristol, UK. 6. NHS Cancer Screening Programmes, Sheffield, UK. 7. Institute of Cancer Sciences, University of Manchester, Manchester Academic Health Centre, UK.
Abstract
OBJECTIVE: The use of testing for human papillomavirus (HPV) is now recognized as an efficient means of triaging women with low-grade cytological abnormalities to either immediate referral to colposcopy or return to routine recall. We aimed to determine the sensitivity and specificity of each of four newer tests for HPV relative to the Qiagen Hybrid Capture 2 (HC2) assay in order to determine whether they could be approved for use in triage in the NHS cervical screening programme. METHODS: We compared the performance of each of four different HPV assays (Abbott M2000, Roche Cobas, Hologic Cervista and Gen-Probe APTIMA) with that of HC2 in order to determine the sensitivity and specificity of each test relative to HC2 for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse, using routine cytology samples reported as borderline (atypical squamous cells) or mild dyskaryosis (low-grade squamous intraepithelial lesion) from six laboratories in England. All women who were found to be HPV positive on any test were referred to colposcopy. RESULTS: Between 2072 and 4217 tests were performed with each assay. All four assays were shown to have a relative sensitivity of no worse than 95% compared with HC2 when a cut-off of 2 relative light units (RLU) was used. All assays had higher relative specificity than HC2 for both borderline and mild cytology referrals (1.06-1.61). CONCLUSIONS: All assays tested met the criteria required. Consequently, all have now been approved for use in HPV triage in the NHS cervical screening programme.
OBJECTIVE: The use of testing for human papillomavirus (HPV) is now recognized as an efficient means of triaging women with low-grade cytological abnormalities to either immediate referral to colposcopy or return to routine recall. We aimed to determine the sensitivity and specificity of each of four newer tests for HPV relative to the Qiagen Hybrid Capture 2 (HC2) assay in order to determine whether they could be approved for use in triage in the NHS cervical screening programme. METHODS: We compared the performance of each of four different HPV assays (Abbott M2000, Roche Cobas, Hologic Cervista and Gen-Probe APTIMA) with that of HC2 in order to determine the sensitivity and specificity of each test relative to HC2 for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse, using routine cytology samples reported as borderline (atypical squamous cells) or mild dyskaryosis (low-grade squamous intraepithelial lesion) from six laboratories in England. All women who were found to be HPV positive on any test were referred to colposcopy. RESULTS: Between 2072 and 4217 tests were performed with each assay. All four assays were shown to have a relative sensitivity of no worse than 95% compared with HC2 when a cut-off of 2 relative light units (RLU) was used. All assays had higher relative specificity than HC2 for both borderline and mild cytology referrals (1.06-1.61). CONCLUSIONS: All assays tested met the criteria required. Consequently, all have now been approved for use in HPV triage in the NHS cervical screening programme.
Authors: Emma J Crosbie; Andrew Bailey; Alex Sargent; Clare Gilham; Julian Peto; Henry C Kitchener Journal: J Clin Microbiol Date: 2015-09-02 Impact factor: 5.948
Authors: Elisabeth M Bik; Sara W Bird; Juan P Bustamante; Luis E Leon; Pamela A Nieto; Kwasi Addae; Víctor Alegría-Mera; Cristian Bravo; Denisse Bravo; Juan P Cardenas; Glenn A Carson; Adam Caughey; Paulo C Covarrubias; José Pérez-Donoso; Graham Gass; Sarah L Gupta; Kira Harman; Donna Marie B Hongo; Juan C Jiménez; Laurens Kraal; Felipe Melis-Arcos; Eduardo H Morales; Amanda Morton; Camila F Navas; Harold Nuñez; Eduardo Olivares; Nicolás Órdenes-Aenishanslins; Francisco J Ossandon; Richard Phan; Raul Pino; Katia Soto-Liebe; Ignacio Varas; Patricia Vera-Wolf; Nathaniel A Walton; Daniel E Almonacid; Audrey D Goddard; Juan A Ugalde; Susan Zneimer; Jessica Richman; Zachary S Apte Journal: PLoS One Date: 2019-05-01 Impact factor: 3.240