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Comparison of the performance of HPV tests in women with abnormal cytology: results of a study within the NHS cervical screening programme
Author(s) -
Moss S. M.,
Bailey A.,
Cubie H.,
Denton K.,
Sargent A.,
Muir P.,
Vipond I. B.,
Winder R.,
Kitchener H.
Publication year - 2015
Publication title -
cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.512
H-Index - 48
eISSN - 1365-2303
pISSN - 0956-5507
DOI - 10.1111/cyt.12210
Subject(s) - medicine , colposcopy , cervical intraepithelial neoplasia , cytology , triage , squamous intraepithelial lesion , gynecology , cervical screening , obstetrics , human papillomavirus , referral , cervical cancer , pathology , family medicine , cancer , emergency medicine
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.