|Title||Evaluation of commercial HPV assays in the context of post-treatment follow-up: Scottish Test of Cure Study (STOCS-H).|
|Publication Type||Journal Article|
|Year of Publication||2014|
|Authors||Cubie HA, Canham MA, Moore C, Pedraza J, Graham C, Cuschieri K|
|Journal||J Clin Pathol|
|Date Published||2014 Jun|
|Keywords||Cervical Intraepithelial Neoplasia, DNA, Viral, Female, Human Papillomavirus DNA Tests, Humans, Incidence, Observer Variation, Papillomaviridae, Papillomavirus Infections, Predictive Value of Tests, Prevalence, Reagent Kits, Diagnostic, Reproducibility of Results, Risk Factors, Scotland, Time Factors, Treatment Outcome, Uterine Cervical Neoplasms|
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.
|Alternate Journal||J. Clin. Pathol.|