Clinical Validation of the cobas HPV Test on the cobas 6800 System for the Purpose of Cervical Screening.
This study demonstrates that the clinical sensitivity, specificity, and reproducibility of the novel cobas human papillomavirus (HPV) test on the cobas 6800 system for high-risk HPV types fulfills the criteria for use in population-based cervical screening. The criteria were formulated by an international consortium, using the cobas 4800 HPV test as a validated reference assay. The cobas HPV test detected over 98% of histologically confirmed cervical intraepithelial neoplasia grade 2+ (CIN2+) lesions in women age 30 years or older, with a specificity of 98.9% compared with the reference cobas 4800 test. Both the intra- and interlaboratory agreement for the cobas HPV test were 98%. The clinical performance of the cobas HPV test is comparable to those of longitudinally validated HPV assays and fulfills the criteria for its use in primary cervical screening.
['Saville|Marion|M|', 'Sultana|Farhana|F|', 'Malloy|Michael J|MJ|', 'Velentzis|Louiza S|LS|', 'Caruana|Michael|M|', 'Ip|Ellen L O|ELO|', 'Keung|Marco H T|MHT|', 'Canfell|Karen|K|', 'Brotherton|Julia M L|JML|', 'Hawkes|David|D|']
D000328:Adult D018290:Cervical Intraepithelial Neoplasia D055088:Early Detection of Cancer D005260:Female D006801:Humans D008137:Longitudinal Studies D008875:Middle Aged D025202:Molecular Diagnostic Techniques D027383:Papillomaviridae D030361:Papillomavirus Infections D015203:Reproducibility of Results D012680:Sensitivity and Specificity D002583:Uterine Cervical Neoplasms
HPV cervical cervical screening assay cervical intraepithelial neoplasia performance