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Title: Clinical validation of the cobas HPV test on the cobas 6800 system for the purpose of cervical screening
Authors: Saville M; Sultana F; Malloy MJ; Velentzis L; Caruana M; Ip ELO; Keung MHT; Canfell K; Brotherton JML; Hawkes D
Categories: Cancer Type - Cervical Cancer
Year: 2019
Journal Title: Journal of Clinical Microbiology
Volume: 57
Issue: 2
Abstract: 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.
Division: Cancer Research Division
Funding Body: K.C., M.S., and J.M.L.B. are chief investigators on the National Health and Medical Research Council funded Centre for Research Excellence in Cervical Cancer Control (APP1135172), which provides partial salary support to F.S. and D.H. M.S., K.C., J.M.L.B., and D.H. are investigators on the Compass Trial for which VCS Pathology has received funding from Roche Molecular Systems.
DOI: 10.1128/JCM.01239-18
Appears in Collections:Research Articles

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