4.7 Article

Clinical Validation of the cobas HPV Test on the cobas 6800 System for the Purpose of Cervical Screening

期刊

JOURNAL OF CLINICAL MICROBIOLOGY
卷 57, 期 2, 页码 -

出版社

AMER SOC MICROBIOLOGY
DOI: 10.1128/JCM.01239-18

关键词

HPV; assay; cervical; cervical intraepithelial neoplasia; cervical screening; performance

资金

  1. National Health and Medical Research Council [APP1135172]
  2. Roche Molecular Systems

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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 I-IPV 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.

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