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. 2019 Jan 30;57(2):e01239-18.
doi: 10.1128/JCM.01239-18. Print 2019 Feb.

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

Marion Saville  1   2   3   4 , Farhana Sultana  1   5 , Michael J Malloy  1   5 , Louiza S Velentzis  5   6 , Michael Caruana  6 , Ellen L O Ip  1   2 , Marco H T Keung  1   2 , Karen Canfell  6   7 , Julia M L Brotherton  1   4   5 , David Hawkes  8   2   9
Affiliations

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

Marion Saville et al. J Clin Microbiol. .

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.

Keywords: HPV; assay; cervical; cervical intraepithelial neoplasia; cervical screening; performance.

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