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

Marion Saville,Ellen L O Ip,Michael Caruana,Louiza S Velentzis,David Hawkes,Marco H T Keung,Farhana Sultana,Julia M L Brotherton,Michael J Malloy,Karen Canfell,Melissa B Miller

doi:10.1128/jcm.01239-18

Marion Saville, Ellen L O Ip + Show 9 more

Open Access

https://doi.org/10.1128/jcm.01239-18

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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.

Highlights

Melbourne School of Population and Global Health, Level 4, The University of Melbourne, Melbourne, Victoria, Australia f
We identified a set of 60 cervical screening samples from women who subsequently had histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2), adenocarcinoma in situ (AIS), or worse within 6 months of subsequent follow-up
A CIN2 lesion, which tested negative on the novel cobas human papillomavirus (HPV) test was positive for non-HPV16/18 HPV on the cobas 4800 HPV test (Table 2)

Summary

Introduction

Melbourne School of Population and Global Health, Level 4, The University of Melbourne, Melbourne, Victoria, Australia f. 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. Roche cobas 4800 HPV test as the reference assay, as its sensitivity, specificity, and reproducibility have been demonstrated to be equivalent and statistically noninferior to Hybrid Capture 2 in cross-sectional comparisons [2, 5].

Results

Conclusion