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

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

doi:10.1128/JCM.01239-18

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

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

Authors

Marion Saville^{1

2

3

4}, Farhana Sultana^{1

5}, Michael J Malloy^{1

5}, Louiza S Velentzis^{5

6}, Michael Caruana⁶, 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

¹ VCS Foundation, Carlton South, Victoria, Australia.
² VCS Pathology, Carlton South, Victoria, Australia.
³ Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia.
⁴ Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia.
⁵ Melbourne School of Population and Global Health, Level 4, The University of Melbourne, Melbourne, Victoria, Australia.
⁶ Cancer Research Division, Cancer Council NSW, Woolloomooloo, NSW, Australia.
⁷ School of Public Health, Sydney Medical School University of Sydney, NSW, Australia.
⁸ VCS Foundation, Carlton South, Victoria, Australia [email protected].
⁹ Department of Pharmacology and Therapeutics, The University of Melbourne, Melbourne, Victoria, Australia.

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.

Publication types

Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Early Detection of Cancer / methods*
Female
Humans
Longitudinal Studies
Middle Aged
Molecular Diagnostic Techniques / methods*
Papillomaviridae / classification*
Papillomaviridae / genetics
Papillomaviridae / isolation & purification*
Papillomavirus Infections / diagnosis*
Papillomavirus Infections / virology
Reproducibility of Results
Sensitivity and Specificity
Uterine Cervical Dysplasia / diagnosis*
Uterine Cervical Neoplasms / diagnosis*