. 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 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 dhawkes@vcs.org.au.
⁹ Department of Pharmacology and Therapeutics, The University of Melbourne, Melbourne, Victoria, Australia.

PMID: 30463896
PMCID: PMC6355513
DOI: 10.1128/JCM.01239-18

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. 2019.

. 2019 Jan 30;57(2):e01239-18.

doi: 10.1128/JCM.01239-18. Print 2019 Feb.

Authors

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 dhawkes@vcs.org.au.
⁹ Department of Pharmacology and Therapeutics, The University of Melbourne, Melbourne, Victoria, Australia.

PMID: 30463896
PMCID: PMC6355513
DOI: 10.1128/JCM.01239-18

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

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

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