Clinical validation of the Roche cobas HPV test on the Roche cobas 5800 system for the purpose of cervical screening

Author:

Mehta Nikita1,Keung Marco Ho Ting1,Pineda Eunice1,Lynn Elliott1,Fetene Dagnachew1,Lee Alvin1,Hougardy Nicolas2,Heinrichs Amelie2,Chan Hiu Tat Mark13,Arbyn Marc4ORCID,Saville Marion15ORCID,Hawkes David167ORCID

Affiliation:

1. Australian Centre for the Prevention of Cervical Cancer, Carlton, Victoria, Australia

2. Molecular Laboratory, Vivalia Hospital, Arlon, Belgium

3. Department of Physiology, Anatomy and Microbiology, LaTrobe University, Bundoora, Victoria, Australia

4. Belgian Cancer Centre/Unit of Cancer Epidemiology, Sciensano, Brussels, Belgium

5. Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia

6. Department of Biochemistry and Pharmacology, The University of Melbourne, Victoria, Australia

7. Department of Pathology, University of Malaya, Kuala Lumpur, Malaysia

Abstract

ABSTRACT This study assessed the relative clinical sensitivity and specificity, as well as reproducibility, for high-risk HPV types of the Roche cobas HPV test when processed using the Roche cobas 5800 system. The results from this study demonstrate that the cobas HPV test using the cobas 5800 system fulfils the Meijer criteria for use in population-based cervical screening. This clinical validation study also examines the clinical sensitivity and specificity based on partial genotyping, with separate detection of HPV16 and HPV18, compared with the Roche cobas 4800 HPV test, a second-generation standard comparator assay. The cobas HPV test has a relative clinical sensitivity of 1.000, when compared with the cobas 4800 HPV test to detect histologically confirmed CIN2+ lesions in woman aged 30 years or older, with a relative clinical specificity of 0.995. The general intra- and inter-laboratory agreement for the cobas HPV test on the cobas 5800 system for finding a HPV positive result were 99.1% and 99.6%, respectively. IMPORTANCE This study demonstrates, for the first time, the clinical performance of the Roche cobas HPV test when processed using the new cobas 5800 system [cobas (5800)]. This study shows that the cobas (5800) demonstrates relative clinical sensitivity and specificity, when compared with a standard comparator HPV test, which meets the international HPV test validation requirements. Intra- and inter-laboratory reproducibility also fulfills these criteria. The current study demonstrates that the cobas (5800) can be used for primary HPV-based cervical screening on cervical specimens.

Funder

Roche Holding | Roche Diagnostics

Publisher

American Society for Microbiology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3