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

被引:1
|
作者
Mehta, Nikita [1 ]
Keung, Marco Ho Ting [1 ]
Pineda, Eunice [1 ]
Lynn, Elliott [1 ]
Fetene, Dagnachew [1 ]
Lee, Alvin [1 ]
Hougardy, Nicolas [2 ]
Heinrichs, Amelie [2 ]
Chan, Hiu Tat Mark [1 ,3 ]
Arbyn, Marc [4 ]
Saville, Marion [1 ,5 ]
Hawkes, David [1 ,6 ,7 ]
机构
[1] Australian Ctr Prevent Cerv Canc, Carlton, Vic, Australia
[2] Vivalia Hosp, Mol Lab, Arlon, Belgium
[3] La Trobe Univ, Dept Physiol Anat & Microbiol, Bundoora, Vic, Australia
[4] Belgian Canc Ctr, Unit Canc Epidemiol, Brussels, Belgium
[5] Univ Malaya, Dept Obstet & Gynaecol, Kuala Lumpur, Malaysia
[6] Univ Melbourne, Dept Biochem & Pharmacol, Melbourne, Vic, Australia
[7] Univ Malaya, Dept Pathol, Kuala Lumpur, Malaysia
来源
MICROBIOLOGY SPECTRUM | 2024年 / 12卷 / 10期
关键词
HPV; clinical validation; diagnostic; cervical screening; cervical intraepithelial neoplasia; DNA TEST REQUIREMENTS; GUIDELINES;
D O I
10.1128/spectrum.01493-24
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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.IMPORTANCEThis 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. 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.
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页数:8
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