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

• Published in: Microbiology spectrum 2024-10, Vol.12 (10), p.e0149324
• Main Authors: Mehta, Nikita, Keung, Marco Ho Ting, Pineda, Eunice, Lynn, Elliott, Fetene, Dagnachew, Lee, Alvin, Hougardy, Nicolas, Heinrichs, Amelie, Chan, Hiu Tat Mark, Arbyn, Marc, Saville, Marion, Hawkes, David
• Format: Article
• Language: English
• Subjects: Adult; Aged; cervical intraepithelial neoplasia; cervical screening; Cervix Uteri - virology; Clinical Microbiology; clinical validation; diagnostic; Early Detection of Cancer - methods; Female; Genotype; HPV; Human papillomavirus 16 - genetics; Human papillomavirus 16 - isolation & purification; Human papillomavirus 18 - genetics; Human papillomavirus 18 - isolation & purification; Humans; Mass Screening - methods; Middle Aged; Papillomaviridae - classification; Papillomaviridae - genetics; Papillomaviridae - isolation & purification; Papillomavirus Infections - diagnosis; Papillomavirus Infections - virology; Reproducibility of Results; Research Article; Sensitivity and Specificity; Uterine Cervical Dysplasia - diagnosis; Uterine Cervical Dysplasia - virology; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - virology
• ISSN: 2165-0497; 2165-0497
• DOI: 10.1128/spectrum.01493-24

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.