Clinical performance of Roche Cobas 4800 HPV Test

Miao Cui; Nicholas Chan; Momo Liu; Khanh Thai; Joanna Malaczynska; Ila Singh; David Zhang; Fei Ye

doi:10.1128/JCM.00883-14

Clinical performance of Roche Cobas 4800 HPV Test

J Clin Microbiol. 2014 Jun;52(6):2210-1. doi: 10.1128/JCM.00883-14. Epub 2014 Apr 9.

Authors

Miao Cui¹, Nicholas Chan¹, Momo Liu¹, Khanh Thai¹, Joanna Malaczynska¹, Ila Singh¹, David Zhang¹, Fei Ye²

Affiliations

¹ Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
² Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA [email protected].

Abstract

Evaluation of the Cobas 4800 test demonstrated that Cobas had a low rate of cross-reactivity with low-risk human papillomavirus (lrHPV), a 3.74% disconcordance rate between prealiquots and postaliquots, and failure rates of 4.57% and 1.16%, respectively, after vortexing and swirling. This study demonstrated that the Cobas test has good sensitivity, accuracy, and reproducibility for detecting 14 high-risk HPV (hrHPV) genotypes.

Publication types

Evaluation Study

MeSH terms

Female
Humans
Molecular Diagnostic Techniques / methods*
Papillomaviridae / isolation & purification*
Papillomavirus Infections / diagnosis*
Reproducibility of Results
Sensitivity and Specificity