Clinical performance of Roche Cobas 4800 HPV Test.
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.
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Miao
M
Cui
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Nicholas
N
Chan
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Momo
M
Liu
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Khanh
K
Thai
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Joanna
J
Malaczynska
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
Ila
I
Singh
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA.
David
D
Zhang
Department of Pathology, Mount Sinai School of Medicine, New York, New York, USA fei.ye@mssm.edu.
Fei
F
Ye
D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity