罗氏Cobas® 4800人乳头瘤病毒检测法与罗氏Amplicor检测高危型人乳头瘤病毒的比较
Comparison of the Roche Cobas® 4800 HPV assay to Roche Amplicor for detection of high-risk human papillomavirus.
作者信息
Phillips S, Cornall A M, Machalek D A, Garland S M, Bateson D, Garefalakis M, Tabrizi S N
机构信息
Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.
Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Bio 21 Institute, Parkville, 3052, Australia.
出版信息
Eur J Clin Microbiol Infect Dis. 2016 Aug;35(8):1305-7. doi: 10.1007/s10096-016-2665-1. Epub 2016 May 13.
UNLABELLED
Roche Amplicor HPV (AMP) had previously been used for detection of high-risk human papillomavirus (HR-HPV) in epidemiological and clinical studies. As this assay is no longer available, we compared its performance using PreservCyt samples from women aged of 18-24 years attending for routine cervical cytology screening to Roche Cobas® 4800 (Cobas) to determine if subsequent studies could continue using the Cobas assay. Overall 507 samples were tested on Cobas and compared to previous AMP results, with discrepant samples tested on Roche Linear Array.
RESULTS
Overall, agreement between the Cobas and AMP for the presence of HR HPV types was very high (κ = 0.81) (95 % CI: 0.76 - 0.87) with percentage agreement of 91.57 %. Cobas is comparable to AMP for the detection of HR-HPV types in a community recruited cohort of healthy women.
未标注
罗氏Amplicor人乳头瘤病毒（AMP）检测法先前已用于流行病学和临床研究中的高危型人乳头瘤病毒（HR-HPV）检测。由于该检测法已不再可用，我们将18至24岁接受常规宫颈细胞学筛查的女性的PreservCyt样本使用罗氏Cobas® 4800（Cobas）检测法进行检测，并与AMP检测法的性能进行比较，以确定后续研究是否可以继续使用Cobas检测法。总共对507份样本进行了Cobas检测，并与之前的AMP结果进行比较，对结果不一致的样本使用罗氏线性阵列进行检测。
结果
总体而言，Cobas和AMP检测法在HR HPV类型存在方面的一致性非常高（κ = 0.81）（95%置信区间：0.76 - 0.87），一致性百分比为91.57%。在社区招募的健康女性队列中，Cobas在检测HR-HPV类型方面与AMP相当。
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