迪雅科 GenoFlow 人乳头瘤病毒芯片检测与罗氏线性阵列 HPV 基因分型检测的比较
Comparison of the DiagCor GenoFlow Human Papillomavirus Array Test and Roche Linear Array HPV Genotyping Test.
作者信息
Wong Fiona K Y, Ching Johannes C Y, Chow Joseph K F
机构信息
DiagCor Bioscience Inc. Ltd., Hong Kong SAR, China.
出版信息
Open Virol J. 2010 Nov 3;4:169-74. doi: 10.2174/1874357901004010169.
Persistent infection of high-risk (HR) human papillomavirus (HPV) infection has been widely associated with cervical cancer. Monitoring HPV infection is therefore an important step against cervical cancer development. The DiagCor GenoFlow Human Papillomavirus Array Test (GenoFlow) is a novel HPV test based on PCR and "Flow-through" hybridization that can identify 33 HPV subtypes in 3 hours. In the present study, the GenoFlow Test was evaluated by comparing the genotyping results of 100 samples with Roche Linear Array HPV Genotyping Test (LA). The tests showed good agreement in detection of HPV-positive samples (concordance rate=95%, Cohen's Kappa=0.896), with good agreement in detection of HR HPVs (Cohen's Kappa=0.876). The GenoFlow Test showed high sensitivity (95%), high specificity (95%), low false positive rate (3.33%) and low false negative rate (7.50%). In conclusion, the novel GenoFlow Test showed comparable clinical performance to LA test, and offers advantages of reduction in turnaround time and manpower.
高危型（HR）人乳头瘤病毒（HPV）的持续感染与宫颈癌广泛相关。因此，监测HPV感染是预防宫颈癌发生的重要一步。DiagCor GenoFlow人乳头瘤病毒芯片检测（GenoFlow）是一种基于PCR和“液流”杂交的新型HPV检测方法，能够在3小时内鉴定33种HPV亚型。在本研究中，通过将100份样本的基因分型结果与罗氏线性阵列HPV基因分型检测（LA）进行比较，对GenoFlow检测进行了评估。两种检测方法在检测HPV阳性样本方面显示出良好的一致性（符合率=95%，Cohen's Kappa=0.896），在检测高危型HPV方面也具有良好的一致性（Cohen's Kappa=0.876）。GenoFlow检测显示出高灵敏度（95%）、高特异性（95%）、低假阳性率（3.33%）和低假阴性率（7.50%）。总之，新型GenoFlow检测显示出与LA检测相当的临床性能，并且具有缩短周转时间和人力的优势。
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