RealTime 高危 HPV

CE 标志

供体外诊断使用

Abbott RealTime 高危 HPV 可检测 14 种高危 HPV 基因型,并可同时识别 HPV 16 和 HPV 18。 

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描述
 

Abbott RealTime 高危 (HR) HPV 测定是一种定性的体外聚合酶链式反应 (PCR) 测定,采用均相靶标扩增和检测技术从采集于液体细胞培养基中的宫颈细胞中检测高危人乳头瘤病毒(HPV)DNA。Abbott RealTime HR HPV 测定旨在检测 14 种高危 HPV 基因型:16、18、31、33、35、39、45、51、52、56、58、59、66、68,并且对基因型 16、18 进行部分分型从而将其与其他 12 种高危基因型区分开来。

  • 检测单一和混合感染
  • 针对低、中、高通量实验室的解决方案,每次运行多达 96 个测试
  • 使用 m2000 系统系列实现自动化

Abbott RealTime 高危 HPV 测定专门设计用于在采集于患有宫颈癌前病变 (≥ CIN2) 和宫颈癌女性的宫颈样本中检测高危 HPV 基因型,从而在宫颈癌筛查中提供具有临床意义的结果。

HPV 16 和 HPV 18 的风险分级图表

根据国际共识指南得到了临床验证

RealTime HPV 临床验证

 
设计
 

测定设计
Abbott RealTime 高危 HPV 测定设计

 
规格
 
 
 
Abbott RealTime 高危 hpv
仪器 提取:m2000sp、m24;扩增和检测:m2000rt
试剂盒配置 4 x 24 次检测/试剂盒
技术 多重实时 PCR
测定性能 在参照人群中的临床灵敏度和特异性:高危 HPV 检测
临床灵敏度:97.5%**;临床特异性:99.4%**
HPV 高危检测 16、18、31、33、35、39、45、51、52、56、58、59、66、68
HPV 基因型分型 HPV 16、HPV 18
样品类型 PreservCyt 溶液 (Hologic, Inc.)
SurePath 防腐液 (TriPath Imaging)
Abbott Cervi-Collect 标本采集试剂盒
输入容量 400 ul
内部对照品 以一个内源性人 &bgr; 珠蛋白序列作为细胞适用性、样品提取和扩增效率的样品有效性对照品接受检测。
外部对照品 阴性对照品;阳性对照品
报告结果

定性检测 14 种高危 HPV 类型、对 HPV 16 和/或 HPV 18 进行分型、鉴别单一和混合感染

** 包装说明书

订购信息

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