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artus HBV PCR Kits CE

应用real-time PCR定量检测乙型肝炎病毒DNA

Products

artus HBV PCR Kits CE 旨在用于欧洲体外诊断用途。
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artus HBV RG PCR Kit (96) CE

Cat. No. / ID:   4506265

For 96 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
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artus HBV QS-RGQ Kit (24) CE

Cat. No. / ID:   4506363

For 24 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
R$5,650.00
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artus HBV QS-RGQ Kit (72) CE

Cat. No. / ID:   4506366

For 72 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
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artus HBV RG PCR Kit (24) CE

Cat. No. / ID:   4506263

For 24 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)

特点

  • 整个工作流程符合体外诊断CE认证的要求(QIAsymphony RGQ)
  • 使用内参,具有高度可靠性
  • 检测高灵敏度,可达10.2 IU/ml(QS-RGQ试剂盒)
  • 在从25.6至421,000,000 IU/ml的范围内,检测结果均符合线性规律(QS-RGQ试剂盒)
  • 使用提供的5个标准品进行精确的定量分析

产品详情

artus HBV PCR Kits为即用型分子检测试剂盒,适用于real-time PCR检测。该试剂盒包含体外诊断中对乙型肝炎病毒DNA,包括A到H基因型,进行可靠定量检测的所有所需试剂,并已经过优化。artus HBV LC、RG和TM PCR Kits使用手动样本制备和反应体系构建技术。artus HBV QS-RGQ Kit则可用于QIAsymphony RGQ,从样本制备到病原体检测的整个工作流程都为自动完成,不适用于手动反应体系构建。

绩效

为确保高灵敏度,artus HBV Kits已经过优化,可检测到低拷贝数的乙型肝炎病毒DNA。artus HBV QS-RGQ Kit在QIAsymphony RGQ上使用的检测阈限为10.2 IU/ml(参见" Highly sensitive detection of HBV DNA")。(1 IU/ml相当于在Rotor-Gene Q实时荧光定量PCR分析仪上检测到8.21拷贝/毫升的乙型肝炎病毒DNA。转化因子为平均值。)

为确保高度特异性,已使用多种乙型肝炎病毒,包括A–H基因型和相关病原体对artus HBV Kits进行了验证。

artus HBV RG PCR Kit和artus HBV QS-RGQ Kit的性能特征
试剂盒  artus HBV RG PCR Kit artus HBV QS-RGQ Kit
经过验证的适用样本类型  EDTA血浆 EDTA血浆
检测阈限  3.8 IU/ml 10.2 IU/ml
线性范围  1.1至 >4 x 109 IU/ml  31.6至 >2 x 107 IU/ml
特异性 基因型为A–H的乙型肝炎病毒 基因型为A–H的乙型肝炎病毒
查看图表

原理

artus HBV Kits的原理是使用real-time PCR技术,扩增和检测乙型肝炎病毒基因组中一段特定序列。该试剂盒特异性强、灵敏度高(参见" Highly sensitive detection of HBV DNA"),且重复性好。每个artus HBV Kit都包含5个乙型肝炎病毒标准品(参见" Reliable quantitation of HBV load")。使用这些标准品可确保准确定量病毒。此外,该试剂盒还含有异源扩增系统,即内参,可识别PCR抑制剂。内参(IC)可在PCR中通过不同的荧光通道检测,而不会降低乙型肝炎病毒的检测灵敏度。

artus HBV RG PCR Kit和artus HBV QS-RGQ Kit的规格
试剂盒 artus HBV RG PCR Kit和artus HBV QS-RGQ Kit
经验证的适用样本类型 EDTA血浆
扩增子 乙型肝炎病毒基因组一段长为134 bp的核心序列
查看图表

程序

artus HBV PCR Kits包含对乙型肝炎病毒DNA进行可靠定量检测的所有所需试剂,并已经过优化。只需在即用型PCR预混液加入模板DNA(如使用LC试剂盒,需要在Mg溶液中也加入),即可按照试剂盒操作手册中的优化程序,在real-time PCR仪上开始反应。

完整的自动化检测体系,覆盖样本制备到乙型肝炎病毒检测

QIAsymphony RGQ的乙型肝炎病毒检测解决方案包括:使用QIAsymphony SP进行样本制备,使用QIAsymphony AS进行反应体系构建,并在Rotor-Gene Q实时荧光定量PCR分析仪上使用artus HBV QS-RGQ Kit进行检测。这一体系不仅可可靠检测病原体,而且完全符合体外诊断CE要求(参见" Integrated QIAsymphony RGQ system for HBV detection")。

用于手动纯化病毒RNA的推荐产品

artus HBV LC、RG和TM PCR Kits已经过验证,适用于CE认证的QIAamp DSP Virus Kit从EDTA血浆中纯化得到的病毒RNA。

查看图表

应用

artus HBV RG、LC和TM PCR Kits可快速、灵敏的定量检测使用QIAamp DSP Virus Kit从人类血浆中纯化得到的乙型肝炎病毒DNA。这些试剂盒适用于ABI PRISM 7000、7700和7900HT SDS,LightCycler 1.1/1.2/1.5/2.0 Instruments或Rotor-Gene Q实时荧光定量PCR分析仪。

artus HBV QS-RGQ Kit适用于QIAsymphony RGQ仪器,整个工作流程覆盖样本制备到乙型肝炎病毒DNA定量检测,完全符合体外诊断CE要求。

辅助数据和图表

资源

安全数据表 (1)
Download Safety Data Sheets for QIAGEN product components.
实验方案软件 (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
仪器技术参数 (1)
Information document for software version 4.0
Safety Data Sheets (1)
Certificates of Analysis (1)
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