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artus BK Virus PCR Kits CE

利用real-time PCR方法定量检测BK病毒的特异性DNA

Products

artus BK Virus PCR Kits CE 旨在用于欧洲体外诊断用途。
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artus BK Virus QS-RGQ Kit (24) CE

Cat. No. / ID:   4514363

For 24 reactions on the QIAsymphony RGQ: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)
€1,550.00
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artus BK Virus RG PCR Kit (24) CE

Cat. No. / ID:   4514263

For 24 reactions on Rotor-Gene Q instruments: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)
€1,772.00
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artus BK Virus RG PCR Kit (96) CE

Cat. No. / ID:   4514265

For 96 reactions on Rotor-Gene Q instruments: Master, 4 Quantitation Standards, Internal Control, Mg Solution, Water (PCR grade)
€6,757.00

特点

  • 整个工作流程(QAIAsymphony RGQ)均符合CE-IVD要求
  • 使用内参,检测可靠性高
  • 检测灵敏度高,可检测26.7个拷贝/ml(QS-RGQ kit)
  • 提供4个标准品,可进行准确定量

产品详情

artus BK Virus RG PCR Kit和artus BK Virus QS-RGQ Kit是即用型分子检测试剂盒,可在Roto-Gene实时荧光定量PCR分析仪上用于real-time PCR反应。试剂盒中含有所有所需的试剂,并且这些试剂已经过优化,可快速、灵敏的检测BK病毒的特异性DNA,准确定量检测病毒量,适用于体外诊断。artus BK Virus RG PCR Kit使用自动化样本制备和手动反应体系构建技术。artus BK Virus QS-RGQ Kit可用于QIAsymphony RGQ,这是一个完整的自动化系统,覆盖样本制备到病原体检测的完整工作流程,无需进行手工反应体系构建。

绩效

为确保高灵敏度,artus BK Virus Kit已经过优化,可检测到低拷贝数的BK病毒DNA。用QIAsymphony RGQ构建反应体系,利用artus BK Virus QS-RGQ Kit检测血浆的分析灵敏度为26.7拷贝/毫升(参见" Highly sensitive detection of BK virus DNA")该试剂盒对相关BK病毒株系的特异性已经过验证。

artus BK Virus Kits的性能特征
试剂盒  artus BK Virus RG PCR Kit artus BK Virus QS-RGQ Kit
经过验证的适用样本类型  人类血浆或尿液  人类血浆或尿液
分析灵敏度  在PCR反应中为0.195拷贝/μl  在血浆中为26.7拷贝/ml
线性范围  n.d.  5.00 x 101至9.26 x 107拷贝/ml(血浆)
特异性  BK病毒(Dunlop、Gardner、AB269822和S72390株系的病毒已经过验证)  BK病毒(Dunlop、Gardner、AB269822和S72390株系的病毒已经过验证)
n.d.:未确定。
查看图表

原理

artus BK Virus RG PCR Kit和artus BK Virus QS-RGQ Kit的原理均为使用real-time PCR技术对BK病毒基因组特定片段进行扩增和实时检测。该试剂盒特异性强、灵敏度高(参见" Highly sensitive detection of BK virus DNA"),且重复性好。

每个artus BK Virus Kit中都包含4个BK病毒标准品(参见" Reliable quantitation of BK virus 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BK病毒PCR的检测灵敏度。

artus BK Virus Kits的规格
试剂盒 artus BK Virus RG PCR Kit和artus BK Virus QS-RGQ Kit
经过验证的适用样本类型 人类血浆和尿液
扩增子 VP2和VP3基因间的长为274 bp的序列
查看图表

程序

artus BK Virus Kits包含对BK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预混液和Mg溶液中加入模板DNA,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。

多个试剂盒的反应温度相近,一次检测可进行多个分析

artus BK Virus Kits的反应温度与artus RG PCR Kits和artus QS-RGQ Kits检测EBV、CMV、HSV-1/2和VZV的温度相应。因此可一次进行多个PCR分析。

完整的自动化检测体系,覆盖样本制备到BK病毒检测

QIAsymphony RGQ的BK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 BK Virus 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 BK virus detection")。

如使用artus BK Virus RG PCR Kit,推荐用以下产品纯化病毒DNA

artus BK Virus RG PCR Kit经过验证,可与EZ1 DSP Virus Kit共同使用。artus BK Virus RG PCR Kit令有经体外诊断CE认证的EASYartus BK Virus RG PCR Kits,其中包含用于自动纯化病毒核酸的EZ1 DSP Virus Kit。

查看图表

应用

使用artus BK Virus RG PCR Kit可从人类血浆或尿液样本中快速、灵敏、准确的定量检测BK病毒DNA。该试剂盒可在Rotor-Gene Q实时荧光定量PCR分析仪上使用。

artus BK Virus QS-RGQ Kit专为QIAsymphony RGQ设计,可从血浆或尿液样本中定量检测BK病毒DNA,整个工作流程符合体外诊断CE要求。

辅助数据和图表

资源

试剂盒操作手册 (2)
For use with Rotor-Gene Q Instruments
仪器技术参数 (1)
Information document for software version 4.0
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)
Safety Data Sheets (1)
Certificates of Analysis (1)

FAQ

Are artus® kits legally authorized?

Since May 2002 artus has produced and inspected its products in accordance with the European guidelines (directives, standards) for in vitro diagnostics (directive 98/79/EG IVD).

Thus, they are allowed to carry the CE-label (directive 93/42/EWG MPG). A prerequisite for this is the maintenance of a certified quality management system according to DIN EN ISO 9001 as well as a running quality and conformation control for each lot produced.

FAQ ID -1372
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