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artus HI Virus-1 RT-PCR Kits CE

使用real-time PCR定量检测HIV-1特异性RNA

Products

artus HI Virus-1 RT-PCR Kits CE 旨在用于欧洲体外诊断用途。
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artus HI Virus-1 QS-RGQ Kit (24) CE

Cat. No. / ID:   4513363

For 24 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€2,261.00
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artus HI Virus-1 QS-RGQ Kit (72) CE

Cat. No. / ID:   4513366

For 72 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€6,361.00
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artus HI Virus-1 RG RT-PCR Kit (24) CE

Cat. No. / ID:   4513263

For 24 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€2,172.00
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artus HI Virus-1 RG RT-PCR Kit (96) CE

Cat. No. / ID:   4513265

For 96 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€8,083.00

特点

  • 从样本制备到检测的工作流程符合CE体外诊断要求
  • 使用内参,具有高度可靠性
  • 灵敏度高,可达76.4 IU/ml
  • 特异性检测HIV-1病毒的A至H基因型
  • 在很大的病毒滴度范围内可确保准确检测

产品详情

artus HI Virus-1 RG RT-PCR Kit和artus HI Virus-1 QS-RGQ Kit为即用型分子检测试剂盒,适用于在Rotor-Gene Q实时荧光定量PCR分析仪上进行real-time RT-PCR检测。该试剂盒包含对HIV-1病毒RNA进行可靠检测的所有所需试剂,并已经过优化。artus HI Virus-1 RG RT-PCR Kit使用手动样本制备和反应体系构建技术。artus HI Virus-1 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 HI Virus-1 Kits已经过优化,可检测到低拷贝数的HIV-1病毒RNA。artus HI Virus-1 QS-RGQ Kits在QIAsymphony RGQ上使用的分析灵敏度为76.4 IU/ml(参见" Highly sensitive detection of HIV-1 RNA")。(1 IU/ml相当于在Rotor-Gene Q实时荧光定量PCR分析仪上检测到0.45拷贝/毫升的HIV-1病毒RNA。转化因子为平均值。)

为确保高度特异性,已使用多种HIV-1病毒,包括M组A至H基因型和相关病原体对artus HI Virus-1 Kits进行了验证。

artus HI Virus-1 Kits的性能特征
试剂盒  artus HI Virus-1 RG RT-PCR Kit artus HI Virus-1 QS-RGQ Kit
经过验证的适用样本类型  EDTA血浆  EDTA血浆
分析灵敏度  66.9 IU/ml  76.4 IU/ml
线性范围  120至>1 x 108 IU/ml  250至108 IU/ml
特异性  HIV-1病毒M组A–H基因亚型  HIV-1病毒M组A–H基因亚型
查看图表

原理

artus HI Virus-1 RG RT-PCR Kit和artus HI Virus-1 QS-RGQ Kit的原理是使用real-time RT-PCR技术,扩增并实时检测HIV-1病毒基因组一段特定序列。该试剂盒特异性强、灵敏度高(参见" Highly sensitive detection of HIV-1 RNA"),且重复性好。

每个artus HI Virus-1 Kit包含4个HIV-1病毒标准品(参见" Reliable quantitation of HIV-1 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HIV-1病毒的检测灵敏度。

artus HI Virus-1 Kits的规格
试剂盒 artus HI Virus-1 RG RT-PCR Kit和artus HI Virus-1 QS-RGQ Kit
经过验证的适用样本类型 EDTA血浆
扩增子 5' LTR一段长为93 nt的序列
查看图表

程序

artus HI Virus-1 RT-PCR Kits包含对HIV-1病毒RNA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预混液中加入模板RNA,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HIV-1病毒检测

QIAsymphony RGQ的HIV-1病毒检测解决方案包括:使用QIAsymphony SP核酸提取纯化分析仪进行样本制备,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 HI Virus-1 QS-RGQ Kit进行检测。这一体系不仅能够可靠检测病原体,而且完全符合体外诊断CE认证的要求(参见" Integrated QIAsymphony RGQ system for HIV-1 detection")。

用于手动纯化病毒RNA的推荐产品

artus HI Virus-1 RG RT-PCR Kit已经过验证,适用于CE认证的QIAamp DSP Virus Kit从人类血浆中纯化得到的病毒RNA。

查看图表

应用

artus HI Virus-1 RG RT-PCR Kit可快速、灵敏、准确的定量检测使用QIAamp DSP Virus Kit从人类血浆中纯化得到的HIV-1病毒RNA。

artus HI Virus-1 QS-RGQ Kit已经过验证,适用于QIAsymphony RGQ仪器,整个工作流程覆盖样本制备到HIV-1病毒RNA定量检测,符合CE体外诊断要求。

辅助数据和图表

Specifications

FeaturesSpecifications
Quantitative/qualitativeQuantitative
What detectedHuman Immunodeficiency Virus type 1 RNA
RUO/CE/ASRCE
Sample typeEDTA plasma
Recommended sample prepQIAamp DSP Virus Kit
Thermal cyclerRotor-Gene 6000

资源

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