artus HBV PCR Kits CE

For quantitative detection of hepatitis B virus DNA using real-time PCR
  • Complete CE-IVD-compliant workflow (QIAsymphony RGQ)
  • High reliability using the internal control
  • Highly sensitive detection of as few as 10.2 IU/ml (QS-RGQ kit)
  • Broad linear range from 31.6 to more than 20,000,000 IU/ml (QS-RGQ kit)
  • Accurate quantitation using the 5 standards supplied
artus HBV PCR Kits are ready-to-use molecular detection kits for real-time PCR. All necessary reagents optimized for reliable HBV DNA detection and quantitation, including genotypes A–H for in vitro diagnostic use, are provided. The artus HBV QS-RGQ Kit is used with QIAsymphony RGQ, the automated system for pathogen detection, and is not for use with manual assay setup. The artus HBV RG and TM PCR Kits use manual sample preparation and assay setup techniques.
产品 货号 目录价:
artus HBV QS-RGQ Kit (24) CE
For 24 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
4506363
询价
artus HBV QS-RGQ Kit (72) CE
For 72 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
4506366
询价
artus HBV RG PCR Kit (24) CE
For 24 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
4506263
询价
artus HBV RG PCR Kit (96) CE
For 96 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
4506265
询价

artus HBV PCR Kits CE可在欧洲用于体外诊断。


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HBV病毒载量的可靠定量。|乙肝病毒。|HBV病毒DNA的高敏感度检测。|CE体外诊断认证。|在某些国家可用于体外诊断。|可使用QIAsymphony RGQ自动化检测HBV病毒。|
在Rotor-Gene Q实时荧光定量PCR分析仪上使用artus HBV RG PCR Kit检测定量标准品(HBV RG/TM 1–5)。NTC:无模板对照。||概率分析:HBV(Rotor-Gene Q实时荧光定量PCR分析仪)。artus HBV QS-RGQ Kit与QIAsymphony RGQ仪器共同使用的分析敏感度。||||
性能

To ensure highest sensitivity, artus HBV Kits have been optimized to detect low numbers of HBV DNA. The analytical sensitivity of the artus HBV QS-RGQ Kit is 10.2 IU/ml in consideration of the purification and assay setup using the QIAsymphony RGQ system (see figure "Highly sensitive detection of HBV DNA"). (1 IU/ml corresponds to 8.21 copies/ml for detection of HBV DNA on the Rotor-Gene Q. The conversion factor is an approximation based on an average factor across the assay's dynamic range.)

For highest specificity, validation of the artus HBV Kits was carried out using various HBV isolates, including all genotypes A–H and related pathogens.

Performance characteristics of artus HBV RG PCR Kit and artus HBV QS-RGQ Kit
Kit  artus HBV RG PCR Kitartus HBV QS-RGQ Kit
Validated sample type  EDTA plasma EDTA plasma
Analytical sensitivity  3.8 IU/ml 10.2 IU/ml
 Linear range  1.1 to >4 x 109 IU/ml  31.6 to >2 x 107 IU/ml
 Specificity  HBV genomes A–H  HBV genomes A–H
原理

artus HBV Kits are based on the amplification and simultaneous detection of a specific region of the HBV genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure "Highly sensitive detection of HBV DNA"), and reproducibility over a broad linear range.
Each artus HBV Kit provides 5 HBV quantitation standards (see figure "Reliable quantitation of HBV load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contains a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical HBV PCR is not reduced.

Specifications of artus HBV RG PCR Kit and artus HBV QS-RGQ Kit
Kitartus HBV RG PCR Kit and artus HBV QS-RGQ Kit
Validated sample type EDTA plasma
Amplicon 134 bp core region of the HBV genome
操作流程

artus HBV PCR Kits provide all necessary reagents optimized for reliable HBV DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Complete automated system from sample to HBV detection

The QIAsymphony RGQ workflow solution for HBV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus HBV QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a complete CE-IVD-compliant workflow (see figure "Integrated QIAsymphony RGQ system for HBV detection").

Recommendations for manual viral RNA purification

artus HBV RG and TM PCR Kits are validated for use with viral RNA purified from EDTA plasma using the CE-marked QIAamp DSP Virus Kit.

应用

artus HBV RG and TM PCR Kits enable rapid and sensitive detection and quantitation of HBV DNA purified from human plasma using the QIAamp DSP Virus Kit. Kits are available for use on the ABI PRISM 7000, 7700 and 7900HT SDS, or on Rotor-Gene Q instruments.

The artus HBV QS-RGQ Kit is designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from sample to HBV DNA detection and quantitation.

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实验方案软件
1
For use with QIAsymphony SP/AS instruments (software version 4.0)
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仪器技术参数
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安全数据表
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Download Safety Data Sheets for QIAGEN product components.
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图片
Reliable quantitation of HBV load
HBV病毒载量的可靠定量。
在Rotor-Gene Q实时荧光定量PCR分析仪上使用artus HBV RG PCR Kit检测定量标准品(HBV RG/TM 1–5)。NTC:无模板对照。
Hepatitis B virus
乙肝病毒。
Highly sensitive detection of HBV DNA
HBV病毒DNA的高敏感度检测。
概率分析:HBV(Rotor-Gene Q实时荧光定量PCR分析仪)。artus HBV QS-RGQ Kit与QIAsymphony RGQ仪器共同使用的分析敏感度。
CE-IVD marked Symbol
CE体外诊断认证。
SYM_0002_IVD
在某些国家可用于体外诊断。
Integrated QIAsymphony RGQ system for HBV detection
可使用QIAsymphony RGQ自动化检测HBV病毒。