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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.
Cat No./ID: 4506163
artus HBV TM PCR Kit (24) CE
For 24 reactions on the ABI PRISM 7000, 7700, 7900HT SDS: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4506165
artus HBV TM PCR Kit (96) CE
For 96 reactions on the ABI PRISM 7000, 7700, 7900HT SDS: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4506263
artus HBV RG PCR Kit (24) CE
For 24 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4506265
artus HBV RG PCR Kit (96) CE
For 96 reactions on Rotor-Gene Q instruments: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4506363
artus HBV QS-RGQ Kit (24) CE
For 24 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4506366
artus HBV QS-RGQ Kit (72) CE
For 72 reactions on the QIAsymphony RGQ: Master, 5 Quantitation Standards, Internal Control, Water (PCR grade)

artus HBV PCR Kits CE are intended for in vitro diagnostic use in Europe.


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Reliable quantitation of HBV load.
Detection of the quantitation standards (HBV RG/TM 1–5) on the Rotor-Gene using the artus HBV RG PCR Kit. NTC: no template control.
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Hepatitis B virus.
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Highly sensitive detection of HBV DNA.
Probit analysis: HBV (QIAsymphony RGQ system). Analytical sensitivity of the artus HBV QS-RGQ Kit with the QIAsymphony RGQ system.
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CE-IVD-marked.
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In vitro diagnostic medical device.
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Integrated QIAsymphony RGQ system for HBV detection.
Performance

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
Principle

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
Procedure

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.

Applications

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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Additional Resources (1)
Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
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Instrument Technical Documents (1)
Information document for software version 4.0
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