artus HBV PCR Kits CE

For quantitative detection of hepatitis B virus DNA using real-time PCR

Products

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

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)

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)

1.042,00 €

Quantity

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)

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)

Features

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

Product Details

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.

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 Kit	artus 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

See figures

Highly sensitive detection of HBV DNA.

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

See figures

Highly sensitive detection of HBV DNA.

Reliable quantitation of HBV load.

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.

See figures

Integrated QIAsymphony RGQ system for HBV detection.

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.