Description
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.
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 10 9 IU/ml 31.6 to >2 x 10 7 IU/ml Specificity HBV genomes A–H HBV genomes A–H
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
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.
