artus HCV PCR Kits
For quantitative detection of HCV specific RNA using real-time RT-PCR
The artus HCV RG RT-PCR Kit and versions 1 and 2 of the artus HCV QS-RGQ Kit are ready-to-use molecular detection kits for real-time RT-PCR on Rotor-Gene instruments. The kits provide all necessary reagents optimized for reliable HCV RNA quantitation for in vitro diagnostic use. The artus HCV RG RT-PCR Kit uses manual sample preparation and assay setup techniques. The artus HCV QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup. The version 2 kit has been updated to meet the 2018 recommendations from EASL (1).
1. European Association for Study of the Liver (2018). EASL recommendations on treatment of Hepatitis C 2018. J. Hepatol., 69, 461
artus HCV RT-PCR Kits CE are intended for in-vitro diagnostic use.
To ensure highest sensitivity, this kit has been optimized to detect low numbers of HCV RNA. The Limit of Detection of the artus HCV QS-RGQ Kit is 21 IU/ml for version 1 and 15 IU/ml for version 2 using 1 ml of sample in the QIAsymphony RGQ system.
Performance characteristics of the artus HCV PCR Kits (CE)
The artus HCV RG RT-PCR Kit and the artus HCV QS-RGQ Kits are based on the amplification and simultaneous detection of a specific region of the HCV genome using real-time RT-PCR. The kits provide high levels of specificity, sensitivity, and reproducibility over a broad linear range.
Each artus HCV Kit provides 4 HCV quantitation standards. Use of the standards enables accurate quantitation of viral load. In addition, the kits contain 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 HCV PCR is not reduced.
artus HCV RT-PCR Kits provide all necessary reagents optimized for reliable HCV RNA quantitation. Simply add template RNA 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 HCV detection
The QIAsymphony RGQ workflow solution for HCV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus HCV QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen quantitation with a complete CE-IVD-compliant workflow.
Recommendations for manual viral RNA purification
The artus HCV RG RT-PCR Kit is validated for use with viral RNA purified from human plasma using the CE-marked QIAamp DSP Virus Kit.
artus HCV QS-RGQ Kits are designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from sample to HCV RNA quantitation.
The artus HCV RG RT-PCR Kit enables sensitive quantitation of HCV RNA purified from human plasma using the QIAamp DSP Virus Kit.
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