artus HCV PCR Kits

For quantitative detection of HCV specific RNA using real-time RT-PCR

Products

artus HCV RT-PCR Kits CE are intended for in-vitro diagnostic use.

artus HCV RG RT-PCR Kit (96)

Cat. No. / ID: 4518265

For 96 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)

artus HCV QS-RGQ Kit (72)

Cat. No. / ID: 4518366

For 72 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)

artus HCV QS-RGQ Kit (24)

Cat. No. / ID: 4518363

For 24 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)

1412,00 CHF

Quantity

artus HCV QS-RGQ Kit (72) CE

Cat. No. / ID: 4538366

Version 2 kit for 72 reactions: Master A and B, internal control, Hepatitis C Virus Quantification Standards 1 to 4, and PCR grade water. For use with QIAsymphony SP/AS and Rotor-Gene Q instruments

4106,00 CHF

Quantity

artus HCV RG RT-PCR Kit (24)

Cat. No. / ID: 4518263

For 24 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)

Features

Complete CE-IVD-compliant workflow from sample to quantitative detection
High reliability using the internal control
Accurate quantification using the 4 standards supplied

Product Details

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).

References

1. European Association for Study of the Liver (2018). EASL recommendations on treatment of Hepatitis C 2018. J. Hepatol., 69, 461

Performance

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)
	artus HCV RG RT-PCR Kit	Version 1 of the artus HCV QS-RGQ Kit	Version 2 of theartus HCV QS-RGQ Kit
Validated sample type	EDTA plasma	EDTA plasma	EDTA plasma
Design and genotype coverage	240 bp region in HCV genotypes 1 to 6	240 bp region in HCV genotypes 1 to 6	69 bp region in HCV genotypes 1 to 6
Limit of Detection	34 IU/ml	21 IU/ml	≤15 IU/ml
Linear range	65 to 1 x 10⁶ IU/ml	35 to 1.77 x 10⁷ IU/ml	15 IU/ml to 1 x 10⁸ IU/ml

Principle

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.

Procedure

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.

Applications

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.

Supporting data and figures

In vitro diagnostic medical device.

Integrated QIAsymphony RGQ system for HCV detection.

Resources

Information document for software version 4.0

For use with QIAsymphony SP/AS instruments (software version 4.0)

For use with version 2 of the artus HCV QS-RGQ Kit

For use with version 2 kits

Download Safety Data Sheets for QIAGEN product components.

FAQ

Since May 2002 artus has produced and inspected its products in accordance with the European guidelines (directives, standards) for in vitro diagnostics (directive 98/79/EG IVD).

Thus, they are allowed to carry the CE-label (directive 93/42/EWG MPG). A prerequisite for this is the maintenance of a certified quality management system according to DIN EN ISO 9001 as well as a running quality and conformation control for each lot produced.

FAQ ID -1372