artus HCV RT-PCR kits

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

Products

The artus HCV RT-PCR kits are intended for in vitro diagnostic use.

artus HCV QS-RGQ Kit (72)

Cat. No. / ID: 4518356

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

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artus HCV RG RT-PCR Kit (24)

Cat. No. / ID: 4518253

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

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Features

Complete IVD workflow (QIAsymphony RGQ)
High reliability using the internal control
Highly sensitive detection of as few as 21 IU/ml
Accurate quantitation of viral load over a very broad linear range

Product Details

The artus HCV RG RT-PCR Kit and 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 detection and 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.

Performance

To ensure highest sensitivity, artus HCV Kits have been optimized to detect low numbers of HCV RNA. The analytical sensitivity of the artus HCV QS-RGQ Kits is 21 IU/ml in consideration of the purification and assay setup using the QIAsymphony RGQ system (see table "Hit rate analysis for HCV LOD study (data was used for probit analysis and verification study)" below). (1 IU/ml corresponds to 1.21 copies/ml for detection of HCV RNA on the QIAsymphony RGQ system. The conversion factor is an approximation based on an average factor across the assay's dynamic range.)

Hit rate analysis for HCV LOD study (data was used for probit analysis and verification study)
Probit analysis
HCV titer (IU/ml)	Total replicate number	Total number positive	Percentage of positives
150	12	12	100
100	12	12	100
50	12	12	100
30	32	32	100
20	60	59	98
15	60	51	85
5	60	40	67
0.316	57	3	5
Verification
20	60	57	95.00

For highest specificity, validation of the artus HCV Kits was carried out using various HCV isolates, including all genotypes 1–6 and related pathogens.

Performance characteristics of *artus* HCV Kits
Kit	artus HCV RG RT-PCR Kit	artus HCV QS-RGQ Kit
Validated sample type	EDTA plasma	EDTA plasma
Analytical sensitivity	34 IU/ml	21 IU/ml
Linear range	65 to 1 x 10⁶ IU/ml	35.0 to 1.77 x 10⁷ IU/ml
Specificity	HCV genotypes 1–6	HCV genotypes 1–6

Principle

The artus HCV RG RT-PCR Kit and the artus HCV QS-RGQ Kit 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 (see figure "Reliable quantitation of HCV 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 HCV PCR is not reduced.

Specifications of *artus* HCV Kits
Kit	artus HCV RG RT-PCR Kit and artus HCV QS-RGQ Kit
Validated sample type	EDTA plasma
Amplicon	240 nt region of the 5' UTR

Procedure

artus HCV RT-PCR Kits provide all necessary reagents optimized for reliable HCV RNA detection and 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 detection with a complete IVD workflow (see figure "Integrated QIAsymphony RGQ system for HCV detection").

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 IVD-validated QIAamp DSP Virus Kit.

Applications

The artus HCV RG RT-PCR Kit enables rapid and sensitive detection and quantitation of HCV RNA purified from human plasma using the QIAamp DSP Virus Kit.

The artus HCV QS-RGQ Kit is designed to be used with the QIAsymphony RGQ system, providing a complete IVD workflow from sample to HCV RNA detection and quantitation.