text.skipToContent text.skipToNavigation

artus HCV RT-PCR Kits CE

For quantitative detection of HCV specific RNA using real-time RT-PCR
  • Complete CE-IVD-compliant 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
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.
Cat No./ID: 4518263
artus HCV RG RT-PCR Kit (24)
For 24 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4518265
artus HCV RG RT-PCR Kit (96)
For 96 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4518363
artus HCV QS-RGQ Kit (24)
For 24 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4518366
artus HCV QS-RGQ Kit (72)
For 72 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
artus HCV RT-PCR Kits CE are intended for in-vitro diagnostic use in Europe. Not available in the USA.

0
In vitro diagnostic medical device.
1
CE-IVD-marked.
2
Reliable quantitation of HCV load.
Detection of the quantitation standards (Hep. C Virus RG QS 1–4) in fluorescence channel Cycling Green. NTC: No template control (negative control).
3
Integrated QIAsymphony RGQ system for HCV detection.
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)
HCV titer (IU/ml)  Total replicate number  Total number positive Percentage of positives
Probit analysis    
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 CE-IVD-compliant 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 CE-marked 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 CE-IVD-compliant workflow from sample to HCV RNA detection and quantitation.

You are not authorized to download the resource

Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
Show details
Instrument Technical Documents (1)
Information document for software version 4.0
Show details
fragment fix placeholder

Customers who bought these products also bought