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artus HI Virus-1 RT-PCR Kits CE

For quantitative detection of HIV-1 specific RNA using real-time PCR

Features

  • Complete CE-IVD-compliant workflow from sample to detection
  • High reliability using the internal control
  • Highly sensitive detection of as few as 76.4 IU/ml
  • Specific detection of HIV-1 genotypes A to H
  • Accurate quantitation of viral load over a very broad range

Products

artus HI Virus-1 RT-PCR Kits CE are intended for in vitro diagnostic use in Europe.
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artus HI Virus-1 QS-RGQ Kit (72) CE

Cat. No. / ID: 4513366

For 72 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€2,403.00
Add to cart
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artus HI Virus-1 RG RT-PCR Kit (24) CE

Cat. No. / ID: 4513263

For 24 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€789.00
Add to cart
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artus HI Virus-1 RG RT-PCR Kit (96) CE

Cat. No. / ID: 4513265

For 96 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€2,991.00
Add to cart
Image
artus HI Virus-1 QS-RGQ Kit (24) CE

Cat. No. / ID: 4513363

For 24 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
€803.00
Add to cart

Product Details

The artus HI Virus-1 RG RT-PCR Kit and the artus HI Virus-1 QS-RGQ Kit are ready-to-use molecular detection kits for real-time RT-PCR on Rotor-Gene Q instruments. The kits provide all necessary reagents optimized for reliable HIV-1 RNA detection and quantitation for in vitro diagnostic use. The artus HI Virus-1 RG RT-PCR Kit uses manual sample preparation and assay setup techniques. The artus HI Virus-1 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 HI Virus-1 Kits have been optimized to detect low numbers of HIV-1 RNA. The analytical sensitivity of the artus HI Virus-1 QS-RGQ Kits is 76.4 IU/ml in consideration of the purification and assay setup using the QIAsymphony RGQ system (see figure " Highly sensitive detection of HIV-1 RNA"). (1 IU/ml corresponds to 0.45 copies/ml for detection of HIV-1 RNA 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 HI Virus-1 Kits was carried out using various HIV-1 isolates, including all group M subtypes A–H, and related pathogens.

Performance characteristics of artus HI Virus-1 Kits
Kit  artus HI Virus-1 RG RT-PCR Kitartus HI Virus-1 QS-RGQ Kit
Validated sample type  Human EDTA plasma Human EDTA plasma
Analytical sensitivity  66.9 IU/ml 76.4 IU/ml (corresponding to 34.4 copies/ml)
 Linear range  120 to >1 x 108 IU/ml  1 x 102 to 1 x 108 IU/ml (corresponding to 4.5 x 101 to 4.5 x 107 copies/ml)
 Specificity  HIV-1, including all group M subtypes A–H  HIV-1, including all group M subtypes A–H

See figures

Principle

The artus HI Virus-1 RG RT-PCR Kit and the artus HI Virus-1 QS-RGQ Kit are based on the amplification and simultaneous detection of a specific region of the HIV-1 genome using real-time RT-PCR. The kits provide high levels of specificity, sensitivity (see figure " Highly sensitive detection of HIV-1 RNA"), and reproducibility over a broad linear range.
Each artus HI Virus-1 Kit provides 4 HIV-1 quantitation standards (see figure " Reliable quantitation of HIV-1 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 HIV-1 PCR is not reduced.

Specifications of artus HI Virus-1 Kits
Kitartus HI Virus-1 RG RT-PCR Kit and artus HI Virus-1 QS-RGQ Kit
Validated sample type Human EDTA plasma
Amplicon 93 nt region of the 5' LTR

See figures

Procedure

artus HI Virus-1 RT-PCR Kits provide all necessary reagents optimized for reliable HIV-1 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 HIV-1 detection

The QIAsymphony RGQ workflow solution for HIV-1 detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus HI Virus-1 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 HIV-1 detection").

Recommendations for manual viral RNA purification

The artus HI Virus-1 RG RT-PCR Kit is validated for use with viral RNA purified from human plasma using the CE-marked QIAamp DSP Virus Kit.

See figures

Applications

The artus HI Virus-1 RG RT-PCR Kit enables rapid and sensitive detection and quantitation of HIV-1 RNA purified from human plasma using the QIAamp DSP Virus Kit.

The artus HI Virus-1 QS-RGQ Kit is designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from sample to HIV-1 RNA detection and quantitation.

Supporting data and figures

Specifications

FeaturesSpecifications
quantitativequalitativeQuantitative
whatdetectedHuman Immunodeficiency Virus type 1 RNA
ruoceasrCE
sampletypeEDTA plasma
recommendedsampleprepQIAamp DSP Virus Kit
thermalcyclerRotor-Gene 6000

Resources

Additional Resources (1)
Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
Instrument Technical Documents (1)
Information document for software version 4.0

FAQ

Are artus® kits legally authorized?

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