artus HI Virus-1 RT-PCR Kits CE

For quantitative detection of HIV-1 specific RNA using real-time PCR
  • 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
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.
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artus HI Virus-1 QS-RGQ Kit (72) CE
For 72 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
4513366
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artus HI Virus-1 RG RT-PCR Kit (24) CE
For 24 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
4513263
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artus HI Virus-1 RG RT-PCR Kit (96) CE
For 96 reactions on Rotor-Gene Q instruments: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
4513265
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artus HI Virus-1 QS-RGQ Kit (24) CE
For 24 reactions on the QIAsymphony RGQ: 2 Masters, 4 Quantitation Standards, Internal Control, Water (PCR grade)
4513363
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artus HI Virus-1 RT-PCR Kits CE are intended for in vitro diagnostic use in Europe.


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Reliable quantitation of HIV-1 load.|HIV-1.|Highly sensitive detection of HIV-1 RNA.|CE-IVD-marked.|In vitro diagnostic medical device.|Integrated QIAsymphony RGQ system for HIV-1 detection.|
The quantitation standards (HI Virus-1 RG QS 1–4) are detected in fluorescence channel Cycling Green of the Rotor-Gene Q/6000 or A.FAM of the Rotor-Gene 3000. NTC: no template control (negative control).

  ||Probit analysis: HI Virus-1 (QIAsymphony RGQ system). Analytical sensitivity of the artus HI Virus-1 QS-RGQ Kit with the QIAsymphony RGQ system.||||

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

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

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.

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.

Feature
Specifications
Quantitative/qualitative Quantitative
Recommended sample prep QIAamp DSP Virus Kit
RUO/CE/ASR CE
Sample type EDTA plasma
Thermal cycler Rotor-Gene 6000
What detected Human Immunodeficiency Virus type 1 RNA

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Protocol Files
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For use with QIAsymphony SP/AS instruments (software version 4.0)
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Instrument Technical Documents
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