artus HI Virus-1 RT-PCR Kits CE

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.

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.

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.

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.

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.