artus HI Virus-1 RT-PCR Kits CE

• Full compliance with EU IVD Directive 98/79/EC
• 67 IU/ml 까지 검출 가능한 고감도
• HIV-1의 genotype A부터 H까지 specific detection이 가능
• Internal control을 이용하여 신뢰할 수 있는 결과 얻어냄
• Accurate quantitation of viral load over a very broad range

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.