Description
artus CMV PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable CMV DNA detection and quantitation for in vitro diagnostic use. artus CMV RG and TM PCR Kits use manual sample preparation and assay setup techniques. The artus CMV LC PCR Kit uses automated or manual sample preparation and manual asssay setup techniques. The artus CMV 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 CMV Kits have been optimized to detect low numbers of CMV DNA. The analytical sensitivity of the artus CMV QS-RGQ Kit is 42.5 copies/ml in consideration of the purification from EDTA plasma and assay setup using the QIAsymphony RGQ (see figure "Highly sensitive detection of CMV DNA"). (1.00 copies/ml corresponds to 1.64 IU/ml for detection of CMV DNA in EDTA plasma on the Rotor-Gene Q in combination with automated sample preparation and assay setup using the QIAsymphony RGQ. The conversion factor was determined by a regression analysis of multiple dilution series of the 1st WHO International Standard compared against a reference method reporting in IU/ml.) Performance characteristics of artus CMV RG PCR Kit and artus CMV QS-RGQ Kit Kit artus CMV RG PCR Kit artus CMV QS-RGQ Kit Validated sample type EDTA plasma EDTA plasma or whole blood Analytical sensitivity 57.1 copies/ml 42.5 copies/ml (plasma, corresponding to 69.7 IU/ml) Linear range n.d. 79.4 to 1.00 x 10 8 copies/ml (plasma, corresponding to 1.30 x 10 2 to 1.64 x 10 8 IU/ml) n.d.: not determined.
artus CMV Kits are based on the amplification and simultaneous detection of a specific region of the CMV genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure "Highly sensitive detection of CMV DNA"), and reproducibility. Each artus CMV Kit provides 4 CMV quantitation standards (see figure "Reliable quantitation of CMV load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contain 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 CMV PCR is not reduced. Specifications of artus CMV RG PCR Kit and artus CMV QS-RGQ Kit Kit artus CMV RG PCR Kit artus CMV QS-RGQ Kit Validated sample type EDTA plasma EDTA plasma or whole blood Amplicon 105 bp region of the major immediate early (MIE) gene 105 bp region of the major immediate early (MIE) gene
artus CMV PCR Kits provide all necessary reagents optimized for reliable CMV DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix and Mg solution, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook. Common temperature profiles for multiple assays in one run The temperature profile of artus CMV RG PCR Kit and the artus CMV QS-RGQ Kit corresponds to the profiles of the artus RG PCR Kits and artus QS-RGQ Kits for BK virus, EBV, HSV-1/2, and VZV. Therefore, these PCR assays can be performed and analyzed in a single run. Complete automated system from sample to CMV detection The QIAsymphony RGQ workflow solution for CMV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus CMV 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 CMV detection"). Recommendations for viral DNA purification when using the artus CMV LC, RG, or TM PCR Kits The artus TM PCR Kit is validated for use with the QIAamp DSP Virus Kit. With the artus CMV RG and LC PCR Kits, either the QIAamp DSP Virus Kit or the EZ1 DSP Virus Kit can be used. The artus CMV RG PCR Kit is also available as CE-IVD-marked EASY artus CMV RG PCR Kits, which include the EZ1 DSP Virus Kit for automated viral nucleic acid purification.
