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artus MRSA/SA QS-RGQ Kit CE

For qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA
  • CE-IVD-compliant, automated workflow on the QIAsymphony RGQ
  • High reliability through use of an internal control
  • Excellent detection limit for human nasal swabs
The artus MRSA/SA QS-RGQ Kit delivers sensitive and specific detection of MRSA (mecA/mecC) and SA (Idh1) DNA giving you the definitive results you need. The kit is a ready-to-use PCR assay for use on the QIAsymphony RGQ and provides all necessary reagents optimized for the direct qualitative detection of MRSA and SA DNA in human nasal swabs for in vitro diagnostic use.
Cat No./ID: 4570366
artus MRSA/SA QS-RGQ Kit (72) CE
For 72 reactions: 3 Masters, 6 Positive Controls, Internal Control, Negative Control

The artus MRSA/SA QS-RGQ Kit CE is intended for in vitro diagnostic use in Europe.


Performance
See the online Performance Characteristics.
Principle
The artus MRSA/SA QS-RGQ Kit constitutes a ready-to-use system for the detection of MRSA/SA DNA using real-time PCR on Rotor-Gene Q instruments with sample preparation and assay setup using QIAsymphony SP/AS instruments. The MRSA/SA Master contains reagents and enzymes for the specific amplification and direct detection of target regions within the methicillin-resistance genes mecA and mecC, as well as within the SA-specific gene, Idh1. This unique assay design combined with the ΔCT value algorithm used by Rotor-Gene AssayManager ensures accurate results.
The mecA and mecC targets are detected in fluorescence channel Cycling Green, and the Idh1 target is detected in fluorescence channel Cycling Orange of Rotor-Gene Q instruments.
In addition, the artus MRSA/SA QS-RGQ Kit contains a second heterologous control system to identify potential failures during the entire assay process. This is detected as an internal control (IC) in fluorescence channel Cycling Crimson of Rotor-Gene Q instruments.
Procedure
The QIAsymphony RGQ complete workflow solution for detection of MRSA/SA DNA comprises the QIAsymphony SP and QIAsymphony DSP Virus/Pathogen Midi Kit for sample preparation, the QIAsymphony AS for assay setup, the artus MRSA/SA QS-RGQ Kit on Rotor-Gene Q instruments for detection, and Rotor-Gene AssayManager for automated interpretation of results. The system enables reliable pathogen DNA detection with a complete CE-IVD-compliant workflow.
Applications
The artus MRSA/SA QS-RGQ Kit enables rapid and sensitive detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphlyococcus aureus (SA) using DNA purified from human nasal swabs. The test is intended to aid in the prevention and control of MRSA infections in healthcare settings.
The artus MRSA/SA QS-RGQ Kit is designed to be used with the QIAsymphony RGQ, providing a complete CE-IVD-compliant workflow, from sample to result.

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Protocol Files (2)

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Validation is not required for the QIAGEN CE-IVD compliant artus MRSA/SA QS-RGQ workflow. This new application has no impact on other installed/validated applications on the QIAsymphony SP/AS or on Rotor-Gene AssayManager. However, validation may be required for other downstream applications, laboratory-developed tests, or other commercial assays, etc.
Note: In none of these cases, is the customer/user released from internal quality assessment in accordance with applicable laws, directives, regulations, and standards. It is the user’s sole responsibility to validate system performance for any procedures used in their laboratory that are not covered by the QIAGEN performance evaluation studies.
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