QIAstat-Dx Meningitis/Encephalitis Panel (IVDR)

QIAstat-Dx Meningitis/Encephalitis Panel – Qualitative test to analyze 16 of the most common targets causing central nervous system infections (meningitis and encephalitis).

*Cryptococcus neoformans/Cryptococcus gattii are both detected, but not differentiated, with the QIAstat-Dx Meningitis/Encephalitis Panel.

6 individually packaged cartridges containing all reagents needed for sample preparation and multiplex real-time RT-PCR, plus internal control, including six transfer pipettes.

Features

• Intuitive workflow with minimal hands-on time
• Uses real-time PCR to deliver comprehensive results in about an hour
• Easily view Ct values and amplification curves for all detected pathogens
• No precision pipetting required and unique direct swab protocol for input into the cartridge
• QIAsphere-connected for real-time updates, proactive remote service and custom epidemiology reports

Principle

The QIAstat-Dx Analyzers 1.0 and 2.0, combined with QIAstat-Dx assay cartridges, use real-time PCR to detect pathogen nucleic acids in human biological samples. The cartridges are designed as closed systems containing the necessary reagents for automated sample processing, following a simple sample preparation and loading step. Detected real-time amplification signals are interpreted by the integrated software and are reported via an intuitive user interface.

Procedure

Setting up and running a QIAstat-Dx test requires minimal hands-on time and just a few simple steps.

1. Add the patient sample to the main port of the QIAstat-Dx cartridge using the plastic pipette provided. For our respiratory panels, you can alternatively apply the sample with a dry swab. This step is fast and easy to perform and requires no precision pipetting.
2. Press the Run Test button on the QIAstat-Dx touch screen and scan the sample ID barcode.
3. Scan the barcode of the cartridge you’re using.
4. Position the cartridge on the instrument’s sample port. The cartridge will automatically move in and the test will start.
5. After about an hour, view the comprehensive results.

Documents

• QIAstat-Dx Meningitis/Encephalitis (ME) Panel Instructions for Use (IVDR)
• QIAstat-Dx Meningitis/Encephalitis (ME) Panel Summary of Safety and Performance
• Guidelines for Laboratory Verification of Performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel (IVDR)

Ordering Information

The QIAstat-Dx instruments and QIAstat-Dx panels are intended for in vitro diagnostic use.

For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit instructions for use or user manual. QIAGEN instructions for use and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services (or your local distributor).

Product availability may differ from country to country based on regulations and approvals. Contact your country representative for further details.