QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics

QIAGEN has announced that the US Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use. This marks the fourth QIAstat-Dx syndromic test to receive US regulatory clearance in 2024.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. Many U.S. healthcare facilities still rely solely on traditional microbiological testing, which often requires samples to be incubated for at least 24 hours compared to QIAstat-Dx delivering results in about one hour. Traditional methods also lack sensitivity, which is critical given that only a small amount of cerebrospinal fluid (CSF) is collected from a patient for testing.

The QIAstat-Dx Meningitis/Encephalitis Panel leverages the system’s ability to quickly amplify many genetic targets at the same time using real-time PCR technology. The QIAstat-Dx panel simultaneously analyzes several of the most common viral, bacterial and fungal pathogens responsible for community-acquired meningitis/encephalitis.

The QIAstat-Dx system is also unique in that results include cycle threshold (Ct) values and amplification curves, which offer immediately viewable information for detected pathogens and provide healthcare professionals with additional clinical information not available with end-point PCR or other techniques.

All QIAstat-Dx panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx instrument. All reagents are preloaded into the cartridge, enabling the test set-up to be completed in less than a minute and requires no precision pipetting. Software interprets signals from the reaction and provides positive or negative results for each pathogen, providing clinicians with one of the simplest workflows for syndromic testing on the market.

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