QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics
QIAGEN announced that the U.S. 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 U.S. regulatory clearance in 2024.
The QIAstat-Dx delivers results in about one hour. 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.
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.
