By IDSE News Staff

The FDA cleared the QIAstat-Dx Meningitis/Encephalitis Panel (Qiagen) for clinical use.

Many U.S. healthcare facilities rely solely on traditional microbiological testing with results taking 24 hours or more, compared with 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 is collected from a patient for testing.

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

The QIAstat-Dx system also includes cycle threshold 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.

“Community-acquired meningitis and encephalitis can progress rapidly, and that means healthcare providers need evidence-based diagnostics that can help them make rapid treatment decisions. The QIAstat-Dx Meningitis/Encephalitis Panel addresses many challenges faced by clinicians and streamlines the process so they can get timely and accurate results in about one hour,” said Fernando Beils, the senior vice president and head of the Molecular Diagnostics Business Area, Qiagen. 

Of note, 1 in 5 cases of bacterial meningitis results in permanent complications such as hearing loss, brain damage and seizures. Without prompt treatment, about 50% of patients die, according to the WHO (https://www.who.int/news-room/fact-sheets/detail/meningitis). 

Bacterial meningitis cases in the United States have reached their highest levels since 2014, with case numbers varying from state to state depending on vaccination rates, according to the CDC. 

This new system marks the fourth FDA clearance of a QIAstat-Dx panel in 2024. Other recent FDA clearances are:

  • QIAstat-Dx Gastrointestinal Panel 2
  • QIAstat-Dx Respiratory Panel Plus
  • QIAstat-Dx Respiratory Panel Mini

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 setup to be completed in less than one 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.
More information can be found at http://www.qiagen.com.