The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision making in diagnosing upper respiratory infections in outpatient settings and covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.
The QIAstat-Dx Respiratory Panel Mini is the second QIAstat-Dx respiratory panel to receive FDA clearance this year. While the comprehensive 21-target QIAstat-Dx Respiratory Panel Plus is highly suitable for hospitalized patients with risk factors for severe disease, the more targeted QIAstat-Dx Respiratory Panel Mini offers a streamlined approach for diagnosing the five most actionable pathogens causing upper respiratory infections. This makes it an invaluable tool in outpatient settings, where its efficiency can benefit the widest possible patient population. The two FDA-cleared tests together effectively tackle the unique challenges that clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings.
“The QIAstat-Dx Respiratory Panel Mini and QIAstat-Dx Respiratory Panel Plus will improve diagnostic stewardship by enabling clinicians to tailor testing to each patient’s unique needs, choosing between a full, comprehensive panel or a more targeted one,” said Nadia Aelbrecht, Vice President and Head of the Syndromic Testing Franchise at QIAGEN. “By streamlining the diagnostic process and delivering accurate results in about an hour for both outpatient and inpatient groups, these tests will enhance patient care, promote responsible antimicrobial stewardship and alleviate the strain on healthcare systems.”
Respiratory tract infections are the leading cause of emergency department visits and hospitalizations. The CDC estimates that up to 41 million cases of influenza occur each year in the U.S., leading to several hundred thousand hospitalizations and up to 51,000 deaths.[1]
Syndromic tests like QIAstat-Dx have been shown to improve the detection of infections, including those involving multiple pathogens, reducing the need for additional testing. By providing fast results, syndromic testing enables healthcare providers to make informed treatment decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.
QIAGEN is expanding its portfolio for QIAstat-Dx in North America, with the recent launch of the QIAstat-Dx Analyzer 2.0, FDA clearance of the Gastrointestinal Panel 2 and submission for FDA clearance of the Meningitis/Encephalitis Panel. Submission for FDA clearance of the Gastrointestinal Panel Mini is planned before the end of this year.
After its launch in Europe in spring 2024, the QIAstat-Dx Analyzer 2.0 is now also available in the U.S. for use with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Gastrointestinal Panel 2. An extension for use with the QIAstat-Dx Respiratory Panel Mini is already planned. The upgraded diagnostic system introduces the Remote Results Application, a unique feature in the syndromic testing space. It allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location, facilitating seamless collaboration across the healthcare system.
The QIAstat-Dx Rise higher‑capacity version provides comprehensive testing for up to 160 tests per day using eight Analytical Modules instead of four. It is available with CE-IVD marking in Europe as well as other countries that accept this marking and is planned for submission to the FDA in 2025. [2] QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with more than 4,000 instruments placed worldwide.
More information on the QIAstat-Dx portfolio can be found here
