The U.S. Food and Drug Administration (FDA) has cleared Qiagen's respiratory mini-panel, which is designed to aid in the diagnosis of five respiratory pathogens, for clinical use.
The QIAstat-Dx Respiratory Panel Mini is indicated for use in outpatient settings for the diagnosis of five common viral causes of upper respiratory infections: influenza A, influenza B, human rhinovirus, respiratory syncytial virus, and SARS-CoV-2. The panel multiplies many genetic targets using real-time polymerase chain reaction technology in the same reaction with about a minute of hands-on time, delivering results in about an hour, according to the company.
The QIAstat-Dx Respiratory Panel Mini is the second Qiagen respiratory panel to receive FDA clearance this year; in May, the QIAstat-Dx Respiratory Panel Plus received clearance. The QIAstat-Dx Respiratory Panel Plus covers 21 viral and bacterial targets.
Used together, Qiagen noted in its statement, the two FDA-cleared assays can address challenges that clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings, allowing clinicians to choose from a more comprehensive rapid test and a more targeted one depending on need.
