QIAGEN announced that the U.S. Food and Drug Administration (FDA) has granted expanded clearance for use of the FecalSwab sample type across all QIAstat-Dx Gastrointestinal Panels, enabling full pathogen detection including STEC and EPEC.
The QIAstat-Dx Gastrointestinal Panel 2 can detect up to 16 clinically relevant pathogens for use in high-risk patients, while the QIAstat-Dx GI Panel 2 Mini B and QIAstat-Dx GI Panel 2 Mini B&V provide focused detection of up to five pathogens depending on testing needs. All three panels now fully integrate use of the FecalSwab sample type for both broad and targeted testing, making QIAstat-Dx the first fully FDA-cleared GI Panel with more than five targets with the FecalSwab sample type.
The latest FDA clearance adds Shiga toxin-producing E. coli (STEC) and Enteropathogenic E. coli (EPEC) to the list of pathogens that can be reported when testing by FecalSwab collected from stool samples with the QIAstat-Dx Gastrointestinal Panel 2, including detection of clinically relevant STEC subtypes such as stx2f. Likewise, STEC can now be reported as well for both the QIAstat-Dx GI Panel 2 Mini B and QIAstat-Dx GI Panel 2 Mini B&V.
The FecalSwab sample type offers practical advantages in sample collection, transport and storage compared to traditional stool collection. With this clearance, U.S. laboratories can test unpreserved stool specimens using either Para-Pak C&S stool transport medium or FecalSwab transport medium without compromising the ability to detect and report high-priority pathogens.
This flexibility supports a wide range of clinical workflows, including inpatient, outpatient, and emergency settings.
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