The panel identifies 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in approximately one hour.
QIAGEN received US Food and Drug Administration (FDA) clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, marking the company’s entry into the US bloodstream infection testing market.
The panel detects 20 gram-positive bacterial and fungal pathogen targets, a pan gram-negative target, and 10 genetic antimicrobial resistance markers from positive blood culture samples. The system is designed to provide results in about one hour, which can support clinical treatment decisions, antimicrobial stewardship, and infection prevention measures, according to a press release from QIAGEN.
Bloodstream infections are associated with high morbidity and mortality and can progress to sepsis, a life-threatening condition. An estimated 1.7 million adults in the US develop sepsis annually, highlighting the need for rapid diagnostic information in clinical settings.
“Every hour, even minutes, count with bloodstream infections,” says Nitin Sood, senior vice president and head of product portfolio and innovation at QIAGEN, in a release. “This clearance gives US laboratories a fast and integrated way to identify pathogens and key genetic antimicrobial resistance markers, supporting more informed treatment decisions and responsible antibiotic use.”
The QIAstat-Dx system integrates sample preparation, multiplex PCR testing, and data analysis into a single workflow. The platform is designed to provide easy-to-interpret results while reducing hands-on time for laboratory professionals.
This clearance expands the QIAstat-Dx menu in the US to four major infectious disease areas: respiratory, gastrointestinal, central nervous system, and bloodstream infections. The FDA clearance also establishes the first member of a planned family of bloodstream infection panels for the platform, according to a release from the company. A complementary panel designed to detect gram-negative pathogens and associated genetic antimicrobial resistance markers is currently under FDA review.
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