One-Hour Molecular Panel Expands Bloodstream Infection Testing for Gram-Negative Pathogens

Bloodstream infections can progress rapidly and lead to sepsis, organ failure, and death. In the United States, about 1.7 million adults develop sepsis each year, and at least 350,000 die during hospitalization or are discharged to hospice. Because treatment decisions are time-sensitive, rapid identification of pathogens and resistance markers is critical. 

QIAGEN’s QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance (AMR) markers. The assay reports results in about one hour and is designed to complement the existing gram-positive and fungal coverage within the same portfolio. Together, the two panels establish a comprehensive approach to bloodstream infection detection on a single platform. 

Image: The clearance also broadens QIAstat-Dx\'s infectious disease testing menu in the U.S., which already includes panels for respiratory and gastrointestinal infections, as well as meningitis and encephalitis (Photo courtesy of Qiagen)

The panel runs on the QIAstat-Dx system, which integrates sample preparation, multiplex PCR, and data analysis in a single automated workflow. This end-to-end design aims to streamline laboratory operations by consolidating steps from extraction to interpretation. The common instrument allows laboratories to use both panels without changing platforms.

In the United States, the QIAstat-Dx BCID GN Plus AMR Panel has received clearance from the Food and Drug Administration (FDA). The assay complements the recently FDA-cleared QIAstat-Dx BCID GPF Plus AMR Panel for gram-positive bacteria and fungi. Together, the two panels cover 33 pathogen targets and 28 antimicrobial resistance (AMR) markers, with results available in about one hour. 

The latest clearance gives U.S. laboratories access to the complete QIAstat-Dx bloodstream infection testing portfolio while further expanding the system’s infectious disease testing menu in the United States.

“Bloodstream infections demand fast answers. With both panels now cleared in the U.S., laboratories can identify a broad range of pathogens and antibiotic resistance markers on the same QIAstat-Dx system. This can provide clinicians with timely information to support treatment decisions and address antibiotic resistance,” said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN.