The test identifies 13 bacterial targets and 18 antibiotic resistance markers in about one hour on the QIAstat-Dx system.
The US Food and Drug Administration (FDA) has cleared Qiagen‘s QIAstat-Dx BCID GN Plus AMR Panel, providing US clinical laboratories with access to the company’s full bloodstream infection testing menu.
The diagnostic test detects 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers in approximately one hour. It complements the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel, which tests for gram-positive bacteria and fungi.
Expanding Bloodstream Infection Testing
Bloodstream infections can escalate rapidly and trigger sepsis, a severe systemic reaction that can cause organ failure and death. According to the US Centers for Disease Control and Prevention, roughly 1.7 million US adults develop sepsis each year, and at least 350,000 die during hospitalization or are discharged to hospice. Rapid identification of causative pathogens helps clinical teams make targeted antimicrobial treatment decisions.
Together, the two complementary panels cover 33 pathogen targets and 28 antimicrobial resistance markers. The gram-negative panel targets 13 pathogens and 18 resistance markers, while the gram-positive and fungal panel covers 20 pathogen targets and 10 resistance markers, with both providing results in about one hour.
“Bloodstream infections demand fast answers,” says Nitin Sood, senior vice president and head of product portfolio and innovation at Qiagen, in a release. “With both panels now cleared in the US, 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.”
Automated Syndromic Workflow
The QIAstat-Dx system consolidates sample preparation, multiplex PCR testing, and data analysis into a single automated workflow. The platform is available in more than 100 countries and had surpassed 5,200 cumulative placements by the end of 2025.
The addition of the gram-negative panel also expands the QIAstat-Dx infectious disease menu in the US, which currently includes cleared panels for respiratory infections, gastrointestinal infections, and meningitis and encephalitis.
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