QIAGEN expands U.S. infectious disease testing with FDA-cleared bloodstream infection panel

QIAGEN has received FDA clearance for its new QIAstat-Dx bloodstream infection panel, enabling U.S. labs to rapidly detect gram-negative bacteria and resistance markers within an hour, expanding its infectious disease testing menu.

QIAGEN announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection portfolio following clearance of a new panel by the U.S. Food and Drug Administration (FDA).

The new panel detects gram-negative bacteria and antibiotic resistance markers in about one hour, complementing the recently FDA-cleared QIAstat-Dx panel for gram-positive bacteria and fungi.

The new QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers. It complements the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel, which identifies gram-positive bacteria and fungi.

Together, the two panels cover 33 pathogen targets and 28 antimicrobial resistance markers. The gram-negative panel covers 13 pathogen targets and 18 resistance markers, while the gram-positive and fungal panel covers 20 pathogen targets and 10 resistance markers. Both deliver results in about one hour.

The clearance also expands the QIAstat-Dx infectious disease testing menu in the U.S., which already includes tests for respiratory and gastrointestinal infections, as well as for meningitis and encephalitis.

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