Blood Culture Assay Enhances Diagnostic Stewardship Through Targeted Panel Selection

Each year, around 250,000 individuals in the US are diagnosed with bloodstream infections (BSIs). Sepsis caused by these infections carries a mortality rate ranging from 16% to 40%, and any delay in administering appropriate treatment further heightens patient risk. Sepsis is also the most costly reason for hospitalization in the US, with expenses exceeding USD 20 billion annually. When a bloodstream infection is suspected, laboratories begin by performing cultures and Gram staining. Based on the Gram stain findings, which identify the pathogen type, such as yeasts, gram-positive, or gram-negative bacteria, the lab can then select the most suitable molecular test panel. This targeted testing method helps reduce overall costs compared to broader approaches that test for a wide array of pathogens regardless of Gram stain results. Now, a new assay designed specifically for gram-positive pathogens offers clinicians the ability to improve diagnostic stewardship by enabling more precise and cost-effective panel selection.

Diasorin’s (Saluggia VC, Italy) LIAISON PLEX® Gram-Positive Blood Culture Assay detects 17 targets (13 gram-positive bacteria and 4 relevant resistance gene targets) in under 2 hours, including Bacillus spp. and mecC, in addition to the targets currently found on the VERIGENE® Gram-Positive Blood Culture Test, providing clinicians with the ability to make rapid and targeted treatment decisions. The assay features Diasorin’s proprietary NanoGrid technology, which allows the detection of nucleic acids without the need for conventional amplification reactions, thereby minimizing the risk of false positives.

Image: The LIAISON PLEX® Gram-Positive Blood Culture Assay runs on the on the LIAISON PLEX instrument (Photo courtesy of Diasorin)

Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Positive Blood Culture Assay, the final syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the LIAISON PLEX®. Diasorin has now received 510(k) clearance from the FDA for both the respiratory and the blood culture portfolio on the LIAISON PLEX®.

“With this FDA clearance, we are now positioned to offer our expanding customer base a comprehensive and flexible menu of multiplex panels for the diagnosis of bloodstream infections on the LIAISON PLEX®,” said Angelo Rago, President of Luminex. “This milestone provides clinicians with unmatched flexibility to tailor blood culture panels based on individual patient needs. We are committed to continue expanding our offering on the platform to ensure broad access to our multiplexing solutions that deliver fast, accurate, and cost-effective results, ultimately supporting improved patient outcomes.”