La Vista, Nebraska – Streck is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of three MDx-Chex® controls for sepsis testing as in vitro diagnostics (IVD). MDx-Chex for BCY, MDx-Chex for BCP and MDx-Chex for BCN are true patient-like, ready-to-use, full-process molecular quality controls designed for verification of the DiaSorin LIAISON PLEX® Yeast, Gram-Positive and Gram-Negative Blood Culture Assays, respectively.  

Sepsis affects more than 1.7 million adults in the United States each year and demands rapid, accurate identification of causative pathogens and resistance genes to guide targeted therapy. MDx-Chex for BCY, MDx-Chex for BCP and MDx-Chex for BCN address that need by giving laboratories a reliable way to verify their sepsis testing workflow — from lysis and extraction through detection — using intact, inactivated microorganisms suspended in a stabilized, patient-like matrix.  

“Sepsis diagnostics demand both speed and accuracy, and the laboratories running these panels carry an enormous responsibility,” said Chris Connelly, Director of Business Segment – Molecular at Streck. “MDx-Chex for BCY, MDx-Chex for BCP and MDx-Chex for BCN give labs running LIAISON PLEX Blood Culture Assays the confidence that their entire workflow is validated and performing correctly. That confidence translates directly to better patient care.” 

The LIAISON PLEX platform is a fully automated, random-access multiplex PCR system enabling simultaneous detection of a broad range of pathogens and resistance genes from a single blood culture sample. MDx-Chex for BCY, MDx-Chex for BCP and MDx-Chex for BCN are cleared specifically for the Yeast, Gram-Positive and Gram-Negative Blood Culture Assays, respectively, on this platform, providing an end-to-end quality assurance solution that mirrors real patient sample processing. 

Supplied in 10 single-use vial kits (Cat. No’s 250083, 250084, 250085) and stored at room temperature, the controls cover the clinically relevant gram-positive and gram-negative bacteria, fungi and antimicrobial resistance (AMR) markers specifically targeted by the LIAISON PLEX Blood Culture Assays. 

About Streck LLC. Established in 1971, Streck provides solutions that ensure every result counts by empowering clinical and research laboratories to reliably deliver accurate results, advance diagnostics and enable healthier, happier lives for patients everywhere. Streck products are manufactured in La Vista, Nebraska, and delivered to thousands of labs worldwide.