Streck has received U.S. Food and Drug Administration (FDA) clearance of three MDx-Chex controls for sepsis testing as in vitro diagnostics (IVD), according to an announcement.
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.
MDx-Chex for BCY, MDx-Chex for BCP and MDx-Chex for BCN give 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.
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.
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