NEW YORK – Streck announced on Friday that it has received clearance from the US Food and Drug Administration for a quality control material, called MDx-Chex for BCID2, to verify the performance of the BioMérieux BioFire Blood Culture Identification 2 panel for sepsis.
The Streck MDx-Chex for BCID2 contains 43 bacteria, yeasts, and antimicrobial resistance gene targets packaged in separate vials for Gram-negative and Gram-positive species.
The firm said in a statement that it is a "patient-like" full process control designed to validate each sample processing step included in the pouch for the BCID2 panel and can be used to QC the panel on FilmArray Torch and 2.0 systems.
The microorganisms in the MDx-Chex for BCID2 are "intact, inactivated, and suspended in a matrix of stabilized red blood cells, white blood cells, and blood culture media components," Streck said. In this way, it is designed to "challenge the lysis and purification processes" in a similar way as a patient sample would.
Streck's director of R&D, Chris Connelly, noted that it is crucial for labs to have access to controls that verify all sample processing steps needed for nucleic acid amplification tests and instrumentation. "Currently, there is no other control like this available to the market," he said.
Matthew Kreifels, VP of sales and business development for La Vista, Nebraska-based Streck said that FDA clearance "will provide additional confidence for our customers in their assay results."