Streck’s first-of-its-kind molecular diagnostics quality control MDx-Chex for BCID2 receives FDA clearance
La Vista, NE –Streck is pleased to announce MDx-Chex™ for BCID2, a first-of-its-kind quality control designed to meet the standards for verifying the performance of the BioFire® BCID2 Panel for sepsis, has been granted FDA clearance for In Vitro Diagnostics Use.
MDx-Chex for BCID2 is a patient-like full process control designed to validate each sample processing step included in the pouch for BioFire’s BCID2 Panel. The control kit contains 43 bacteria, yeasts and antimicrobial resistance gene targets packaged in two separate vials, one for Gram (-) bacteria and one for the Gram (+) bacteria and yeasts, detected by the BioFire BCID2 assay. The microorganisms are intact, inactivated and suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, which is designed to challenge the lysis and purification processes like a patient sample.
“The FDA clearance for Streck’s MDx-Chex for BCID2 will provide additional confidence for our customers in their assay results and will soon be the gold standard control for blood sepsis diagnostic tests,” said Matthew Kreifels, Vice President of Sales and Business Development.
“We are pleased to see the control receive FDA clearance,” said Chris Connelly, Ph.D., Director of R&D. “It substantiates the performance of MDx-Chex for BCID2 as a quality control for BioFire’s Blood Culture Identification 2 panel on FilmArray® Torch and 2.0 systems. This is a great product to see paired with a market leading molecular diagnostic test for sepsis.
“It is crucial for labs to have access to controls that verify all sample processing steps needed for nucleic acid amplification tests and instrumentation,” Connelly said. “Currently, there is no other control like this available to the market.”
About Streck, Inc.
Established in 1971, Streck develops and manufactures products in hematology, immunology, molecular diagnostics, cell stabilization, infectious diseases, and urinalysis for clinical and research laboratories. Streck’s passion for innovation, quality and service are what makes the organization a world leader in the development of quality control and diagnostic products helping laboratories ensure accurate and timely results for patients.