FDA clears Streck’s MDx quality control for BioFire sepsis product

Jan. 31, 2022

Streck said its quality control kit for the BioFire BCID2 Panel for sepsis has been granted clearance by the U.S. Food and Drug Administration (FDA).

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 at Streck.

Established in 1971, Streck develops and manufactures products in hematology, immunology, molecular diagnostics, cell stabilization, infectious diseases, and urinalysis for clinical and research laboratories.

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