Streck has announced the launch of MDx-Chex™ for BCID2, a first-of-its-kind quality control designed to meet the standards for verifying the performance of sample-to-result molecular tests for sepsis. MDx-Chex for BCID2 is For Research Use Only. Not for use in diagnostic procedures.
Provided in a comprehensive and easy-to-use format, MDx-Chex for BCID2 evaluates the entire analytical process of the molecular sepsis test, including cell lysis, DNA extraction, purification and removal of PCR inhibitors, as well as qPCR amplification, detection and analysis. MDx-Chex for BCID2 can be used for assay verification, to track lot-to-lot performance of tests and to reduce the occurrence of incorrect results due to instrument or assay failures.
MDx-Chex for BCID2 is a patient-like full process control designed to validate the entire analytical process for sample-to-result tests. 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, covering targets commonly tested for in molecular sepsis tests. 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.
“We are extremely excited to leverage Streck’s expertise in the design, development and manufacture of quality controls by introducing this control to the molecular testing space for sepsis,” said Chris Connelly, Ph.D., Director of R&D. “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.”
“Streck is pleased to provide MDx-Chex for BCID2 as its first product in its molecular controls portfolio,” said Matthew Kreifels, Vice President of Sales and Business Development. “Streck has integrated stabilized biological targets into its blood products for more than 50 years. We are very excited to bring our quality control expertise and knowledge to the molecular space for sepsis, a serious, complex and life-threatening infection.”
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