MDx-Chex® for BC-GP and BC-GN, new full-process, molecular diagnostics quality controls for bloodstream infections, receive FDA clearance
La Vista, Nebraska – Streck is pleased to announce that MDx-Chex® for BC-GP and MDx-Chex® for BC-GN, quality controls designed to verify the performance of the Luminex® VERIGENE® Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for blood stream infection and sepsis, have been granted FDA clearance for use in diagnostic procedures.
Provided in a comprehensive and easy-to-use format, MDx-Chex evaluates the entire analytical process of the Luminex VERIGENE tests, including cell lysis and DNA extraction, as well as DNA hybridization, detection and analysis. MDx-Chex 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 BC-GP and MDx-Chex for BC-GN cover all targets tested with Luminex VERIGENE BC-GP and BC-GN within a single positive control tube, respectively. Because each control contains intact, inactivated microorganisms that are suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, they can be run in the same manner as patient samples, reducing the risk of pre-analytical variables that may cause incorrect results.
“Streck has received FDA clearance for our new molecular diagnostics controls, MDx-Chex for BC-GP and BC-GN,” said Matthew Kreifels, Vice President of Sales, MarCom, and Business Development. “This will provide additional confidence for our customers in their assay results and joins our MDx-Chex for BCID2 controls as the gold standard control for blood-based diagnostic tests for sepsis.”
“We are pleased to see each of these control kits receive FDA clearance,” said Chris Connelly, Ph.D., Director of R&D. “It further substantiates the quality and performance of MDx-Chex products, now with the addition of quality controls for BC-GP and BC-GN panels on the Luminex VERIGENE system. 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-based tests and instrumentation. Currently, there are no other controls like this available to the market.”
For more information, please visit streck.com.
About Streck, Inc.
Established in 1971, Streck develops and manufactures products in hematology, immunology, microbiology, molecular diagnostics and cell stabilization for clinical and research laboratories. Streck’s passion for innovation, quality and service makes the organization a world leader in the development of quality control and diagnostic products, helping laboratories ensure accurate and timely results for patients.