MDx-Chex® for BC-GP and BC-GN, new full-process, molecular diagnostics quality controls for bloodstream infections, receive FDA clearance

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.”