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

Streck, a member of Bio Nebraska, has been granted FDA clearance for its blood stream infection and sepsis tests for use in diagnostic procedures.

Announcement from Streck

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.