Sept. 26, 2023—Streck announced that its 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.
MDx-Chex evaluates the analytical process of the Verigene BC-PG and BC-GN tests, including cell lysis, DNA extraction, and DNA hybridization, detection, and analysis. MDx-Chex molecular controls 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. 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 and can be run in the same manner as patient samples.