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Streck Quality Controls for DiaSorin's Luminex Sepsis Tests Receive FDA Clearance

NEW YORK – Streck announced on Monday that its MDx-Chex quality controls have received clearance from the US Food and Drug Administration. 

The quality controls are designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive and Gram-Negative tests for bloodstream infection and sepsis, Streck said in a statement. They evaluate the entire analytical process of the DiaSorin subsidiary's tests, including cell lysis, DNA extraction, and DNA hybridization, detection, and analysis. Each control contains intact, inactivated microorganisms suspended in a matrix of stabilized red blood cells, white blood cells, and blood culture media components, Streck said.

The MDx-Chex controls can be used for assay verification, to track lot-to-lot performance of tests, and to reduce the occurrence of incorrect results because of instrument or test failures, Streck noted. 

The FDA clearance "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," Chris Connelly, director of R&D for Streck, said in a statement. "It is crucial for labs to have access to controls that verify all sample processing steps needed for nucleic acid-based tests and instrumentation."