ResourceGeneral Lab

MDx-Chex controls for molecular-based testing

16 May 2024

The FDA-cleared, class II assayed, patient-like full process controls, MDx-Chex™, contain intact, inactivated microorganisms suspended in a matrix of blood culture media components. The controls aim to address the gap in coverage left by traditional quality controls and ensure reliable and accurate sepsis testing. Streck discusses the development of MDx-Chex controls for use in automated DNA-based sepsis tests, and highlights data on the precision and reproducibility of these controls across multiple sites and systems. Overall, MDx-Chex controls provide a more comprehensive measure of assay performance than traditional controls and help maintain assay quality and compliance with accrediting standards and guidelines.