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

Streck
4 Oct 2023
Jemima Arnold
Editorial Assistant

Industry news

Streck has recently announced 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.

MDx-Chex evaluates the 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 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.

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.SepsisSepsis is a life-threatening response to infection causing organ dysfunction. Research focuses on early detection, biomarkers, and therapies to reduce mortality. Explore tools for sepsis diagnostics and analysis in our peer-reviewed product directory, including detection kits and biomarkers.Blood AnalysisThe analysis of blood is vital for many areas of life sciences and forensic investigations. Blood samples can be tested for a number of different reasons such as diagnosis, glucose levels, cholesterol and drug testing.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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