Controls for Sepsis Molecular Tests
Streck MDx-Chex™ for BCID2 is a first-of-its-kind quality control designed to meet the standards for verifying the performance of the BIOFIRE® Blood Culture Identification 2 Panel for sepsis.
It provides confidence in instrument results to ensure the best patient treatment decisions.
Applications
Evaluate the Entire Analytical Process of the BCID2 Panel Assay for Sepsis
Early identification and targeted treatment of sepsis are essential to minimise mortality rates from this all too common syndrome.
The BIOFIRE® Blood Culture Identification 2 (BCID2) Panel rapidly detects pathogens and antimicrobial resistance genes, directly from positive blood cultures, to shorten the time to optimal therapy.
To monitor accuracy and precision of the whole system the new Streck MDx-Chex™ Quality Control is specifically designed to meet the standards for verifying the entire analytical process of the BCID2 sepsis assay.
It evaluates the entire analytical process, including cell lysis, DNA extraction, purification and removal of PCR inhibitors, as well as qPCR amplification, detection and analysis.
MDx-Chex™ for BCID2 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.
Benefits
Challenges and verifies the entire analytical process of MDx-based sepsis assays
Cell lysis
DNA extraction/purification
PCR inhibition
Detection analysis
Results reporting
Saves the use of expensive sample-to-result cartridges
Use 2 cartridges Vs 6 cartridges
Provides complete target coverage
Easy to use
Pipette like a patient sample from a blood culture bottle
No pooling of individual microorganisms needed
Reduces preanalytical variables
Pipetting errors
Cross-contamination
Additional Information
MDx-Chex for BCID2 is a patient-like full process control designed to validate the entire analytical process for sample-to-result tests. The control kit contains 43 bacteria, yeasts and antimicrobial resistance gene targets packaged in two separate vials, one for Gram (-) bacteria and one for the Gram (+) bacteria and yeasts, covering targets commonly tested for in molecular sepsis tests. The microorganisms are intact, inactivated and suspended in a matrix of stabilised red blood cells, white blood cells and blood culture media components, which is designed to challenge the lysis and purification processes just like a patient sample.
MDx-Chex for BCID2 is a patient-like full process control designed to validate the entire analytical process for sample-to-result tests. The control kit contains 43 bacteria, yeasts and antimicrobial resistance gene targets packaged in two separate vials, one for Gram (-) bacteria and one for the Gram (+) bacteria and yeasts, covering targets commonly tested for in molecular sepsis tests. The microorganisms are intact, inactivated and suspended in a matrix of stabilised red blood cells, white blood cells and blood culture media components, which is designed to challenge the lysis and purification processes just like a patient sample.
MDx-Chex for BCID2 is mixed and pipetted like a positive patient blood culture bottle specimen. Pooling of microorganisms and “spike ins” of DNA are not needed, reducing the risk of cross-contamination, pipetting errors or other pre-analytical variables that may cause incorrect results.
A comprehensive, sample-to-result test requires a comprehensive control to validate the entire analytical process. MDx-Chex for BCID2 is such a control.
Comprised of inactivated microorganisms in a matrix of blood cells and culture media components to simulate a patient sample
Two sample-to-result tests needed for complete coverage of all 43 targets, which are contained in two vials
Allows for direct use on the sample-to-result test platform
Video
A step-by-step instruction for using MDx-Chex Quality Control for BCID2
with the BIOFIRE FilmArray® 2.0 and Torch Systems.
