BIOFIRE has updated their list of Quality Control Materials for use with FilmArray Panels. MDx-Chex for BCID2 has been added to the list of QC material appropriate for use with the BCID2 Panel.
MDx-Chex™ for BCID2
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 (BCID2) Panel for sepsis. Provided in a comprehensive and easy-to-use format, MDx-Chex for BCID2 evaluates the entire analytical process of the assay, 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 the BCID2 assay and to reduce the occurrence of incorrect results due to instrument or assay failures.
MDx-Chex for BCID2 is a patient-like full process control designed to validate the entire analytical process of the BIOFIRE BCID2 Panel. 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 tested on the BIOFIRE BCID2 Panel. The microorganisms are intact, inactivated and suspended in a matrix of stabilized 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.
For In Vitro Diagnostics Use.
A step-by-step instruction for using MDx-Chex for BCID2 with the BIOFIRE FilmArray® 2.0 and Torch Systems.
- Comprised of inactivated microorganisms in a matrix of blood cells and culture media components to simulate a patient sample.
- Two BIOFIRE BCID2 pouches needed for complete coverage of all 43 targets, which are contained in two vials.
- Allows for direct use on the BIOFIRE FilmArray Torch and 2.0 platforms.
- Challenges and verifies the entire analytical process of the BIOFIRE BCID2 Panel assay.
- Cell lysis
- DNA extraction/purification
- PCR inhibition
- Detection analysis
- Results reporting
- Saves the use of expensive BIOFIRE BCID2 Panel pouches.
- Use 2 pouches vs. 6 pouches, as needed with some competitor controls.
- 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
|1 Gram (–) bacteria and 1 Gram (+) bacteria vial, 5 run capacity||250065|
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Molecular Diagnostics (MDx) are the tests and techniques that have been developed in recent decades that analyze biological markers such as nucleic acids and proteins, to diagnose and monitor disease, detect disease risks and to monitor the effectiveness of treatments. MDx assays are used in prenatal testing, infectious disease testing, cancer and inherited diseases testing.
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