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MDx-Chex for BCID2 is a patient-like full process control designed to validate the entire analytical process of the BIOFIRE® BCID2 Panel, including cell lysis, DNA extraction, purification and removal of PCR inhibitors in addition to qPCR amplification, detection and analysis.
MDx-Chex for BCID2 covers all targets tested on the BIOFIRE BCID2 Panel: 43 bacteria, yeasts and antimicrobial resistance gene targets packaged in 10 single-use vials, 5 for gram-positive bacteria and 5 for gram-negative bacteria and yeasts.
Microorganisms are intact, inactivated and suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, providing you with a control that can be mixed and pipetted like a positive patient sample, reducing the risk of cross-contamination, pipetting errors or other preanalytical variables that may cause incorrect results.
For In Vitro Diagnostics Use.
Patient-like matrix of inactivated microorganisms, blood cells and culture media components
Can be directly used on the BIOFIRE FilmArray® Torch and 2.0 platforms
Provides complete coverage of all 43 BIOFIRE BCID2 Panel targets
Challenges and verifies the entire analytical process of the BIOFIRE BCID2 Panel
Single-use vials reduce preanalytical variables such as pipetting errors and cross-contamination
Easy to use – simply pipette like a patient sample
| Description | Item Number |
|---|---|
| 5 tubes gram negative bacteria, 5 tubes gram positive bacteria plus yeast | 250065 |
MDx-Chex for BCID2 is a quality control material specifically designed for the BIOFIRE BCID2 Panel (Blood Culture Identification 2). It contains intact, inactivated microorganisms suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, allowing it to behave like a positive patient blood culture sample for accurate quality control testing.
MDx-Chex for BCID2 is designed to control for the complete panel of gram-positive bacteria, gram-negative bacteria, yeast and antimicrobial resistance markers detected by the BIOFIRE BCID2 Panel. For a complete list of controlled organisms and resistance genes, please refer to the Instructions For Use.
Unlike traditional quality control materials, MDx-Chex for BCID2 can be mixed and pipetted like an actual positive patient sample, which minimizes the risk of cross-contamination, pipetting errors and other preanalytical variables. The inactivated microorganisms are suspended in a clinically relevant matrix that mimics real blood culture samples, ensuring consistent handling and reducing workflow disruptions.
No, MDx-Chex for BCID2 can be stored at room temperature (15-30°C), which simplifies storage requirements and provides greater flexibility in laboratory inventory management. 5. Can MDx-Chex for BCID2 used directly on BIOFIRE systems?
Yes, MDx-Chex for BCID2 can be used on the BIOFIRE FilmArray Torch and 2.0 systems just like a patient sample. The controls reduce preanalytical variables such as pipetting errors and cross-contamination because they can be mixed and handled using the same workflow as actual patient blood culture samples.
Yes, MDx-Chex for BCID2 has FDA Class II clearance for use with the BIOFIRE BCID2 Panel. This clearance provides assurance of quality and performance for laboratories seeking regulatory compliance and accreditation.
Quality control frequency should follow your laboratory’s standard operating procedures and regulatory requirements (CLIA, CAP or other accreditation standards). Most laboratories run QC with each new lot of reagents, after instrument maintenance or calibration and at regular intervals (daily, weekly or per manufacturer recommendations) to ensure the BIOFIRE BCID2 Panel is performing accurately.
