MDx-Chex^® for BC-GP and MDx-Chex^® for BC-GN

MDx-Chex for BC-GP and BC-GN are controls designed to evaluate the entire analytical process of the Luminex VERIGENE^® BC-GP and BC-GN Panels for sepsis. With MDx-Chex for BC-GP and BC-GN, you can track lot-to-lot performance of the BC-GP and BC-GN assays and reduce the occurrence of incorrect results due to instrument or assay failures.

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MDx-Chex for BC-GP and MDx-Chex for BC-GN

Product Description

MDx-Chex for BC-GP and BC-GN are patient-like full process controls designed to validate the entire analytical process of the Luminex VERIGENE BC-GP and BC-GN Panels, including automated nucleic acid extraction, DNA purification, hybridization of target DNA to the microarray, hybridization of gold nanoparticles to target DNA and silver staining of hybridized probes. MDx-Chex for BC-GP and BC-GN cover all targets tested with Luminex VERIGENE for BC-GP or BC-GN, respectively. Microorganisms are intact, inactivated and…

Keep sepsis testing on target with MDx-Chex controls

Watch this video to learn how MDx-Chex controls comprehensively evaluate the performance of your BIOFIRE^® BCID2 and VERIGENE BC-GP and BC-GN sepsis tests.

Features

Patient-like matrix of inactivated microorganisms, blood cells and culture media components
Can be directly used on the Luminex VERIGENE system
Complete coverage of all BC-GP or BC-GN Panel targets in a single vial
Negative controls contain only blood cells and culture media components for a true patient-like negative control

Benefits

Challenges and verifies the entire analytical process of the Luminex VERIGENE assays
Reduces preanalytical variables such as pipetting errors and cross-contamination
Easy to use — simply pipette like a patient sample

Benefits of MDx-Chex for BC-GP and BC-GN over other available controls
	Streck	Competitor A	Competitor B
Preanalytical Variables
Sample tracking (via barcode)^	Yes	No	No
Controls technician sample handling	Yes	No	No+
Preanalytical Variables
Lysing
Contains non-infectious intact organisms	Yes	No	Yes
Contains human RBCs and WBCs	Yes	No	No
Lyses all panel organisms	Yes	No	Yes*
Nucleic Acid Isolation and Purification	Yes	No	No
Patient-like sample matrix	Yes	No	No
Inhibitors
RBCs (i.e., hemoglobin)	Yes	No	No
WBCs (i.e., interleukin, human genomic DNA)	Yes	No	No
Culture media chemicals	Yes	No	No
Specificity
All targets present	Yes	Yes**	Yes*
Off target (human gDNA) present	Yes	No	No
Detection
All DNA targets	Yes•	No	Yes*
FDA Class II Clearance	Yes	No	No

+ Requires pooling of multiple components, not part of patient sample testing workflow
* If all panel organisms are pooled
• Streck controls contain all DNA targets for the Luminex VERIGENE BC-GP and BC-GN Tests
** When Lyophilized pellets are rehydrated and pooled together
^ Barcode allows the control lot number, expiration date and level to be captured in the software

Ordering Information

Description	Item Number

MDx-Chex for BC-GP – 5 Positive control vials & 5 Negative control vials, 5 control events	250079
MDx-Chex for BC-GN – 5 Positive control vials & 5 Negative control vials, 5 control events	250080

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Resources

Instructions (IFU)

Assays

Certificates

SDS

Product Information

ESCMID 2024 Presentation:

Molecular diagnostic tests: Why do you QC? Let’s get real…

Looking for an older document? Click here for archived assays and certificates.

With full-process controls and antibiotic resistance kits, Streck has the products to help you streamline your molecular diagnostics testing, aid antibiotic stewardship and ensure positive patient outcomes.

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