With the release of Lot #3359 on November 29, 2023, MDx-Chex for BCID2 will be configured into single-use vial format and a 12-month expiration date.

MDx-Chex^® for BCID2

MDx-Chex for BCID2 is a first-of-its-kind quality control designed to evaluate the entire analytical process of the BIOFIRE^® Blood Culture Identification 2 (BCID2) Panel for sepsis. With MDx-Chex for BCID2, you can track lot-to-lot performance of the BCID2 assay and reduce the occurrence of incorrect results due to instrument or assay failures.

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Product Description

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 (-) bacteria and 5 for Gram (+) bacteria and yeasts…

For In Vitro Diagnostics Use.

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 BIOFIRE FilmArray^® Torch and 2.0 platforms
Provides complete coverage of all 43 BIOFIRE BCID2 Panel targets

Benefits

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

Benefits of MDx-Chex controls 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•	Yes	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 BIOFIRE BCID2 Panel
** 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

5 Gram (–) bacteria and 5 Gram (+) bacteria vials, 5 run capacity	250065

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Resources

Instructions (IFU)

Assays

Certificates

SDS

Product Information

Resources

A step-by-step instruction for using MDx-Chex for BCID2 with the BIOFIRE FilmArray^® 2.0 and Torch Systems.

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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