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.

MDx-Chex for BCID2 vials

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…

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Mdx-Chex for BCID2 package and vial

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.

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

DescriptionCatalog Number
 
5 Gram (–) bacteria and 5 Gram (+) bacteria vials, 5 run capacity250065

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