Gastrointestinal External Quality Controls

Whole-workflow gastrointestinal IVD and RUO External Quality Controls for molecular and immunoassay diagnostics.

Your Trusted Source of Gastrointestinal External Quality Controls

The Gastrointestinal panel includes liquid and swab formulations of inactivated viral, bacterial, and parasite pathogens that are suitable for use with nucleic acid and antigen detection assays. The panel includes but is not limited to Cryptosporidium parvum, Giardia lamblia, Rotavirus, Clostridium difficile, Campylobacter, and Helicobacter pylori single-analyte and multiplex products.

Proudly Supporting Over 100+ Customers with Leading  Diagnostic Solutions 

Microbix approached us before the pandemic started, and the relationship developed so easily and quickly that we formalized our collaboration in 2020. Along with their excellent technical capabilities, they have successfully developed relationships with many diagnostics manufacturers around the world. We are pleased that our FLOQSwabs® are their exclusive choice for their growing line of swab formatted QAPs™.”

Gaetano Natale, Chief Commercial Officer.

Setting the Gold Standard for Infectious Disease Diagnostic Standards

Ready to use External Quality Controls

Microbix is the only supplier licensed to manufacture their External Quality Swab Controls on Copan’s FLOQSwabs®. These swabs are room-temperature stable and have a wide storage range of 2-30°C.

Global Diagnostics Compliance

Manufactured under the strictest requirements of ISO 13485:2016, Majority of Microbix’s IVD quality controls are CE marked, registered with the U.S. FDA, Australian TGA, U.K. and Health Canada establishment licensed.

Unique Quality Control Products

Microbix offers inactivated whole-genome parasite external quality controls, including Cryptosporidium parvum and Giardia lamblia. Multiplex and single-analyte liquid products are available. 

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    Frequently Asked Questions

    What specific pathogens are included in your Gastrointestinal Panel?

    The gastrointestinal External Quality Control panel includes but is not limited to Cryptosporidium parvum, Giardia lamblia, Rotavirus, Clostridium difficile, Campylobacter, and Helicobacter pylori single-analyte and multiplex products.

    Are your gastrointestinal External Quality Controls suitable for use in clinical diagnostics or for research purposes?

    Yes. Our IVD brand (REDx™) of GI molecular controls are unassayed controls that can be used for ongoing QC, clinical laboratory operations, benchmarking lab GI External quality control diagnostic testing performance, operatory training and competency, and end-to-end workflow evaluation. 

    Our Research Use Only (RUO) brand (PROCEEDx™) products are used for assay verification/validation, training, and R&D purposes. 

    What is the shelf life of your gastrointestinal antigen control products?

    The shelf life of our Gastrointestinal External quality control panel is 2 years from the manufacturing date. when the swabs are stored at 2-30°C and the liquids are stored at 2-8°C

    Single Analyte Products
    Product NameREDx™ (IVD) Catalogue NumberPROCEEDx™ (RUO) Catalogue Number Product Description
    Cryptosporidium parvum Positive RED-37-01*VP-37-01

    Microbix Cryptospordium parvum Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Cryptosporidium parvum suspended in a proprietary buffer. Microbix Cryptospordium parvum Positive External Quality Controls have verified performance with
    Meridian Bioscience ImmunoCard STAT® Crypto/Giardia Rapid Assay, BioFire® FilmArray® Gastrointestinal Panel, and more.
    Format: Vial; 0.5 mL
    Storage Conditions: 2-8°C
    Assay Compatibility: MDx, Immuno
    *Products are QC-released with immunoassays but are also compatible with molecular assays
    *REDx™ products are only for sale in Canada and the United States

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    Giardia lamblia Positive RED-38-01*VP-38-01

    Microbix Giardia lamblia Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Giardia lamblia suspended in a proprietary buffer. Microbix Giardia lamblia Positive External Quality Controls have verified performance with
    Meridian Bioscience ImmunoCard STAT® Crypto/Giardia Rapid Assay, BioFire® FilmArray® Gastrointestinal Panel, and more.
    Format: Vial: 0.5 mL
    Storage Conditions: 2-8°C
    Assay Compatibility: MDx, Immuno
    *Products are QC-released with immunoassays but are also compatible with molecular assays
    *REDx™ products are only for sale in Canada and the United States

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    Rotavirus Positive RED-35-01*VP-35-01

    Microbix Rotavirus Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Rotavirus suspended in a proprietary buffer. Microbix Rotavirus Positive External Quality Controls have verified performance with
    Meridian Bioscience™ Immunocard STAT® Rotavirus Assay, SA Scientific SAS™ Rota Test, Remel™ Xpect™ Rotavirus Control Assay, Fisher Healthcare™ Sure-Vue™ Rota Test assay, and more
    Format: Vial; 1.0 mL
    Storage Conditions: 2-8°C
    Assay Compatibility: MDx, Immuno
    *Products are QC-released with immunoassays but are also compatible with molecular assays
    *REDx™ products are only for sale in Canada and the United States

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    C.difficile GDH Positive Swab N/AVP-S-39-01

    Microbix C.difficile GDH Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with Glutamate Dehydrogenase (GDH) desiccated on a Copan FLOQSwab®. Microbix C.difficile GDH Positive Swab External Quality Controls have verified performance on various IVD assays, such as Quidel Sofia 2 C. difficile FIA and more.
    Format: Copan FLOQSwab®
    Storage Conditions: 2-30°C
    Assay Compatibility: Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    Campylobacter OMP Positive Swab N/AVP-S-40-01

    Microbix Campylobacter OMP Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with Camplylobater recombinant Outer Membrane Protein (OMP) desiccated on a Copan FLOQSwab®. Microbix Campylobacter OMP Positive Swab External Quality Controls have verified performance on various IVD assays, such as Quidel Sofia 2 Campylobacter FIA, and more.
    Format: Copan FLOQSwab®
    Storage Conditions: 2-30°C
    Assay Compatibility: Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    H. pylori Positive Swab Coming soon VP-S-27-01

    Microbix H. pylori Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated H. pylori stool antigen desiccated on a Copan FLOQSwab®. Microbix H. pylori Positive Swab External Quality Controls have verified performance on various IVD assays, such as CerTest H. Pylori test kit, and more.
    Format: Copan FLOQSwab®
    Storage Conditions: 2-30°C
    Assay Compatibility: Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    Multiple Analyte Products      
    Product NameREDx™ (IVD) Catalogue NumberPROCEEDx™ (RUO) Catalogue Number Product Description
    Cryptosporidium parvum + Giardia lamblia Positive RED-37-02*VP-37-02

    Microbix Cryptospordium parvum and Giardia lamblia Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Cryptosporidium parvum and Giardia lamblia suspended in a proprietary buffer. Microbix Cryptospordium parvum and Giardia lamblia Positive External Quality Controls have verified performance with
    Meridian Bioscience™ Immunocard STAT® Crypto/Giardia Rapid Assay, Fisher Healthcare™ Sure-Vue™ Signature Test Kit Assay – Cryptosporidium/Giardia, and more.
    Format: Vial; 0.5 mL
    Storage Conditions: 2-8°C
    Assay Compatibility: MDx, Immuno
    *Products are QC-released with immunoassays but are also compatible with molecular assays
    *REDx™ products are only for sale in Canada and the United States

    Click here to view Microbix QAPs™ Gastrointestinal brochure

    C.difficile GDH/Toxin A/ Toxin B Positive Swab N/A VP-S-39-02 Microbix C.difficile GDH/Toxin A/Toxin B Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with Glutamate Dehydrogenase (GDH),Toxin A and Toxin B desiccated on a Copan FLOQSwab®. Microbix C.difficile GDH/Toxin A/ToxinB Positive Swab External Quality Controls have verified performance on various IVD assays, such as Quidel Sofia 2 C. difficile FIA, and more.
    Format: Copan FLOQSwab®
    Storage Conditions: 2-30°C
    Assay Compatibility: Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure
    Negative Analyte Products      
    Product NameREDx™ (IVD) Catalogue NumberPROCEEDx™ (RUO) Catalogue Number Product Description
    Negative SampleComing soonVP-99-01 Microbix Negative External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products do not contain any infectious disease diagnostic targets.
    Format: Vial, 1.0 mL
    Storage Conditions: 2-8°C
    Assay Compatibility: MDx, Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure
    Respiratory Negative Swab (REDxTMFLOQ®)
    Negative Swab (PROCEEDxTMFLOQ®)
    RED-S-99-01VP-S-99-01 Microbix Negative Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. The product formulation does not contain any infectious disease diagnostic targets.
    Format: Copan FLOQSwab®
    Storage Conditions: 2-30°C
    Assay Compatibility: Immuno

    Click here to view Microbix QAPs™ Gastrointestinal brochure