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Gastrointestinal External Quality Controls
Whole-workflow gastrointestinal IVD and RUO External Quality Controls for molecular and immunoassay diagnostics.
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.
Download Our Full Product Catalogue
Products
| Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
| Single-Target products | |||
| BACTERIAL | |||
| Campylobacter OMP Positive Swab | N/A | VP-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
|
| Campylobacter jejuni Positive Swab | Coming soon | VP-S-123-01 | Microbix Campylobacter jejuni Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Campylobacter jejuni desiccated on a Copan FLOQSwab®. Microbix Campylobacter jejuni Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Campylobacter jejuni Positive Sample | Coming soon | VP-123-01 | Microbix Campylobacter jejuni Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Campylobacter jejuni suspended in a proprietary buffer. Microbix Campylobacter jejuni Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| C.difficile GDH Positive Swab | N/A | VP-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
|
| 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
|
| Clostridium difficile Positive Swab | Coming soon | VP-S-125-01 | Microbix Clostridium difficile Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Clostridium difficile desiccated on a Copan FLOQSwab®. Microbix Clostridium difficile Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Cdiff Assay, BioFire® FILMARRAY® Gastrointestinal Panel, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Clostridium difficile Positive Sample | Coming soon | VP-125-01 | Microbix Clostridium difficile Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Clostridium difficile suspended in a proprietary buffer. Microbix Clostridium difficile Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Cdiff Assay, BioFire® FILMARRAY® Gastrointestinal Panel, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| 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
|
| Salmonella enteritidis Positive Swab | Coming soon | VP-S-126-01 | Microbix Salmonella enteritidisPositive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Salmonella enteritidisdesiccated on a Copan FLOQSwab®. Microbix Salmonella enteritidis Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Salmonella enteritidis Positive Sample | Coming Soon | VP-126-01 | Microbix Salmonella enteritidisPositive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Salmonella enteritidis suspended in a proprietary buffer. Microbix Salmonella enteritidis Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| Shiga toxin-producing E. coli Positive Swab | Coming soon | VP-S-127-01 | Microbix Shiga toxin-producing E. coli Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shiga toxin-producing E. coli desiccated on a Copan FLOQSwab®. Microbix Shiga toxin-producing E. coli Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Shiga toxin-producing E. coli Positive Sample | Coming Soon | VP-127-01 | Microbix Shiga toxin-producing E. coli Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shiga toxin-producing E. coli suspended in a proprietary buffer. Microbix Shiga toxin-producing E. coli Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| Shigella sonnei Positive Swab | Coming soon | VP-S-121-01 | Microbix Shigella sonnei Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shigella sonnei desiccated on a Copan FLOQSwab®. Microbix Shigella sonnei Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Shigella sonnei Positive Sample | Coming Soon | VP-121-01 | Microbix Shigella sonnei Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shigella sonnei suspended in a proprietary buffer. Microbix Shigella sonnei Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| Enterotoxigenic E. coli Positive Swab | Coming soon | Coming Soon | |
| Enterotoxigenic E. coli Positive Sample | Coming Soon | Coming Soon | |
| Plesiomonas shigelloides Positive Swab | Coming soon | Coming Soon | |
| Plesiomonas shigelloides Positive Sample | Coming Soon | Coming Soon | |
| Vibrio parahaemolyticus Positive Swab | Coming soon | Coming Soon | |
| Vibrio parahaemolyticus Positive Sample | Coming Soon | Coming Soon | |
| Yersinia enterocolitica Positive Swab | Coming soon | Coming Soon | |
| Yersinia enterocolitica Positive Sample | Coming Soon | Coming Soon | |
| VIRAL | |||
| 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
|
| Adenovirus F40/41 Positive Swab | Coming soon | Coming Soon | |
| Adenovirus F40/41 Positive Sample | Coming Soon | Coming Soon | |
| Astrovirus Positive Swab | Coming soon | Coming Soon | |
| Astrovirus Positive Sample | Coming Soon | Coming Soon | |
| Norovirus GI Positive Swab | Coming soon | Coming Soon | |
| Norovirus GI Positive Sample | Coming Soon | Coming Soon | |
| Norovirus GII Positive Swab | Coming soon | Coming Soon | |
| Rotavirus Positive Swab (MDx) | Coming soon | Coming Soon | |
| Rotavirus Positive Sample (MDx) | Coming Soon | Coming Soon | |
| Sapovirus Positive Swab | Coming soon | Coming Soon | |
| Sapovirus Positive Sample | Coming Soon | Coming Soon | |
| PARASITE | |||
| 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
|
| 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
|
| Multi-Target Products | |||
| BACTERIAL | |||
| 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
|
| Enteric Bacterial Panel 1 Positive Swab | Coming soon | VP-S-120-M1 | Microbix Enteric Bacterial Panel 1 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shigella sonnei, Campylobacter jejuni, Salmonella enteritidis, and STEC. desiccated on a Copan FLOQSwab®. Microbix Enteric Bacterial Panel 1 Positive Swab External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Enteric Bacterial Panel 1 Positive Sample | Coming Soon | VP-120-M1 | Microbix Enteric Bacterial Panel 1 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Shigella sonnei, Campylobacter jejuni, Salmonella enteritidis, and STEC suspended in a proprietary buffer. Microbix Enteric Bacterial Panel 1 Positive External Quality Controls have verified performance on various IVD assays, such as BD MAX™ Enteric Bacterial Panel, BioFire® FILMARRAY® Gastrointestinal Panel, RIDA® GENE Bacterial Stool Panel I, Seegene Novaplex™ GI-EB Screening Assay (RUO), and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| Enteric Bacterial Panel 2 Positive Swab*
Product is formulated with inactivated Vibrio parahaemolyticus, Yersenia enterocolitica, ETEC, and Plesiomonas shigelloides. |
Coming soon | Coming Soon | |
| Enteric Bacterial Panel 2 Positive Sample*
Product is formulated with inactivated Vibrio parahaemolyticus, Yersenia enterocolitica, ETEC, and Plesiomonas shigelloides. |
Coming Soon | Coming Soon | |
| VIRAL | |||
| Enteric Viral Panel Positive Swab*
Product is formulated with inactivated Sapovirus, Astrovirus, Norovirus GII, Rotavirus, and Adenovirus |
Coming soon | Coming Soon | |
| Enteric Viral Panel Positive Sample*
Product is formulated with inactivated Sapovirus, Astrovirus, Norovirus GII, Rotavirus, and Adenovirus |
Coming Soon | Coming Soon | |
| PARASITE | |||
| 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
|
| Negative-Target Products | |||
| Negative Sample | Coming soon | VP-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
|
| Respiratory Negative Swab (REDx™FLOQ®) Negative Swab (PROCEEDx™FLOQ®) |
RED-S-99-01 | VP-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
|
| SARS-CoV-2 Negative Swab (REDxTMFLOQ®)
NAAT Negative Swab (PROCEEDxTMFLOQ®) |
RED-S-99-M4 | VP-S-99-M4 | Microbix NAAT Negative Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with human cells desiccated on Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
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.
Testimonials
Proudly Supporting Over 100+ Customers with Leading Diagnostic Solutions
Learn more about how our clients worldwide use Microbix’s product lines to enhance the way they do business.
We considered other external quality controls but selected Microbix QAPs as the best solution to support assay optimization and to significantly simplify QC procedures with minimal to no pipetting steps. Microbix’s technical expertise, product design, performance, and superior customer service are impressive. We look forward to continuing our collaboration.
Robert Martinez, VP of Business Development & Scientific Affairs
We were looking for a set of controls that fully covered the range of high-risk HPV types and Microbix is the only company to have such a portfolio. After an extensive evaluation process, we concluded the performance of Microbix QAPs are exactly what Ulisse needs and the interactions with their team are delightful.
Bruna Marini, COO
MDx testing for HPV improves cervical cancer screening by identifying those at-risk efficiently. Close monitoring of the entire HPV testing workflow is critical to realizing this healthcare goal and Microbix’s HPV QAPs have been selected to support the quality assessment monitoring of the molecular testing process, a vital part of BVO’s quality management system
Dr. Rob Schuurman, National Reference Officer for the Dutch Cervical Cancer Screening Program (BVO)
r-Biopharm is pleased that the program will be delivering world-class diagnostic testing to some of the most remote populations in Australia. It has been a privilege to work with the program’s operational team and Microbix to integrate the use of the best possible test and test-workflow controls into the program
Andreas Simons, Director, Project Management Clinical Diagnostics
We’re pleased to be employing Microbix’s innovative QAPs for this new and important EQA program. Genital ulcers are the cause of a considerable and growing burden of disease that can only be alleviated by way of accurate diagnosis and treatment
Juha Wahlstedt, Sales Director at Labquality
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.
We’ve been using Microbix’s External Quality controls for 3 years specifically from their Respiratory and Sexually Transmitted Infections panels on our instruments. It has helped us ensure accurate and reliable patient results and we’ve been delighted with their performance.
Alfie Zhen Fang, Buyer, Procurement
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.
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