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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.
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Products
| Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
| BACTERIAL | |||
| Single-Target Products | |||
| Campylobacter jejuni Positive Swab | RED-S-123-01* | VP-S-123-01 | Request Quote |
| Campylobacter jejuni Positive | RED-123-01* | VP-123-01 | Request Quote |
| Campylobacter OMP Positive Swab | N/A | VP-S-40-01 | Request Quote |
| Clostridium difficile Positive Swab | RED-S-125-01* | VP-S-125-01 | Request Quote | Clostridium difficile Positive | RED-125-01* | VP-125-01 | Request Quote |
| C.difficile GDH Positive Swab | N/A | VP-S-39-01 | Request Quote |
| Enterotoxigenic E. coli Positive Swab | Coming soon | VP-S-130-01 | Request Quote |
| Enterotoxigenic E. coli Positive | Coming soon | VP-130-01 | Request Quote |
| H. pylori Positive Swab | Coming soon | VP-S-27-01 | View Brochure |
| H. pylori Positive Swab (MDx) | Coming soon | VP-S-27-M1 | Request Quote |
| H. pylori Positive Swab (Low Level) | Coming soon | VP-S-27-L1 | Request Quote |
| Plesiomonas shigelloides Positive Swab | Coming soon | VP-S-131-01 | Request Quote |
| Plesiomonas shigelloides Positive | Coming soon | VP-131-01 | Request Quote |
| Salmonella enteritidis Positive Swab | RED-S-126-01* | VP-S-126-01 | Request Quote |
| Salmonella enteritidis Positive | RED-126-01* | VP-126-01 | Request Quote |
| Shiga toxin-producing E. coli Positive Swab | RED-S-127-01* | VP-S-127-01 | Request Quote |
| Shiga toxin-producing E. coli Positive | RED-127-01* | VP-127-01 | Request Quote |
| Shigella sonnei Positive Swab | RED-S-121-01* | VP-S-121-01 | Request Quote |
| Shigella sonnei Positive | RED-121-01* | VP-121-01 | Request Quote |
| Vibrio parahaemolyticus Positive Swab | Coming soon | VP-S-122-01 | Request Quote |
| Vibrio parahaemolyticus Positive | Coming soon | VP-122-01 | Request Quote |
| Yersinia enterocolitica Positive Swab | Coming soon | VP-S-124-01 | Request Quote |
| Yersinia enterocolitica Positive | Coming soon | VP-124-01 | Request Quote |
| Multi-Analyte Products | |||
| C.difficile GDH/Toxin A/ Toxin B Positive Swab | N/A | VP-S-39-02 | Request Quote |
| Enteric Bacterial Panel 1 Positive Swab | RED-S-120-M1* | VP-S-120-M1 | Request Quote |
| Enteric Bacterial Panel 1 Positive | RED-120-M1* | VP-120-M1 | Request Quote |
| Enteric Bacterial Panel 2 Positive Swab | Coming soon | VP-S-129-M1 | Request Quote |
| Enteric Bacterial Panel 2 Positive | Coming soon | VP-129-M1 | Request Quote |
| Negative-Target Products | |||
| Negative Sample | Coming soon | VP-99-01 | Request Quote |
| NAAT Negative Swab (PROCEEDxTMFLOQ®) | RED-S-99-M4 | VP-S-99-M4 | Request Quote |
| VIRAL | |||
| Single-Target Products | |||
| Adenovirus F40/41 Positive Swab | Coming soon | VP-S-128-01 | Request Quote |
| Adenovirus F40/41 Positive | Coming soon | VP-128-01 | Request Quote |
| Astrovirus Positive Swab | Coming soon | VP-S-117-01 | Request Quote |
| Astrovirus Positive | Coming soon | VP-117-01 | Request Quote |
| Norovirus GI Positive Swab | Coming soon | VP-S-136-01 | Request Quote |
| Norovirus GI Ag Positive Swab | Coming soon | VP-S-132-01 | Request Quote |
| Norovirus GII Positive Swab | Coming soon | VP-S-118-01 | Request Quote |
| Norovirus GII Ag Positive Swab | Coming soon | VP-S-133-01 | Request Quote |
| Norovirus GI Positive | Coming soon | VP-136-01 | Request Quote |
| Norovirus GII Positive | Coming soon | VP-118-01 | Request Quote |
| Rotavirus Positive Swab (MDx) | Coming soon | VP-S-119-01 | Request Quote |
| Rotavirus Positive (MDx) | Coming soon | VP-119-01 | Request Quote |
| Rotavirus Positive | RED-35-01* | VP-35-01 | Request Quote |
| Sapovirus Positive Swab | Coming soon | VP-S-116-01 | Request Quote |
| Sapovirus Positive | Coming soon | VP-116-01 | Request Quote |
| Multi-Target Products | |||
| Enteric Viral Panel Positive Swab | Coming soon | VP-S-115-M1 | Request Quote |
| Enteric Viral Panel Positive | Coming soon | VP-115-M1 | Request Quote |
| Negative-Target Products | |||
| Negative Sample | Coming soon | VP-99-01 | Request Quote |
| NAAT Negative Swab (PROCEEDxTMFLOQ®) | RED-S-99-M4 | VP-S-99-M4 | Request Quote |
| PARASITE | |||
| Single-Target Products | |||
| Cryptosporidium parvum Positive | RED-37-01* | VP-37-01 | Request Quote |
| Giardia lamblia Positive | RED-38-01* | VP-38-01 | Request Quote |
| Multi-Analyte Products | |||
| Cryptosporidium parvum + Giardia lamblia Positive | RED-37-02* | VP-37-02 | Request Quote |
| Negative-Analyte Products | |||
| Negative Sample | Coming soon | VP-99-01 | Request Quote |
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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