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Gastrointestinal External Quality Controls
Setting the Gold Standard for Infectious Disease Diagnostic Standards
Ready to use External Quality Controls
Microbix is the only supplier licensed to manufacture External Quality Controls using Copan’s FLOQSwab® . These controls are room-temperature stable and offer a 2-year shelf life from the date of manufacture when stored at 2–30 °C.
Global Diagnostics Compliance
Microbix External Quality Controls are manufactured under the strict requirements of ISO 13485:2016. Microbix’s IVD External Quality Controls are registered as Class I medical devices with the U.S. FDA and Health Canada. Certain IVD products are also CE-IVD registered and hold Australian TGA registration.
Unique Quality Control Products
Microbix offers inactivated whole-genome parasite External Quality Controls, including Cryptosporidium parvum and Giardia lamblia. Multiplex and single-target liquid products are available.
Download Our Full Product Brochure
Products
| Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | |
| 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 | RED-S-130-01* | VP-S-130-01 | Request Quote |
| Enterotoxigenic E. coli Positive | RED-130-01* | VP-130-01 | Request Quote |
| H. pylori Positive Swab | RED-S-27-01* | VP-S-27-01 | View Brochure |
| H. pylori Positive Swab (MDx) | RED-S-27-M1* | VP-S-27-M1 | Request Quote |
| H. pylori Positive Swab (Low Level) | RED-S-27-L1* | VP-S-27-L1 | Request Quote |
| H. pylori A2143G Clarithromycin Resistant Positive Swab | RED-S-27-M3* | VP-S-27-M3 | Request Quote |
| Plesiomonas shigelloides Positive Swab | RED-S-131-01* | VP-S-131-01 | Request Quote |
| Plesiomonas shigelloides Positive | RED-131-01* | 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 | RED-S-122-01* | VP-S-122-01 | Request Quote |
| Vibrio parahaemolyticus Positive | RED-122-01* | VP-122-01 | Request Quote |
| Yersinia enterocolitica Positive Swab | RED-S-124-01* | VP-S-124-01 | Request Quote |
| Yersinia enterocolitica Positive | RED-124-01* | VP-124-01 | Request Quote |
| Multi-Target Products | |||
| C. difficile GDH/Toxin A/Toxin B Positive Swab | N/A | VP-S-39-02 | Request Quote |
| Enteric Bacterial Panel 1 Positive Swab Formulated with Campylobacter jejuni, Salmonella enteritidis, Shigella sonnei, and STEC |
RED-S-120-M1* | VP-S-120-M1 | Request Quote |
| Enteric Bacterial Panel 1 Positive Formulated with Campylobacter jejuni, Salmonella enteritidis, Shigella sonnei, and STEC |
RED-120-M1* | VP-120-M1 | Request Quote |
| Enteric Bacterial Panel 2 Positive Swab Formulated with Vibrio parahaemolyticus, Yersinia enterocolitica, Plesiomonas shigelloides, and ETEC |
RED-S-129-M1* | VP-S-129-M1 | Request Quote |
| Enteric Bacterial Panel 2 Positive Formulated with Vibrio parahaemolyticus, Yersinia enterocolitica, Plesiomonas shigelloides, and ETEC |
RED-129-M1* | VP-129-M1 | Request Quote |
| VIRAL | |||
| Single-Target Products | |||
| Adenovirus F40/41 Positive Swab | RED-S-128-01* | VP-S-128-01 | Request Quote |
| Adenovirus F40/41 Positive | RED-128-01* | VP-128-01 | Request Quote |
| Astrovirus Positive Swab | RED-S-117-01* | VP-S-117-01 | Request Quote |
| Astrovirus Positive | RED-117-01* | VP-117-01 | Request Quote |
| Norovirus GI Positive Swab | RED-S-136-01* | VP-S-136-01 | Request Quote |
| Norovirus GI Ag Positive Swab | RED-S-132-01* | VP-S-132-01 | Request Quote |
| Norovirus GII Positive Swab | RED-S-118-01* | VP-S-118-01 | Request Quote |
| Norovirus GII Ag Positive Swab | RED-S-133-01* | VP-S-133-01 | Request Quote |
| Norovirus GI Positive | RED-136-01* | VP-136-01 | Request Quote |
| Norovirus GII Positive | RED-118-01* | VP-118-01 | Request Quote |
| Rotavirus Positive Swab (MDx) | RED-S-119-01* | VP-S-119-01 | Request Quote |
| Rotavirus Positive (MDx) | RED-119-01* | VP-119-01 | Request Quote |
| Rotavirus Positive | RED-35-01* | VP-35-01 | Request Quote |
| Sapovirus Positive Swab | RED-S-116-01* | VP-S-116-01 | Request Quote |
| Sapovirus Positive | RED-116-01* | VP-116-01 | Request Quote |
| Multi-Target Products | |||
| Enteric Viral Panel Positive Swab Formulated with Adenovirus F40/41, Astrovirus, Norovirus GI, Norovirus GII, Rotavirus and Sapovirus |
RED-S-115-M1* | VP-S-115-M1 | Request Quote |
| Enteric Viral Panel Positive Formulated with Adenovirus F40/41, Astrovirus, Norovirus GI, Norovirus GII, Rotavirus and Sapovirus |
RED-115-M1* | VP-115-M1 | Request Quote |
| PARASITE | |||
| Single-Target Products | |||
| Cryptosporidium parvum Positive Swab (MDx) | RED-S-37-M1* | VP-S-37-M1 | Request Quote |
| Cryptosporidium parvum Positive (MDx) | RED-37-M1* | VP-37-M1 | Request Quote |
| Cryptosporidium parvum Positive | RED-37-01* | VP-37-01 | Request Quote |
| Cyclospora cayetanensis Positive | Coming soon | ||
| Dientamoeba fragilis Positive | Coming soon | ||
| Entamoeba histolytica Positive Swab | RED-S-138-01* | VP-S-138-01 | Request Quote |
| Entamoeba histolytica Positive | RED-138-01* | VP-138-01 | Request Quote |
| Giardia lamblia Positive Swab (MDx) | RED-S-38-M1* | VP-S-38-M1 | Request Quote |
| Giardia lamblia Positive (MDx) | RED-38-M1* | VP-38-M1 | Request Quote |
| Giardia lamblia Positive | RED-38-01* | VP-38-01 | Request Quote |
| Multi-Target Products | |||
| Enteric Parasite Panel Positive Swab Formulated with Cryptosporidium parvum, Giardia lamblia, and E. histolytica |
RED-S-165-M1* | VP-S-165-M1 | Request Quote |
| Enteric Parasite Panel Positive Formulated with Cryptosporidium parvum, Giardia lamblia, and E. histolytica |
RED-165-M1* | VP-165-M1 | Request Quote |
| Cryptosporidium parvum + Giardia lamblia Positive | RED-37-02* | VP-37-02 | Request Quote |
| Negative Products | |||
| Negative Sample | Coming soon | VP-99-01 | Request Quote |
| NAAT Negative Swab (PROCEEDx™FLOQ®) | RED-S-99-M4 | VP-S-99-M4 | Request Quote |
*Products are registered as Class I medical devices with Health Canada and FDA
Frequently Asked Questions
What are the product storage conditions and shelf-life?
Microbix liquid External Quality Control products should be stored at 2-8°C and are stable for at least 1 year from the date of manufacture. Microbix swab External Quality Control products should be stored at 2-30°C and are stable for 2 years from the date of manufacture.
Are the products formulated with target genes or whole organisms?
Microbix Gastrointestinal External Quality Control products are formulated using native pathogens that have been inactivated to meet biosafety requirements. All products contain the target organism’s whole genome and require extraction.
Are the products quantified?
Microbix External Quality Control products are unassayed materials. For quantified stocks, refer to the QUANTDx product line.
Do you sell verification panels for gastrointestinal assays?
Yes! Microbix offers ONBOARDx kits to support clinical laboratories in onboarding new assays and conducting the required verification studies. Refer to the ONBOARDx kit page for additional details.
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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