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Infectious Disease External Quality Controls
Enhance test monitoring and performance with Microbix’s External Quality Controls (QAPs™).
Setting the Gold Standard for Infectious Disease Diagnostic Standards
Enhancing Molecular Diagnostics Precision
Microbix’s external quality controls are the only controls to be desiccated on Copan’s FLOQSwab® for use in diagnostic labs, EQA providers, diagnostic manufacturers, and more. These swabs are room-temperature stable and are easier to ship with a wide storage range of 2℃-30℃.
Trusted and Compliant Worldwide
Manufactured under the strictest requirements of ISO 13485:2016, Microbix IVD quality controls are CE marked, registered with the U.S. FDA and Australian TGA and Health Canada establishment licensed.
Diverse Infectious Disease Quality Controls
We offer an extensive range of unique product panel offerings for quality control procedures such as our HPV product line, a SARS complete panel, and our multiplex liquid and swab (Copan FLOQSwab) products.
Infectious Disease Quality Control Products
Respiratory Viral & Bacterial Panel
The respiratory viral and bacterial panel covers a range of external quality controls for respiratory molecular and immunoassay diagnostics. These are whole workflow controls that are inactivated to meet clinical laboratory biosafety requirements, and their performance has been verified on leading IVD platforms. This panel includes multiple analyte and negative analyte products.
STI Panel
The sexually transmitted infections panel covers a range of STIs that are formulated with the target pathogen’s whole genome. These external controls and samples are commutable and cross-platform compatible. This panel includes multiple analyte and negative analyte products.
HPV Panel
The human papillomavirus panel is prepared in HOLOGIC® ThinPrep® PreservCyt® and formulated with inactivated whole-genome samples that contain all common assay targets (E1, E6, E7, L1), episomal and integrated viral DNA, viral RNA, proteins, and human DNA. This panel also consists of a low-risk/non-oncogenic HPV 67 Negative sample to evaluate test specificity and rule out cross-reactivity.
Gastrointestinal Panel
The gastrointestinal panel is formulated with the pathogen’s whole genome (MDx) and or the target antigen (EIA). These are whole workflow external controls (including elution and/or extraction) that meet clinical laboratory biosafety requirements. This panel includes multiple analyte and negative analyte products.
ONBOARDx Kits
ONBOARDx™ Kits are assemblies of our PROCEEDx™ Research Use Only (RUO) products. They are helpful tools for verifying the performance of new test systems and training lab personnel. These non-infectious samples are perfect surrogates for hazardous patient samples to confirm the positive and negative detection of specific analytes.
Proficiency Testing
Microbix has long provided viral and bacterial samples for CAP-accredited and ISO 17043-certified external quality assessment and proficiency test (PT) programs. We are experts in cell culture, purification, and inactivation of infectious disease pathogens. We culture well-characterized strains that produce accurate, consistent results.
Genital Ulcer Panel
The Genital Ulcer Panel is formulated with the target pathogen’s whole genome and is commutable and cross-platform compatible. This panel includes multiple analyte and negative analyte products, and their performance has been verified on leading IVD platforms.
Download Our Full Product Catalogue
Frequently Asked Questions
Are your infectious disease external quality controls compliant with relevant regulatory international standards and guidelines?
All Microbix products are manufactured under our strict Quality Management System certified to the requirements of ISO:9001 and ISO:13485 standards. Our external quality controls are FDA-approved, Health Canada-certified, TGA certified and CE-marked. Please view individual product sheets to view which certifications are appropriate for your region.
What pathogens or targets are covered by your infectious disease external quality controls?
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Respiratory viral panel
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Respiratory bacterial panel
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Sexually transmitted infections panel
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Human Papillomavirus panel
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Genital ulcer disease panel
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Gastrointestinal panel
What is the stability and shelf life of your infectious disease external quality controls?
- Liquid formulations are stable from 24 weeks to two years when stored at 2℃-8℃; with a 1mL volume.
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Copan FLOQSwab® formulations are stable for two years when stored at 2℃-30℃.
- Samples can be eluted in your choice of media.
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 for Infectious Disease Quality Control Products
Our external quality controls are manufactured from native pathogens or synthetic whole-genome materials to simulate patient samples that are stable for up to two years. These controls are available in swab (Copan FLOQSwab®) and liquid formulations and are compatible with immunoassays and nucleic acid diagnostic assays.
Our IVD brand (REDx™) products are unassayed controls that can be used for ongoing QC, benchmarking lab molecular testing performance, operator training & 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. Additionally, we offer customized Onboarding (ONBOARDx™) kits to verify the performance of new test systems and train lab personnel. Our ONBOARDx kits contain positive and negative samples from our PROCEEDx (RUO) product line.
Microbix offers multiple panels to cover your testing needs including respiratory viral panel, respiratory bacterial panel, sexually transmitted infections panel, genital ulcer disease panel, and gastrointestinal panel.
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News & Insights from Our Diagnostics Experts
KOL Collaborators Present Microbix HPV Test-Control Results
announces that it is presenting results of a novel Quality Assessment Product (“QAP™”) for supporting patient diagnosis and tissue analysis relating to infection with the Herpes Simplex Virus (“HSV”) ...
Microbix Presents Novel HSV Test Control at EMMD
announces that it is presenting results of a novel Quality Assessment Product (“QAP™”) for supporting patient diagnosis and tissue analysis relating to infection with the Herpes Simplex Virus (“HSV”) ...
Microbix Achieves Essential EU Regulatory Accreditations
Microbix announces that it has upgraded its European Union (“EU”) regulatory compliance for its diagnostic assay quality assessment products (“QAPs™”)....