Infectious Disease External Quality Controls

Enhance test monitoring and performance with Microbix’s External Quality Controls (QAPs™).

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.

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.

Technical Resources

Browse our comprehensive selection of resources on infectious diseases and diagnostics.

Proudly Supporting Over 100+ Customers with Leading  Diagnostic Solutions 

“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

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.

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