HPV External Quality Controls
Verified performance and easy-to-use Human Papillomavirus (HPV) panel.
Your Reliable Source for HPV Extended Genotype Positive Controls
Our HPV panel is formulated with inactivated whole-genome samples that contain assay targets (E1, E6, E7, L1), episomal and integrated viral DNA, viral RNA, proteins, and human DNA, prepared in HOLOGIC® ThinPrep® PreservCyt®. These HPV multiplex controls are commutable and cross-platform compatible. The panel includes mixed analyte products such as HPV 16/18/45, HPV 31/33/66, and HPV 39/51/52.
The HPV panel detects liquid formulations of HPV Type 16,18,31,33,39,45,51,52,66, 67 (high-risk) and swab (Copan FLOQSwab®) formulations covering HPV Type 16, 18, 45.
Proudly Supporting Over 100+ Customers with Leading Diagnostic Solutions
“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
Unmatched Stability
Microbix’s external quality controls are the only controls to be desiccated on Copan’s FLOQSwab® for HPV detection 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℃.
Global Diagnostics Compliance
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
Unique Controls Solutions
Extensive range of unique product panel offerings such as our HPV product line, and our multiplex liquid and swab formulated products.
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News & Insights from Our Diagnostics Experts
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Microbix Schedules Release of Results for Q2 Fiscal 2024
Results Release and Webinar Discussion on Morning of May 15, 2024 MISSISSAUGA, CANADA, May 8, 2024 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it expects to file the financial statements and management disclosure and analysis for its second quarter of fiscal 2024 ended March…
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Let our knowledgeable experts help you secure your HPV quality controls today.
Frequently Asked Questions
What specific HPV genotypes are covered by your HPV quality controls?
The HPV panel detects liquid formulations of human papillomavirus Type 16,18,31,33,39,45,51,52,66, 67 (high-risk) and swab (Copan FLOQSwab®) formulations covering HPV Type 16, 18, 45 with multiple analyte products available.
Are these controls suitable for use in clinical diagnostic HPV tests?
Yes, our controls are suitable for use in HPV testing.
What is the source and purity of the HPV DNA or RNA used in your controls?
Our HPV multiplex controls are derived from natural sources.
Do your controls include both high-risk and low-risk HPV genotypes?
Our HPV external quality controls include dedicated low-risk/non-oncogenic HPV 67 negative samples to evaluate HPV test specificity and rule out cross-reactivity.
What is the shelf life of your HPV external quality controls?
Depending on the products, our HPV multiplex controls have a shelf life of 24 weeks to two years from the manufacturing date when stored at 2℃-30℃.
Single Analyte Products | ||||
Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description | Product Brochure |
HPV 16 | RED-62-16 | VP-62-16 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 18 | RED-62-18 | VP-62-18 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 31 | Coming soon | VP-62-31 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 33 | Coming soon | VP-62-33 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 39 | Coming soon | VP-62-39 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 45 | RED-62-45 | VP-62-45 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 51 | Coming soon | VP-62-51 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 52 | Coming soon | VP-62-52 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 66 | Coming soon | VP-62-66 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
HPV 67 (high-risk negative) | Coming soon | VP-62-67 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) | |
Multiple Analyte Products | ||||
Multiplex -HPV 16 Positive -HPV 18 Positive -HPV 45 Positive | Coming soon | VP-62-M1 | Assay compatibility: Nucleic acid testingFormat: Vial (1 mL)Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control. | |
Multiplex -HPV 31 Positive -HPV 33 Positive -HPV 66 Positive | Coming soon | VP-62-M2 | Assay compatibility: Nucleic acid testingFormat: Vial (1 mL)Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control. | |
Multiplex -HPV 51 Positive -HPV 52 Positive -HPV 39 Positive | Coming soon | VP-62-M3 | Assay compatibility: Nucleic acid testingFormat: Vial (1 mL)Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control. | |
Negative Analyte Products | ||||
STI Negative | RED-99-M1 | VP-99-M1 | Application – PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation and Training. REDx™ used for IVD Quality Control.Assay Compatibility – Nucleic acid testingFormat: Vial (1 mL) |