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Human papillomavirus External Quality Controls
Verified performance and easy-to-use Human Papillomavirus (HPV) panel.
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 Controls Solutions
Microbix offers inactivated multiplex HPV16/18/45, HPV31/33/66, and HPV39/51/52 liquid and swab products for use with extended high-risk HPV genotyping assays.
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Products
| Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
| Single Analyte Products | |||
| HPV 16 Positive | RED-62-16 | VP-62-16 | Microbix HPV 16 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 16 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 16 Positive External Quality Controls have verified performance with Abbott RealTime High Risk HPV Assay, Cepheid Xpert® HPV Assay, Hologic Aptima® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 18 Positive | RED-62-18 | VP-62-18 | Microbix HPV 18 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 18 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 18 Positive External Quality Controls have verified performance with Abbott RealTime High Risk HPV Assay, Cepheid Xpert® HPV Assay, Hologic Aptima® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 31 Positive | RED-62-31 | VP-62-31 | Microbix HPV 31 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 31 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 31 Positive External Quality Controls have verified performance with Abbott RealTime High Risk HPV Assay, Cepheid Xpert® HPV Assay, Hologic Aptima® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 33 Positive | RED-62-33 | VP-62-33 | Microbix HPV 33 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 33 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 33 Positive External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 39 Positive | RED-62-39 | VP-62-39 | Microbix HPV 39 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 39 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 39 Positive External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 45 Positive | RED-62-45 | VP-62-45 | Microbix HPV 45 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 45 genetic material, suspended in ThinPrep® PreservCyt®. Microbix HPV 45 Positive External Quality Controls have verified performance with Abbott RealTime High Risk HPV Assay, Cepheid Xpert® HPV Assay, Hologic Aptima® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV Test, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 51 Positive | RED-62-51 | VP-62-51 | Microbix HPV 51 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV 51 whole genome nucleic acid and human cells suspended in ThinPrep® PreservCyt®. Microbix HPV 51 Positive External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 52 Positive | RED-62-52 | VP-62-52 | Microbix HPV 52 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV 52 whole genome nucleic acid and human cells suspended in ThinPrep® PreservCyt®. Microbix HPV 52 Positive External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 66 Positive | RED-62-66 | VP-62-66 | Microbix HPV 66 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV 66 whole genome and human cells, suspended in ThinPrep® PreservCyt®. Microbix HPV 66 Positive External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| High-risk HPV Negative (HPV 67) | RED-62-67 | VP-62-67 | Microbix high-risk HPV Negative (HPV 67) External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV 67 whole genome nucleic acid and human cells suspended in ThinPrep® PreservCyt®. Microbix high-risk HPV Negative External Quality Controls have verified performance with Abbott RealTime High Risk HPV Assay, Cepheid Xpert® HPV Assay, Hologic Aptima® HPV Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV test, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 16 Positive Swab | RED-S-62-16* | VP-S-62-16 | Microbix HPV 16 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 16 genetic material desiccated on a Copan FLOQSwab®. Microbix HPV 16 Positive Swab External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, GeneProof® HPV qPCR Assay, Seegene Novaplex™ II HPV28 Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
*REDx products are only for sale in Canada and the United States |
| HPV 18 Positive Swab | RED-S-62-18* | VP-S-62-18 | Microbix HPV 18 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 18 genetic material desiccated on a Copan FLOQSwab®. Microbix HPV 18 Positive Swab External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, GeneProof® HPV qPCR Assay, Seegene Novaplex™ II HPV28 Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
*REDx products are only for sale in Canada and the United States |
| HPV 45 Positive Swab | RED-S-62-45* | VP-S-62-45 | Microbix HPV 45 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 45 genetic material desiccated on a Copan FLOQSwab®. Microbix HPV 45 Positive Swab External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, GeneProof® HPV qPCR Assay, Seegene Novaplex™ II HPV28 Assay,ULISSE BioMed HPV Selfy Assay, High Risk HPV EliTe Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
*REDx products are only for sale in Canada and the United States |
| Multiple Analyte Products | |||
| HPV 16/18/45 Positive | RED-62-M1 | VP-62-M1 | Microbix HPV 16/18/45 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 16, 18, and 45 genetic materials, suspended in ThinPrep® PreservCyt®. Microbix HPV 16/18/45 External Quality Controls have verified performance with Abbott Alinity m HR HPV Assay, Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, Roche cobas® 4800 and cobas® 6800/8800 HPV test, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 31/33/66 Positive | RED-62-M2 | VP-62-M2 | Microbix HPV 31/33/66 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV type 31, 33, and 66 whole genome nucleic acid, and human cells suspended in ThinPrep® PreservCyt®. Microbix HPV 31/33/66 External Quality Controls have verified performance with Abbott Alinity m HR HPV Assay, Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 39/51/52 Positive | RED-62-M3 | VP-62-M3 | Microbix HPV 39/51/52 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV type 39, 51, and 52 whole genome nucleic acid, and human cells suspended in ThinPrep® PreservCyt®. Microbix HPV 39/51/52 External Quality Controls have verified performance with Abbott Alinity m HR HPV Assay, Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, Seegene Anyplex™ II HPV HR Detection Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| HPV 16/18/45 Positive Swab | RED-S-62-M1* | VP-S-62-M1 | Microbix HPV 16/18/45 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated human epithelial cells with integrated and episomal HPV 16, 18, and 45 genetic material desiccated on a Copan FLOQSwab®. Microbix HPV 16/18/45 Positive Swab External Quality Controls have verified performance with Cepheid Xpert® HPV Assay, BD Onclarity™ HPV Assay, GeneProof® HPV qPCR Assay, Seegene Novaplex™ II HPV28 Assay, ULISSE BioMed HPV Selfy Assay, EliTech High Risk HPV EliTe Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
*REDx products are only for sale in Canada and the United States |
| HPV 31/33/66 Positive Swab | Coming soon | VP-S-62-M2 | Microbix HPV 31/33/66 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV type 31, 33, and 66 whole genome nucleic acid, and human cells desiccated on a Copan FLOQSwab®. Microbix HPV 31/33/66 Positive Swab External Quality Controls have verified performance with Seegene Novaplex™ II HPV28 Assay, BD Onclarity™ HPV Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| HPV 39/51/52 Positive Swab | Coming soon | VP-S-62-M3 | Microbix HPV 39/51/52 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain HPV type 39, 51, and 52 whole genome nucleic acid, and human cells desiccated on a Copan FLOQSwab®. Microbix HPV 39/51/52 Positive Swab External Quality Controls have verified performance with Seegene Novaplex™ II HPV28 Assay, BD Onclarity™ HPV Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
| Negative Analyte Products | |||
| STI Negative | RED-99-M1 | VP-99-M1 | Microbix HPV Negative External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with human cells, suspended in ThinPrep® PreservCyt®. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx
|
| NAAT Negative Swab (PROCEEDxTMFLOQ®) | Coming Soon | VP-S-99-M4 | Microbix NAAT Negative Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with human cells desiccated on Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx
|
Frequently Asked Questions
What specific HPV genotypes are covered by the HPV External Quality Control panel?
The HPV panel includes liquid formulations of HPV types 16, 18, 31, 33, 39, 45, 51, 52, 66, and 67 (high-risk negative) suspended in Hologic Thin Prep® PreservCyt® and multiplex Copan FLOQSwab® formulations (HPV16/18/45, HPV31/33/66, HPV39/51/52) that are suitable for self-collection initiatives.
Are these controls suitable for use with clinical diagnostic HPV tests?
Yes, our controls are suitable for use in HPV testing.
Does Microbix offer custom sample kits for verification/validation studies and operator training?
Our HPV panel includes a dedicated low risk/non-oncogenic HPV 67 negative sample to evaluate high-risk HPV test specificty and cross-reactivity
What is the shelf life of your HPV external quality controls?
The shelf life of our HPV 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
Your Reliable Source of External Quality Controls for Extended High-Risk HPV Genotyping
The Human Papillomavirus (HPV) panel includes liquid formulations of HPV types 16, 18, 31, 33, 39, 45, 51, 52, 66, and 67 (high-risk negative) suspended in Hologic ThinPrep® PreservCyt® and Copan FLOQSwab® formulations of HPV types 16, 18, 31, 33, 39, 45, 51, 52 and 66. All products are formulated with inactivated whole-genome samples that contain common assay targets (E1, E6, E7, L1), episomal and integrated viral DNA, viral RNA, proteins, and human DNA.
The panel includes multiplex liquid products (HPV16/18/45, HPV31/33/66 and HPV39/51/52) and novel multiplex swab products (HPV 16/18/45, HPV 31/33/66, HPV 39/51/52) that are suitable for HPV self-collection initiatives.
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