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Genital Ulcer External Quality Controls
Verified and reliable Genital Ulcer Disease External Quality Controls for molecular and Immunoassay diagnostics.
Setting the Gold Standard for Infectious Disease Diagnostic Standards
Ready to use External Quality Controls
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.
Global Compliance
Manufactured under the strictest requirements of ISO 13485:2016, Microbix IVD quality controls for genital ulcers are CE marked, registered with the U.S. FDA and Australian TGA and Health Canada establishment licensed.
Unique Diagnostics Solutions
Microbix offers inactivated multiplex HSV 1/HSV 2/VZV/T.pallidum positive swabs that mimic patient specimen formats. Single-analyte positive swab products are also available.
Download Our Full Product Catalogue
Products
| Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | |
| Single Analyte Products | |||
| HSV 1 Positive | RED-02-M1* | VP-02-M1 | Microbix HSV 1 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1 and human cells suspended in a proprietary buffer. Microbix HSV 1 Positive External Quality Controls have verified performance with Roche cobas® 4800, Hologic Aptima®, Meridian Bioscience Alethia®, Luminex ARIES®, DiaSorin Simplexa®, Quidel Solana, Quidel AmpliVue™, Seegene Allplex™ Genital Ulcer Assay, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx, Immuno *Products are QC-released with molecular assays but are also compatible with immunoassays *REDx™ products are only for sale in Canada and the United States
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| HSV 2 Positive | RED-23-M1* | VP-23-M1 | Microbix HSV 2 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 2 and human cells suspended in a proprietary buffer. Microbix HSV 2 Positive External Quality Controls have verified performance with Roche cobas® 4800, Hologic Aptima®, Meridian Bioscience Alethia®, Luminex ARIES®, DiaSorin Simplexa®, Quidel Solana, Quidel AmpliVue™, Seegene Allplex™ Genital Ulcer Assay, and more • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx, Immuno *Products are QC-released with molecular assays but are also compatible with immunoassays *REDx™ products are only for sale in Canada and United States
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| HSV 1 Positive Swab | RED-S-02-01* | VP-S-02-01 | Microbix HSV 1 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1 and human cells desiccated on a Copan FLOQSwab®. Microbix HSV 1 Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| HSV 1 Positive Swab (Low Level) | N/A | VP-S-02-L1 | Microbix HSV 1 Positive Swab (Low Level) External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1 and human cells desiccated on a Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| HSV 2 Positive Swab | RED-S-23-01* | VP-S-23-01 | Microbix HSV 2 Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 2 and human cells desiccated on a Copan FLOQSwab®. Microbix HSV 2 Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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
|
| HSV 2 Positive Swab (Low level) | N/A | VP-S-23-L1 | Microbix HSV 2 Positive Swab (Low Level) External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 2 and human cells desiccated on a Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| Treponema Pallidum Positive Swab | RED-S-80-01* | VP-S-80-01 | Microbix Treponema pallidum Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells containing Treponema pallidum genome and human cells desiccated on a Copan FLOQSwab®. Microbix Treponema pallidum Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioGX Xfree™ Treponema pallidum Assay, SpeeDx PlexPCR® VHS 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
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| Treponema pallidum 47kDa Positive Swab | N/A | VP-S-80-02 | Microbix Treponema pallidum 47 kDa Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells containing Treponema pallidum 47kDa antigen gene and human cells desiccated on a Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| Varicella Zoster Virus Positive Swab | RED-S-03-01* | VP-S-03-01 | Microbix VZV Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Varicella Zoster Virus and human cells desiccated on a Copan FLOQSwab®. Microbix VZV Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® VZV Swab Direct Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| Varicella Zoster Virus Positive Swab (Low Level) | N/A | VP-S-03-L1 | Microbix VZV Positive Swab (Low Level) External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Varicella Zoster Virus and human cells desiccated on a Copan FLOQSwab®. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| Monkeypox West African Positive Swab | Coming soon | VP-S-81-02 | Microbix Monkeypox West African Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated whole-genome Monkeypox virus (West African clade) and human cells desiccated on a Copan FLOQSwab®. Microbix Monkeypox West African Positive Swab External Quality Controls have verified performance with Roche LightMix® Modular Monkeypox Virus Assay , Seegene Novaplex™ MPXV assay, SpeeDx PlexMonkeypox assay, BioGX Xfree™ Monkeypox PCR Assay , Cepheid Xpert® Mpox Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| Multiple Analyte Products | |||
| HSV 1 & HSV 2 Positive | Coming soon | VP-02-M2 | Microbix HSV1 and HSV2 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, Herpes Simplex Virus 2, and human cells suspended in a proprietary buffer. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx, Immuno *Products are QC-released with molecular assays but are also compatible with immunoassays |
| HSV 1 and HSV 2 Positive Swab | RED-S-02-M2* | VP-S-02-M2 | Microbix HSV1 and HSV2 Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, Herpes Simplex Virus 2, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV1 and HSV 2 Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| HSV 1 and VZV Positive Swab | RED-S-02-M3* | VP-S-02-M3 | Microbix HSV1 and VZV Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, Varicella Zoster Virus, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV1 and VZV Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| HSV 1 and T. pallidum Positive Swab | RED-S-02-M4* | VP-S-02-M4 | Microbix HSV1 and T. pallidum Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, cells containing Treponema pallidum genome, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV1 and T. pallidum Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, BioGX Xfree™ Treponema pallidum Assay, SpeeDx PlexPCR® VHS 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 |
| HSV 2 and VZV Positive Swab | RED-S-23-M2* | VP-S-23-M2 | Microbix HSV2 and VZV Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 2, Varicella Zoster Virus, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV2 and VZV Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, DiaSorin Simplexa® VZV Swab Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| HSV 2 and T. pallidum Positive Swab | RED-S-23-M3* | VP-S-23-M3 | Microbix HSV2 and T. pallidum Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 2, cells containing Treponema pallidum genome, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV2 and T. pallidum Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, BioGX Xfree™ Treponema pallidum Assay, SpeeDx PlexPCR® VHS 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 |
| T. pallidum and VZV Positive Swab | RED-S-80-M2* | VP-S-80-M2 | Microbix T. pallidum and VZV Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Varicella Zoster Virus, cells containing Treponema pallidum genome, and human cells desiccated on a Copan FLOQSwab®. Microbix T. pallidum and VZV Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, DiaSorin Simplexa® VZV Swab Direct Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, BioGX Xfree™ Treponema pallidum Assay, SpeeDx PlexPCR® VHS 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 StatesRequest Quote |
| HSV1/HSV2/VZV Positive Swab | RED-S-02-M5* | VP-S-02-M5 | Microbix HSV1/HSV2/VZV Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, Herpes Simplex Virus 2, Varicella Zoster Virus, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV1/HSV2/VZV Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, DiaSorin Simplexa® VZV Swab Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, SpeeDx PlexPCR® VHS 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 |
| HSV1&2/VZV/T. pallidum Positive Swab | RED-S-03-M1 | VP-S-03-M1 | Microbix HSV1&2/VZV/T. pallidum Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Herpes Simplex Virus 1, Herpes Simplex Virus 2, Varicella Zoster Virus, cells containing Treponema pallidum genome, and human cells desiccated on a Copan FLOQSwab®. Microbix HSV1&2/VZV/T. pallidum Positive Swab External Quality Controls have verified performance with Seegene Allplex™ Genital Ulcer Assay, BioFire® FilmArray® Meningitis/ Encephalitis Panel, DiaSorin Simplexa® HSV1&HSV2 Direct Assay, DiaSorin Simplexa® VZV Swab Direct Assay, Meridian Bioscience Alethia® HSV1&2 Assay, BioGX Xfree™ HSV-1, HSV-2, VZV PCR Assay, BioGX Xfree™ Treponema pallidum Assay, SpeeDx PlexPCR® VHS Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx |
| SARS-CoV-2 Negative Swab (REDx™FLOQ®)* NAAT Negative Swab (PROCEEDx™FLOQ®) |
RED-S-99-M4 | 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 * Product is formulated with human cells desiccated on swabs and can be used in context of GUD testing |
| STI Negative | RED-99-M1 | VP-99-M1 | Microbix STI 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 |
| Negative Control Sample | Coming Soon | VP-99-01 | Microbix Negative External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with human cells suspended in PT Buffer. • Format: Vial;1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx |
Frequently Asked Questions
What specific Genital Ulcer External Quality Controls are covered by your panel?
The genital ulcer disease panel includes HSV infection 1 and 2, T.pallidum, varicella zoster virus, and monkeypox as single and multiple analytes in liquid and swab formats.
Do you offer different kit sizes or configurations to suit various testing needs?
Yes – please reference our Custom ONBOARDx kit brochure for more 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 Provider of Genital Ulcer Disease External Quality Controls
The Genital Ulcer Disease panel includes liquid and swab formulations of inactivated Herpes Simplex Virus type 1 and 2, Varicella Zoster Virus, Treponema pallidum, and Monkeypox Virus. All products are whole-workflow controls (including extraction) and are formulated with human cells to meet molecular assay Sample Adequacy Control requirements.
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