Sexually Transmitted External Quality Controls

Accurate and reliable Sexually Transmitted infection (STI) IVD and RUO External Quality Controls.

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 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 Quality Control Solutions

Microbix offers inactivated multiplex CT/NG/TV/MG positive swabs that mimic patient specimen formats. Single-analyte positive swab products are also available.

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Products

Product Name	REDx™ (IVD) Catalogue Number	PROCEEDx™ (RUO) Catalogue Number	Product Description
Single Analyte Products
Chlamydia trachomatis Positive (MDx)	RED-12-M1*	VP-12-M1	Microbix Chlamydia trachomatis Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated native Chlamydia trachomatis and human cells suspended in ThinPrep® PreservCyt®. Microbix Chlamydia trachomatis Positive External Quality Controls have verified performance with BD Max™ System, BD Viper™, Cepheid GeneXpert®, Hologic Aptima®, Roche cobas® 6800/8800, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx *REDx™ products are only for sale in Canada and the United States Request Quote
Chlamydia trachomatis Positive	RED-12-01*	VP-12-01	Microbix Chlamydia trachomatis Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated native Chlamydia trachomatis suspended in a proprietary buffer. Microbix Chlamydia trachomatis Positive External Quality Controls have verified performance with Cepheid GeneXpert®, Quidel Quickvue®, Sekisui OSOM®, and more • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx, Immuno *REDx™ products are only for sale in Canada and the United States Request Quote
Chlamydia trachomatis Positive Swab	RED-S-12-M1*	VP-S-12-M1	Microbix Chlamydia trachomatis Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Chlamydia trachomatis and human cells desiccated on a Copan FLOQSwab®. Microbix Chlamydia trachomatis Positive Swab External Quality Controls have verified performance with Cepheid GeneXpert® CT/NG Assay, Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
Neisseria gonorrhoeae Positive	RED-17-M1*	VP-17-M1	Microbix Neisseria gonorrhoeae Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Neisseria gonorrhoeae and human cells suspended in ThinPrep® PreservCyt®. Microbix Neisseria gonorrhoeae Positive External Quality Controls have verified performance with BD Max™ System, BD Viper™, Cepheid GeneXpert®, Hologic Aptima®, Roche cobas® 6800/8800, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx *REDx™ products are only for sale in Canada and the United States Request Quote
Neisseria gonorrhoeae Positive Swab	RED-S-17-M1*	VP-S-17-M1	Microbix Neisseria gonorrhoeae Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Neisseria gonorrhoeae and human cells desiccated on a Copan FLOQSwab®. Microbix Neisseria gonorrhoeae Positive Swab External Quality Controls have verified performance with Cepheid GeneXpert® CT/NG Assay, Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
Trichomonas vaginalis Positive	RED-61-01*	VP-61-01	Microbix Trichomonas vaginalis Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Trichomonas vaginalis, and human cells suspended in a proprietary buffer. Microbix Trichomonas vaginalis Positive External Quality Controls have verified performance with Cepheid GeneXpert®, Hologic Aptima®, Hologic Panther®, Quidel Solana, Sekisui OSOM®, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx, Immuno *REDx™ products are only for sale in Canada and the United States Request Quote
Trichomonas vaginalis Positive Swab	RED-S-61-M1*	VP-S-61-M1	Microbix Trichomonas vaginalis Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Trichomonas vaginalis and human cells, desiccated on a Copan FLOQSwab®. Microbix Trichomonas vaginalis Positive Swab External Quality Controls have verified performance with Cepheid GeneXpert® TV assay, Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
Mycoplasma genitalium Positive	RED-63-01	VP-63-01	Microbix Mycoplasma genitalium Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain whole genome Mycoplasma genitalium and human cells suspended in ThinPrep® PreservCyt®. Microbix Mycoplasma genitalium Positive External Quality Controls have verified performance with Roche cobas® TV/MG assay, Hologic Aptima® Mycoplasma genitalium Assay, SpeeDx ResistancePlus® MG Assay, EliTechGroup STI PLUS ELITe MGB® Assay, Diagenode S-DiaMGTV™ Assay, and more. • Format: Vial: 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx Request Quote
Mycoplasma genitalium Positive Swab	RED-S-63-M1*	VP-S-63-M1	Microbix Mycoplasma genitalium Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that conatin whole genome Mycoplasma genitalium and human cells, desiccated on a Copan FLOQSwab®. Microbix Mycoplasma genitalium Positive Swab External Quality Controls have verified performance with Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
Mycoplasma genitalium A2059G Positive Swab	RED-S-63-02	VP-S-63-02	Microbix M. genitalium A2059G Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Mycoplasma genitalium whole genome with A2059G point mutation in the 23S rRNA gene and human cells, desiccated on a Copan FLOQSwab®. Microbix M. genitalium A2059G Positive Swab External Quality Controls have verified performance with SpeeDx ResistancePlus® MG Assay, EliTechGroup Macrolide –R/MG ELITe MGB® Assay, Seegene Allplex™ MG & AziR Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx Request Quote
Mycoplasma genitalium A2058G Positive Swab	RED-S-63-03	VP-S-63-03	Microbix M. genitalium A2058G Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Mycoplasma genitalium whole genome with A2058G point mutation in the 23S rRNA gene and human cells, desiccated on a Copan FLOQSwab®. Microbix M. genitalium A2058G Positive Swab External Quality Controls have verified performance with SpeeDx ResistancePlus® MG Assay, EliTechGroup Macrolide –R/MG ELITe MGB® Assay, Seegene Allplex™ MG & AziR Assay, Seegene Allplex™ CT/NG/MG/TV Assay, Hologic Altima M.genitalium Assay, Abott Alinity m STI Assay, Hain Lifescience FluoroType STI Assay, BioCorp BC-Mycoplasma Kit, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx Request Quote
Mycoplasma genitalium A2059C Positive Swab	RED-S-63-04	VP-S-63-04	Microbix M.genitalium A2059C Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Mycoplasma genitalium whole genome with A2059C point mutation in the 23S rRNA gene and human cells, desiccated on a Copan FLOQSwab®. Microbix M. genitalium A2059C Positive Swab External Quality Controls have verified performance with SpeeDx ResistancePlus® MG Assay, EliTechGroup Macrolide –R/MG ELITe MGB® Assay, Seegene Allplex™ MG & AziR Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx Request Quote
Mycoplasma genitalium A2058T Positive Swab	RED-S-63-05	VP-S-63-05	Microbix M.genitalium A2058T Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Mycoplasma genitalium whole genome with A2058T point mutation in the 23S rRNA gene and human cells, desiccated on a Copan FLOQSwab®. Microbix M. genitalium A2058T Positive Swab External Quality Controls have verified performance with SpeeDx ResistancePlus® MG Assay, EliTechGroup Macrolide –R/MG ELITe MGB® Assay, Seegene Allplex™ MG & AziR Assay, and more. • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx Request Quote
Mycoplasma genitalium A2058C Positive Swab	RED-S-63-06	VP-S-63-06	Microbix M. genitalium A2058C Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Mycoplasma genitalium whole genome with A2058C point mutation in the 23S rRNA gene and human cells, desiccated on a Copan FLOQSwab®. Microbix M. genitalium A2058C Positive Swab External Quality Controls have verified performance with SpeeDx ResistancePlus® MG Assay, EliTechGroup Macrolide –R/MG ELITe MGB® Assay, Seegene Allplex™ MG & AziR Assay, Seegene Allplex™ CT/NG/MG/TV Assay, Hologic Altima M.genitalium Assay, Abott Alinity m STI Assay, Hain Lifescience FluoroType STI Assay, BioCorp BC-Mycoplasma Kit, and more. . • Format: Copan FLOQSwab® • Storage Conditions: 2-30°C • Assay Compatibility: MDx Request Quote

Product Name	REDx™ (IVD) Catalogue Number	PROCEEDx™ (RUO) Catalogue Number	Product Description
Multiple Analyte Products
Chlamydia trachomatis + Neisseria gonorrhoeae Positive	RED-12-M2*	VP-12-M2	Microbix Chlamydia trachomatis and Neisseria gonorrhoeae Positive External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and human cells suspended in ThinPrep® PreservCyt®. Microbix Chlamydia trachomatis and Neisseria gonorrhoeae Positive External Quality Controls have verified performance with Abbott RealTime System, Hologic Aptima®, BD Max™ System, BD Viper™, Cepheid GeneXpert®, Roche cobas® 4800, and more. • Format: Vial; 1.0 mL • Storage Conditions: 2-8°C • Assay Compatibility: MDx *REDx™ products are only for sale in Canada and the United States Request Quote
Chlamydia trachomatis and Neisseria gonorrhoeae Positive Swab	RED-S-12-M2*	VP-S-12-M2	Microbix Chlamydia trachomatis and Neisseria gonorrhoeae Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and human cells desiccated on a Copan FLOQSwab®. Microbix Chlamydia trachomatis and Neisseria gonorrhoeae Positive Swab External Quality Controls have verified performance with Cepheid GeneXpert® CT/NG Assay, Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
CT/NG/TV Positive Swab	RED-S-12-M4*	VP-S-12-M4	Microbix CT/NG/TV Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated cells that contain inactivated Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and human cells, desiccated on a Copan FLOQSwab®. Microbix CT/NG/TV Positive External Quality Controls have verified performance with Cepheid Xpert® CT/NG Assay, Cepheid Xpert® TV Assay, Seegene Novaplex CT/NG/MG/TV 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 Request Quote
CT/NG/TV/MG Positive Swab	RED-S-12-M5*	VP-S-12-M5	Microbix CT/NG/TV/MG Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium whole genome nucleic acid, and human cells, desiccated on a Copan FLOQSwab®. Microbix CT/NG/TV/MG Positive External Quality Controls have verified performance with Cepheid Xpert® TV Assay, Cepheid Xpert® CT/NG Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, Seegene Novaplex CT/NG/MG/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote
Trichomonas vaginalis and Mycoplasma genitalium Positive Swab	RED-S-61-M2*	VP-S-61-M2	Microbix Trichomonas vaginalis and Mycoplasma genitalium Positive Swab External Quality Controls are unassayed, whole-workflow samples that simulate clinical specimens. These products are formulated with inactivated Trichomonas vaginalis, cells that contain whole genome Mycoplasma genitalium and human cells desiccated on a Copan FLOQSwab®. Microbix Trichomonas vaginalis and Mycoplasma genitalium Positive Swab External Quality Controls have verified performance with Cepheid GeneXpert® TV assay, Seegene Novaplex CT/NG/MG/TV Assay, Bosch Vivalytic STI Assay, Abbott Alinity m STI Assay, BD MAX™ CT/GC/TV Assay, SpeeDx Plex® CT/GC/TV/MG 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 Request Quote*

Product Name	REDx™ (IVD) Catalogue Number	PROCEEDx™ (RUO) Catalogue Number	Product Description
Negative Analyte Products
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 Request Quote
SARS-CoV-2 Negative Swab (REDxTMFLOQ®)* NAAT Negative Swab (PROCEEDxTMFLOQ®) * The product is formulated with human cells desiccated on swabs and can be used in context of STI testing	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 Request Quote
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 Request Quote

Frequently Asked Questions

What STIs are included in your panel?

The STI External quality control are formulated in liquid and swab formats of chlamydia trachomatis, Neisseria gonorrhoaeae, trichomonas vaginalis, mycoplasma genitalium positive resistance including A2059G, A2058G, A2059C, A2058T, A2058C including multiple analyte products.

What is the shelf life of your STI External Quality control panels?

The shelf life of our STI External quality control panel is 2 years from the manufacturing date. years when the swabs are stored at 2-30°C and the liquids are stored at 2-8°C.

Are the External Quality controls validated for use with various diagnostic testing platforms?

Yes, our STI External Quality Controls are cross-platform compatible and have verified performance against leading IVD assays.

Can I request custom concentrations or formulations for the controls?

Yes, please request further information from our sales team

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 Reliable Source of STI External Quality Controls for Nucleic Acid and Antigen Detection Assays

Microbix’s unique STI external quality controls desiccated on Copan’s FLOQSwab® are room temperature stable products that are easy-to-use and simulate patient specimen formats. All products are formulated with human cells to meet molecular assay Sample Adequacy Control requirements.

The Sexually Transmitted Infection (STI) panel includes liquid and swab formulations of inactivated

Chlamydia trachomatis,
Neisseria gonorrhoeae,
Trichomonas vaginalis, and
Mycoplasma genitalium (wild-type and macrolide resistance strains with A2058G/A2059G/A2058C/A2059C/A2058T point mutations).

Multiplex formulations are available.

Speak to a Customer Service Representative

Let our knowledgeable experts help you secure your products today.

+1-800-794-6694

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