Sexually Transmitted External Quality Controls
Accurate and reliable Sexually Transmitted infection (STI) IVD and RUO External Quality Controls.
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.
Proudly Supporting Over 100+ Customers with Leading Diagnostic Solutions
“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.
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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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
Single Analyte Products | |||
Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
Multiple Analyte Products | |||
Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
Negative Analyte Products | |||
Product Name | REDx™ (IVD) Catalogue Number | PROCEEDx™ (RUO) Catalogue Number | Product Description |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |
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 Click here to view Microbix QAPs™ STI brochure |