HPV 51 Coming VP-62-51 Application: PROCEEDx™ samples are Research use only soon VP-62-52 (RUO) products for use in test system IQ/OQ/PQ, HPV 52 VP-62-66 Verification & Validation, and Training. Coming VP-62-67 Assay Compatibility: Nucleic acid testing HPV 66 soon Format: Vial (1 mL) HPV 67 (high-risk Coming Application: PROCEEDx™ samples are Research use only negative) soon (RUO) products for use in test system IQ/OQ/PQ, Verification & Validation, and Training. Multiplex Coming Assay Compatibility: Nucleic acid testing -HPV 16 Positive soon Format: Vial (1 mL) -HPV 18 Positive -HPV 45 Positive Coming Application: PROCEEDx™ samples are Research use only soon (RUO) products for use in test system IQ/OQ/PQ, Multiplex Verification & Validation, and Training. -HPV 31 Positive Coming Assay Compatibility: Nucleic acid testing -HPV 33 Positive soon Format: Vial (1 mL) -HPV 66 Positive Coming Application: PROCEEDx™ samples are Research use only Multiplex soon (RUO) products for use in test system IQ/OQ/PQ, -HPV 51 Positive Verification & Validation, and Training. -HPV 52 Positive RED-99-M1 Assay Compatibility: Nucleic acid testing -HPV 39 Positive Format: Vial (1 mL) STI Negative Multiple Analyte Products Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, VP-62-M1 Verification & Validation, and Training. Assay compatibility: Nucleic acid testing Format: Vial (1 mL) Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, VP-62-M2 Verification & Validation, and Training. Assay compatibility: Nucleic acid testing Format: Vial (1 mL) Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, VP-62-M3 Verification & Validation, and Training. Assay compatibility: Nucleic acid testing Format: Vial (1 mL) Negative Analyte Products Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, VP-99-M1 Verification & Validation, and Training. REDx™ used for IVD Quality Control. Assay Compatibility: Nucleic acid testing Format: Vial (1 mL) 51
3.3.5 Gastrointestinal Products LIQUID FORMULATIONS QAPs™ for Gastrointestinal and Immunoassay Diagnostics Contain target pathogen’s whole-viral genome Whole-process samples (including extraction) Inactivated to meet clinical laboratory biosafety requirements Commutable and cross-platform compatible Stable at 2-8°C; 1mL vials Verified performance on leading IVD platforms 52
3.3.5 Gastrointestinal Products Gastrointestinal Panel Product Name REDx™ (IVD) PROCEEDx™ Product Description Catalogue Number (RUO) Catalogue Cryptosporidium parvum Positive Number Giardia lamblia Single Analyte Products Positive Application: PROCEEDx™ samples are Rotavirus Positive Research use only (RUO) products for use in Cryptosporidium Coming soon VP-37-01 test system IQ/OQ/PQ, Verification & parvum + Giardia Coming soon Validation, and Training. Coming soon lamblia Mixed Assay Compatibility: Antigen testing Positive Format: Vial (1 mL) Negative Sample Application: PROCEEDx™ samples are Research use only (RUO) products for use in VP-38-01 test system IQ/OQ/PQ, Verification & Validation, and Training. Assay Compatibility: Antigen testing Format: Vial (1 mL) Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & VP-35-01 Validation, and Training. Assay Compatibility: Antigen testing Format: Vial (1 mL) Multiple Analyte Products Application: PROCEEDx™ samples are Research use only (RUO) products for use in Coming soon VP-37-02 test system IQ/OQ/PQ, Verification & Validation, and Training. Assay Compatibility: Antigen testing Format: Vial (1 mL) Negative Analyte Products Application: PROCEEDx™ samples are Research use only (RUO) products for use in test system IQ/OQ/PQ, Verification & Coming soon VP-99-01 Validation, and Training. Assay Compatibility: Nucleic acid testing, Antigen testing Format: Vial (1 mL) 53
3.4 ONBOARDx™ Kits ONBOARDx™ Kits are assemblies of our PROCEEDx™ Research Use Only (RUO) products. They are helpful tools for verifying the performance of new test systems and training lab personnel. These non-infectious samples are perfect surrogates for hazardous patient samples to confirm positive and negative detection of specific analytes. ONBOARDx™ Kits are available in liquid form for refrigerated storage or at ambient temperature on Copan FLOQSwabs® and we have several versions containing a range of respiratory samples. 54
3.4 ONBOARDx™ Kits ONBOARDx™ Kits Product Name PROCEEDx™ (RUO) Product Description ONBOARDx™FLOQ® Catalogue Number SARS-CoV-2 Variant Contains: VP-SK-CVAR-01 PROCEEDx™FLOQ® SARS-CoV-2 B.1.1.7 Positive swab x 3 Swab Kit PROCEEDx™FLOQ® SARS-CoV-2 B.1.351 Positive swab x 3 VP-SK-CVAR-02 PROCEEDx™FLOQ® SARS-CoV-2 P.1 Positive swab x 3 ONBOARDx™FLOQ® PROCEEDx™FLOQ® SARS-CoV-2 WT Positive swab x 3 SARS-CoV-2 Variant VP-SK-FLU-01 VP-SK-FLU-02 Contains: Swab Kit PROCEEDx™FLOQ® SARS-CoV-2 B.1.1.7 Positive swab x 3 VP-K-RESP-01 PROCEEDx™FLOQ® SARS-CoV-2 B.1.351 Positive swab x 3 ONBOARDx™ FLU Kit VP-SK-RSV-01 PROCEEDx™FLOQ® SARS-CoV-2 P.1 Positive swab x 3 VP-SK-RSV-02 PROCEEDx™FLOQ® SARS-CoV-2 B.1.617 Positive Swab x 3 ONBOARDx™ FLU Kit 2 VP-K-COV2-01 PROCEEDx™FLOQ® SARS-CoV-2 WT Positive swab x 3 VP-SK-RESP-01 ONBOARDx™ Respiratory Contains: Kit PROCEEDx™FLOQ® Influenza A Positive swab x 10 PROCEEDx™FLOQ® Influenza B Positive swab x 10 ONBOARDx™ RSV Kit PROCEEDx™FLOQ® Respiratory Swab Negative Sample x 4 ONBOARDx™ RSV Kit 2 Contains: ONBOARDx™ SARS-CoV- PROCEEDx™FLOQ® Influenza A Positive swab x 20 PROCEEDx™FLOQ® Influenza B Positive swab x 20 2 Kit PROCEEDx™FLOQ® Respiratory Swab Negative Sample x 8 ONBOARDx™FLOQ® Contains: Respiratory Swab Kit PROCEEDx™ SARS-CoV-2 Positive (0.5mL) vial x 3 PROCEEDx™ Influenza A Positive (1mL) vial x 3 PROCEEDx™ Influenza B Positive (1mL) vial x 3 PROCEEDx™ RSV Positive (1mL) vial x 3 Contains: PROCEEDx™FLOQ® RSV Positive Swab x 10 PROCEEDx™FLOQ® Respiratory Swab Negative Sample x 2 Contains: PROCEEDx™FLOQ® RSV Positive Swab x 20 PROCEEDx™FLOQ® Respiratory Swab Negative Sample x 4 Contains: PROCEEDx™ SARS-CoV-2 Positive (0.5mL) vial x 8 PROCEEDx™ SARS-CoV-2 Negative (0.5mL) vial x 4 Contains: PROCEEDx™FLOQ® SARS-CoV-2 Positive swab x 3 PROCEEDx™FLOQ® Influenza A Positive swab x 3 PROCEEDx™FLOQ® Influenza B Positive swab x 3 PROCEEDx™FLOQ® RSV Positive swab x 3 55
ONBOARDx™FLOQ® VP-SK-RESPAG-02 Contains: Respiratory Swab Kit PROCEEDx™FLOQ® SARS-CoV-2 Antigen Positive swab x 5 VP-SK-COV2AG-01 PROCEEDx™FLOQ® Influenza A Positive swab x 5 ONBOARDx™FLOQ® VP-SK-COV2AG-02 PROCEEDx™FLOQ® Influenza B Positive swab x 5 SARS-CoV-2 Antigen PROCEEDx™FLOQ® Respiratory Swab Negative Sample x 5 VP-SK-COV2-01 Swab Kit Contains: ONBOARDx™FLOQ® PROCEEDx™FLOQ® SARS-CoV-2 Antigen Positive swab x 10 SARS-CoV-2 Antigen PROCEEDx™FLOQ® SARS-CoV-2 Negative swab x 2 Swab Kit Contains: PROCEEDx™FLOQ® SARS-CoV-2 Antigen Positive swab x 15 ONBOARDx™FLOQ® PROCEEDx™FLOQ® SARS-CoV-2 Negative swab x 5 SARS-CoV-2 Swab Kit Contains: PROCEEDx™FLOQ® SARS-CoV-2 Positive swab x 8 PROCEEDx™FLOQ® SARS-CoV-2 Negative swab x 4 56
4.0 Proficiency Test Products 57
4.1 About Our Proficiency Test Products External Quality Assessment (EQA) and Proficiency Testing (PT) Microbix has long provided viral and bacterial samples, for CAP-accredited and ISO 17043 certified external quality assessment and proficiency test (PT) programs. We are experts in cell culture, purification, and inactivation of infectious disease pathogens. We culture well- characterized strains that produce accurate, consistent results. Only available for purchase by accredited EQA program providers 58
5.0 DxTM™ Viral Transport Medium 59
5.0 DxTM™ Viral Transport Medium Microbix’s DxTM™ Viral Transport Medium is a Canadian-made, proprietary IVD Medical Device that is designed for use in the collection and transport of specimens containing viruses, including SARS-CoV-2. The DxTM™ formulation is designed to stabilize available viral particles within a given sample. It is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing clinical laboratory. DxTM™ is suitable for processing using standard procedures for viral nucleic acid testing. DxTM™ is used primarily for transporting patient sample swabs or for transporting materials released into the medium from such swabs. Manufactured under our ISO 13485 Quality Management System, DxTM™ packaging tubes contain 1 or 3 ml of the medium, with the tubes able to accommodate 80 mm and 100 mm breakpoint swabs for transportation. DxTM™ facilitates the collection and transport of samples in areas where refrigeration is not readily available, with validated ambient temperature storage and shipping (2-25°C). The advanced formulation stabilizes viral components and suppresses microbial contamination. DxTM™ Viral Transport Medium is validated for viral nucleic acid testing. It is designed to be non-inactivating so it could also potentially be used for isolating and growing viral pathogens from patient specimens. This was performed in comparison to the Gold-Standard predicate device, where DxTM™ was shown to be equivalent to that Gold-Standard in terms of handling and extraction, thereby assuring the very highest standard of performance. Please contact us directly to learn more about VTM 60
6.0 Distributors Microbix has distribution agreements with high-quality distribution partners, skilled in infectious disease diagnostics technologies, that also supply complementary products to our QAPs™. We believe they will be able to serve you very well technically and with high-quality service. Visit our website to find your distributor. For direct purchases and technical information, please contact [email protected] For local suppliers: You can find our distributors on the map above or contact us directly via the following: Canada Senior Accounts Executive Direct contact person: Shane Niyamuddin p: +1 (905) 361-8910 ext. 228 m: +1 (416) 518-7315 e: [email protected] Western US Region Sales Manager Central US Region Sales Manager Direct contact person: David Bick Direct contact person: Les White p: +1 (951) 852-6402 p: +1 (972) 520-2326 e: [email protected] e: [email protected] 61
265 Watline Ave. Mississauga, ON Canada L4Z 1P3 Tel. 905-361-8910 Fax. 905-361-8911 microbix.com 62
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