Datametrex AI Limited announced that the Company has submitted a Medical Devices Interim Order Request Form to approve PCL, Inc.’s COV05 COVID19 Rapid Antigen Detection Kits to Health Canada. This application is made under IO Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act signed by the Minister of Health on August 24, 2020, for PCLCOV05 COVID19 Rapid Antigen Detection Kits. This IO will allow Health Canada to issue expedited review and approval for the sale of these test kits in Canada. This application is made under IO Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act signed by the Minister of Health on August 24, 2020, for PCLCOV05 COVID19 Rapid Antigen Detection Kits. This IO will allow Health Canada to issue expedited review and approval for the sale of these test kits in Canada. These test kits are suitable for point of care tests. No extra equipment is needed. They are simple to use and results are available in 10 minutes. According to PCL the clinical sensitivity (confirmed the actual positive of the approved person where approved person tested positive with a PCR nucleic test) is 86.49% and the clinical specificity (confirmed the actual negative of the negative person where the negative person tested negative with a PCR nucleic test) is 97.87%. Early detection using rapid tests will also provide further protection to Canada’s front-line workers, especially health care professionals. The following certifications have been awarded to these PCL Antigen Test Kits: CE Certificate, Korea KPMG, FIND Listed, UNGM Supplier. Countries includes the EU, 2 countries in the Middle East- Qatar and UAE, India, Russia, 3 countries in Latin America- Guatemala, Ecuador, and Colombia. The PCL Inc. Antigen Detection kit has the CE Certificate meaning that the manufacturer and products have met EU declaration of standards for health, safety, and environmental protection, allowing this product to be sold within the 22 countries in the European Economic Area. Health Canada must approve these COVID-19 test kits before they can be used in Canada. The Company plans to sell these kits in all countries where the kits have been approved for sale. Datametrex anticipates that it will have little or no upfront costs associated with importing these test kits. Assuming Health Canada approves the test kits and they are subsequently purchased by the Canadian government, manufacturer will ship the test kits directly to the Canadian government or hospitals, and Datametrex will not be involved in the shipping, warehousing or distribution process. The clinical performance of the PCL COVID-19 Ag Rapid FIA was evaluated in two different institutions compared to RT-PCR positive cases. Positive% is 86.49% (95% CI: 70.43-94.92%) and negative% agreement is 97.87% (95% CI: 87.28%-99.89%) in the PCL COVID-19 Ag Ripid FIA.