Currently, the Therapeutic Goods Administration (TGA), needs to separately approve the same rapid Covid test for use in two different settings: at home through self-testing, or at various points of care under the supervision of a health practitioner of staff member.Out of the 22 home tests approved by the TGA only one is made locally, while 16 are sourced from China, two from the US and the others from Korea, Singapore and Germany.However, at least two Australian companies who have applications yet to be approved by the TGA for rapid antigen tests, despite already supplying to overseas markets including Europe and North America.It comes pharmacists around Australia are struggling to supply rapid antigen tests and catch up to demand, with chemist shelves stripped bare of the tiny strips of plastic.Here is a full list of companies that have been approved by the TGA, and some that are still waiting for their approval.AUSTRALIAN COMPANIES WAITING FOR APPROVAL ELLUME For Brisbane-based manufacturer, Ellume, the slow uptake of RATs in Australia has been a main source of frustration. The company is now shipping more than 700,000 of its kits to the US each week after the US government pounced on Ellume’s technology, granting it $US30m to fast track production.Ellume is now focused on the the US market despite Australia facing widespread shortages. Compounding the limits on supply, is the state governments now accepting RAT tests to allow cross border travel. Up until the start of the month, pathology-based testing – which receives a Medicare rebate of $85 a test – were the only way to gain access to states with relatively few cases, like Queensland.ANTEOTECH Anteotech chief executive Derek Thomson told the Courier-Mail in December that it was “quite frustrating” his 15-minute Covid-19 test was tied up in extended approval delays despite being widely used in Europe and given the current desperate need for a screening solution in Australia.NED-4835-rapid-Covid-testAPPROVED RAPID ANTIGEN TESTSAll Test Covid-19 Antigen Rapid Test (Oral Fluid) Self-TestManufacturer: Hangzhou Alltest Biotech Co Ltd (China)All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab)Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)CareStart Covid-19 Antigen Home TestManufacturer: Access Bio Inc (United States of America)Cellife Covid-19 Antigen Test Cassette for self-testingManufacturer: Hangzhou Testsea BiotechnologyClungene Covid-19 Antigen Rapid Test for self-testingManufacturer: Hangzhou Clongene Biotech Co Ltd (China)Ecotest Covid-19 Antigen Saliva Test kit Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)Flowflex SARS-CoV-2 Antigen Rapid Test Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)Flowflex SARS-CoV-2 Antigen Rapid Test Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)Hough Covid-19 Home TestManufacturer: BIOHIT Healthcare (Hefei) Co Ltd (China)InnoScreen COVID-19 Antigen Rapid Test Device Manufacturer: Innovation Scientific Pty Ltd (Australia)JusChek Covid-19 Antigen Rapid Test (Oral Fluid)Manufacturer: Hangzhou Alltest Biotech Co LtdJusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab)Manufacturer: Hangzhou Alltest Biotech Co LtdLYHER Novel coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)My Covid Test Antigen Rapid Test (Oral Fluid) Manufacturer: Hangzhou Alltest Biotech Co Ltd ChinaOnsite Covid-19 Ag Self Test Manufacturer: CTK Biotech Inc (USA)Orawell COVID-19 Ag Rapid saliva test device Manufacturer: Jiangsu Well Biotech Co Ltd (China)Panbio COVID-19 Antigen Self-Test Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)Rapid SARS-COV-2 Antigen Test Card Self-test Manufacturer: MP Biomedicals Asia Pacific Pte Ltd (Singapore)RightSign Covid-19 Antigen Rapid Test Cassette (Nasal Swab) Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)SARS-CoV-2 Antigen Self Test Nasal Manufacturer: SD Biosensor Inc (Korea – Republic of)TESTSEALABS COVID-19 Antigen Test CassetteManufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)V-Chek COVID-19 Antigen Saliva Test Manufacturer: Guangzhou Decheng Biotechnology Co Ltd (China)
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