The federal government has received backlash amid a shortage in RATs, after millions of Australians were forced to turn to the tests amid pressure on PCR testing sites.With mixed reviews and accuracy surrounding the tests, the Therapeutic Goods Administration has listed the best tests for an accurate diagnosis, after companies waited for months for local approval.The TGA has approved dozens of different rapid antigen testing kits and categorised them according to their sensitivity, labelled from “highly sensitive” to “acceptable”.Currently only one of the approved home tests is made in Australia, with the majority sourced from China, and others from the US, Korea, Singapore and Germany.The TGA measured the performance of each kit on studies carried out by their manufacturers, which compared the kits’ results with a PCR test.The TGA sets the minimum clinical sensitivity a testing kit must achieve at 80 per cent, which it labels as “acceptable sensitivity”.A kit with 90 per cent accuracy is labelled “high sensitivity” and a kit that records clinical sensitivity greater than 95 per cent is considered to have “very high sensitivity”.The following COVID-19 self-tests have been approved by the TGA for supply in Australia.The following kits have been given a “very high sensitivity” label:All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (ICOV-502H) Self-Test – Nasal swabLYHER Novel coronavirus (Covid-19) Antigen Test Kit (Colloidal Gold) Self-Test – Nasal swabOnsite COVID-19 Ag Self Test – Nasal swabPanbio COVID-19 Antigen Self-Test – Nasal swabRapid SARS-COV-2 Antigen Test Card Self-test – Nasal swabV-Chek COVID-19 Antigen Saliva Test – SalivaThe following have been given the “high sensitivity” label:All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H) – Oral fluidHough COVID-19 Home Test – Nasal swabJusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test – Nasal swabJusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self Test – Oral fluidMy Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test – Oral fluidOrawell COVID-19 Ag Rapid saliva test device (Self-test) – SalivaRightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab) – Nasal swabTESTSEALABS COVID-19 Antigen Test Cassette – Nasal swabThese have been labelled “acceptable sensitivity”:CareStart COVID-19 Antigen Home Test – Nasal swabEcotest COVID-19 Antigen Saliva Test kit (COV-S35Pen) – SalivaInnoScreen COVID-19 Antigen Rapid Test Device (Self Test) – Nasal swabSARS-CoV-2 Antigen Self Test Nasal – Nasal swabUniversity of Queensland infectious disease physician, associate professor Paul Griffin, told ABC News any test approved by the TGA was worth using.Although he recommended people use the most accurate tests, if there continued to be shortages, any TGA-approved test was fine to use.“I’d recommend anything approved by the TGA – we’ve seen throughout the pandemic, with regards to testing and vaccines, that they are incredibly rigorous,” he said.“If they’ve approved it, and it is available, it’s a test I would endorse.”
Powered by WPeMatico
