The makers of rapid COVID-19 tests face strict rules that will let them provide them only to registered labs and health professionals amid fears that do-it-yourself test results could be misinterpreted.
Australia has so far been resistant to widespread use of “point-of-care” tests for the virus, but the products are gaining traction as NSW continues to battle the Delta variant.
Point-of-care tests can be used on-site and generally take just minutes to process, rather than requiring analysis at a laboratory. A number of these products are already registered with the Therapeutic Goods Administration (TGA) for use in Australia.
Whiddon Easton Park Age Care facility is using rapid COVID-19 testing for staff members.Credit:Rhett Wyman
However, guidance from the TGA this week outlines that producers of rapid tests must abide by a strict set of supply guidelines to ensure their products are properly used.
The regulator says this is because “the correct interpretation of results obtained from these tests requires the involvement of a suitably qualified healthcare professional”.
Suppliers of COVID-19 rapid antigen tests can only sell these to registered labs, medical practitioners, or organisations or businesses where there is a health practitioner present for supervising and interpreting the tests.
They cannot be provided for the purpose of self-testing at home, and companies must provide training to health practitioners about the correct way to use and interpret the tests.
Point-of-care serology tests, which are designed to detect antibodies after a person has been infected with the virus, also face restrictions and cannot be supplied to pharmacists for sale.
The TGA said in its guidance that the restrictions were in place to ensure results were interpreted correctly by qualified professionals.









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