Australia’s most accurate rapid antigen tests have been announced with the release of their official ratings from the country’s medicines regulatory agency.
Australia’s most reliable rapid antigen tests have now been unveiled, with the country’s top health authority now giving the green light to dozens of tests.
The federal government has faced a backlash amid a shortage of RATs after millions of Australians were forced to turn to testing amid pressure from PCR testing sites.
With mixed reviews and accuracy around the tests, the Therapeutic Goods Administration has listed the best tests for an accurate diagnosis after companies waited months for local approval.
The TGA has approved dozens of different rapid antigen test kits and categorized them according to their sensitivity, from “highly sensitive” to “acceptable”.
Only one of the approved home tests is currently being conducted in Australia, with the majority coming from China and others from the US, Korea, Singapore and Germany.
TGA measured the performance of each kit using studies conducted by their manufacturers comparing the results of the kits to a PCR test.
The TGA sets the minimum clinical sensitivity that a test kit must achieve at 80 percent, which they call “acceptable sensitivity.”
A kit that is 90 percent accurate is considered “high sensitivity” and a kit that records a clinical sensitivity greater than 95 percent is considered “very high sensitivity.”
The following COVID-19 self-tests have been approved by the TGA for delivery in Australia.
The following kits were given a “very high sensitivity” Label:
- All Tests Rapid SARS-CoV-2 Antigen Test (Nasal Swab) (ICOV-502H) Self Test – Nasal Swab
- LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (Colloidal Gold) Self Test – Nasal Swab
- Onsite COVID-19 Ag Self Test – Nasal Swab
- Panbio COVID-19 Antigen Self-Test – Nasal Swab
- SARS-COV-2 antigen rapid test self-test – nasal swab
- V-Chek COVID-19 Saliva Antigen Test – Saliva
The following were given “high sensitivity” Label:
- All Tests Rapid COVID-19 Antigen Test (Oral Fluid) Self Test (ICOV-802H) – Oral Fluid
- Hough COVID-19 Heimtest – Nasenabstrich
- JusChek SARS-CoV-2 antigen rapid test (nasal swab) INCP-502H self-test – nasal swab
- JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self Test – Oral Fluid
- My Covid Test Rapid Antigen Test (Oral Fluid) (ICOV-802H) Self Test – Oral Fluid
- Orawell COVID-19 Ag Rapid Saliva Test Device (Self Test) – Saliva
- RightSign COVID-19 Rapid Antigen Test Cassette (Nasal Swab) – Nasal Swab
- TESTSEALABS COVID-19 Antigen Test Cassette – Nasal Scratch
These have been labeled “acceptable sensitivity”:
- CareStart COVID-19 Antigen Heimtest – Nasenabstrich
- Ecotest COVID-19 Antigen Saliva Test Kit (COV-S35Pen) – Saliva
- InnoScreen COVID-19 rapid antigen test device (self-test) – nasal swab
- SARS-CoV-2 antigen self-test nasal – nasal swab
University of Queensland infectious disease physician associate professor Paul Griffin told ABC News that any test approved by the TGA is worth using.
Although he recommended people use the most accurate tests, any test approved by the TGA was fine if bottlenecks persisted.
“I would recommend anything that’s approved by the TGA – we’ve seen them be incredibly rigorous throughout the pandemic in terms of testing and vaccines,” he said.
“If they’ve approved it and it’s available, it’s a test I would support.”