Australia’s best COVID rapid antigen tests, as rated by the TGA

Datetime:2022-01-30

Infectious disease expert Paul Griffin told Sunrise that as time passes, and access and availability increase, “it would be best to use the one that has the highest performance that you can find and afford”.

But right now, with shortages across the country, experts say it’s important not to stress if you can’t find the exact brand you were looking for.

“Whatever test you can get is better than doing no test,” he said, adding that those who can only find those with lower sensitivity should test themselves over consecutive days.

RATs approved by the TGA

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 swab

· Cellife Covid-19 Antigen Test Cassette for self-testing - Nasal swab

· Clungene Covid-19 Antigen Rapid Test for self-testing - Nasal swab

· Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) - 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

· Rapid SARS-COV-2 Antigen Test Card Self-test - Nasal swab

· V-Chek COVID-19 Antigen Saliva Test - Saliva

The following have been given the “high sensitivity” label:

· All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H) - Oral fluid

· Hough COVID-19 Home Test - Nasal swab

· 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 Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test - Oral fluid

· Orawell COVID-19 Ag Rapid saliva test device (Self-test) - Saliva

· RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab) - Nasal swab

· TESTSEALABS COVID-19 Antigen Test Cassette - Nasal swab

And these “acceptable sensitivity”:

· CareStart COVID-19 Antigen Home Test - Nasal swab

· Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen) - Saliva

· InnoScreen COVID-19 Antigen Rapid Test Device (Self Test) - Nasal swab

· SARS-CoV-2 Antigen Self Test Nasal - Nasal swab

 

The performance requirements - aligned with technical specifications published by the World Health Organisation and the European Commission - includes a minimum clinical sensitivity of at least 80 %.

This is based on the test’s positive per cent agreement (PPA) - the proportion of individuals that produced a positive test result using a COVID-19 rapid antigen self-test, compared to those with a positive result by PCR test.

The theory is that the greater the sensitivity, the greater chance it has at detecting COVID-19, the less chance of a false negative.

“Acceptable sensitivity” indicates a clinical sensitivity greater than 80% PPA, ‘high sensitivity’ greater than 90% PPA and “very high sensitivity” greater than 95 per cent PPA.