HVIA is working with Australian company Croft Group to make 30,000 TGA approved Rapid Antigen Tests (RAT) available for purchase by HVIA members and stakeholders.
The Clungene Covid-19 Antigen Rapid Test for self-testing is classed as Very High Sensitivity by the Therapeutic Goods Administration (TGA) Australia. (i.e. above 95% accuracy – the highest rating in the market.)
The RAT is a nasal swab available in packs of 5, in carton quantities* to Eastern Australian States addresses.
The next shipment
– Available for distribution to Eastern Australian States
– Orders must be received by COB 31st January 2022 – while stocks last
– Orders must be pre-paid
– The tests are available in carton quantities
*Limited small quantity orders will also be fulfilled while stocks last*
– Free shipping included
– To Eastern Australian States addresses only
– Dispatched from Queensland
– Delivery between 3rd – 7th February 2022
Prices are as follows:
1200 test carton
– 240 x packs of 5
– Incl freight*
– Carton cost: $12,595.00 (incl GST)
5 pack small order (limited stock)
– Incl freight*
– Pack cost: $63.25 (incl GST)
*To Eastern Australian States addresses only
THIS ROUND OF ORDERS IS NOW CLOSED – PLEASE CONTACT HVIA IF YOU ARE INTERESTED IN FURTHER ORDERS
About the RAT tests
Clungene COVID-19 Rapid Antigen Test (RAT) 5 Pack
Rapid Antigen Test provides COVID-19 screening results in 15 – 20 minutes.
The Clungene COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab or nasal swab from individuals who are suspected of COVID-19 within the first seven days of symptoms.
- Name of self-test* and how to use the test
- OnSite COVID-19 Ag Self Test (pdf,2.22Mb)
- Sample type
- Nasal swab
- Australian Sponsor (supplier)
- Hangzhou Clongene Biotech Co Ltd (China)
- Australian Register of Therapeutic Goods
- Clinical Sensitivity
- TGA Date Approved
- 7 January 2022
COVID-19 rapid antigen self-tests approved in Australia
12 January 2022
COVID-19 rapid antigen self-tests that are approved in Australia | Therapeutic Goods Administration (TGA)
The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.
Please refer to the instructions on how to use each test for further information on what sample types the test can be used with (e.g. nasal swab or saliva).
The TGA’s performance requirements for COVID rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. This includes a minimum clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a minimum clinical specificity of at least 98%.
The clinical sensitivity of COVID-19 rapid antigen self-tests is based on the studies performed by the manufacturer which show the positive percent agreement (PPA). PPA is the proportion of individuals that produced a positive test result using a COVID-19 rapid antigen self-test, in comparison with a positive result that was obtained using a more sensitive laboratory PCR test.
The inclusion of this information does not represent TGA endorsement of a particular test as all approved tests meet the performance requirements. The manufacturer’s sensitivity information is also included in the instructions provided with each test.
For each test a comment on the clinical sensitivity is assigned as follows:
- Acceptable sensitivity – clinical sensitivity greater than 80% PPA
- High sensitivity – clinical sensitivity greater than 90% PPA
- Very high sensitivity – clinical sensitivity greater than 95% PPA
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