Several Australian companies are ready to supply rapid antigen tests but are waiting for approval

As millions of people struggle to get a rapid antigen test, some Australian-made companies have created new products. See the full list.

With millions of people struggling to get their hands on a rapid antigen test, several Australian companies have been waiting months to have their tests approved by the health regulator.

Currently, the Therapeutic Goods Administration (TGA), needs to separately approve the same rapid Covid test for use in two different settings: at home through self-testing, or at various points of care under the supervision of a health practitioner of staff member.

Out of the 22 home tests approved by the TGA only one is made locally, while 16 are sourced from China, two from the US and the others from Korea, Singapore and Germany.

JusChek COVID-19 Antigen Rapid Test (Oral Fluid) – Hangzhou Alltest Biotech Co Ltd AS.

However, at least two Australian companies who have applications yet to be approved by the TGA for rapid antigen tests, despite already supplying to overseas markets including Europe and North America.

It comes pharmacists around Australia are struggling to supply rapid antigen tests and catch up to demand, with chemist shelves stripped bare of the tiny strips of plastic.

Here is a full list of companies that have been approved by the TGA, and some that are still waiting for their approval.

AUSTRALIAN COMPANIES WAITING FOR APPROVAL

ELLUME

For Brisbane-based manufacturer, Ellume, the slow uptake of RATs in Australia has been a main source of frustration.

The company is now shipping more than 700,000 of its kits to the US each week after the US government pounced on Ellume’s technology, granting it $US30m to fast track production.

Ellume is now focused on the the US market despite Australia facing widespread shortages. Compounding the limits on supply, is the state governments now accepting RAT tests to allow cross border travel.

Up until the start of the month, pathology-based testing - which receives a Medicare rebate of $85 a test - were the only way to gain access to states with relatively few cases, like Queensland.

Australian Ellume Covid tests Get results in 1 test, not 2* The test is suitable for ages 2 years and above for over-the-counter home use. Clinically proven for use for people with and without symptoms, with accurate test results in 15 minutes.

ANTEOTECH

Anteotech chief executive Derek Thomson told the Courier-Mail in December that it was “quite frustrating” his 15-minute Covid-19 test was tied up in extended approval delays despite being widely used in Europe and given the current desperate need for a screening solution in Australia.

APPROVED RAPID ANTIGEN TESTS

All Test Covid-19 Antigen Rapid Test (Oral Fluid) Self-Test

Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)

All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)

CareStart Covid-19 Antigen Home Test

Manufacturer: Access Bio Inc (United States of America)

Cellife Covid-19 Antigen Test Cassette for self-testing

Manufacturer: Hangzhou Testsea Biotechnology

Clungene Covid-19 Antigen Rapid Test for self-testing

Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)

Ecotest Covid-19 Antigen Saliva Test kit

Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)

Flowflex SARS-CoV-2 Antigen Rapid Test

Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)

Flowflex SARS-CoV-2 Antigen Rapid Test

Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)

Hough Covid-19 Home Test

Manufacturer: BIOHIT Healthcare (Hefei) Co Ltd (China)

InnoScreen COVID-19 Antigen Rapid Test Device

Manufacturer: Innovation Scientific Pty Ltd (Australia)

JusChek Covid-19 Antigen Rapid Test (Oral Fluid)

Manufacturer: Hangzhou Alltest Biotech Co Ltd

JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

Manufacturer: Hangzhou Alltest Biotech Co Ltd

LYHER Novel coronavirus (Covid-19) Antigen Test Kit (colloidal Gold)

Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)

My Covid Test Antigen Rapid Test (Oral Fluid)

Manufacturer: Hangzhou Alltest Biotech Co Ltd China

Onsite Covid-19 Ag Self Test

Manufacturer: CTK Biotech Inc (USA)

Orawell COVID-19 Ag Rapid saliva test device

Manufacturer: Jiangsu Well Biotech Co Ltd (China)

Panbio COVID-19 Antigen Self-Test

Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)

Rapid SARS-COV-2 Antigen Test Card Self-test

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd (Singapore)

RightSign Covid-19 Antigen Rapid Test Cassette (Nasal Swab)

Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)

SARS-CoV-2 Antigen Self Test Nasal

Manufacturer: SD Biosensor Inc (Korea – Republic of)

TESTSEALABS COVID-19 Antigen Test Cassette

Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)

V-Chek COVID-19 Antigen Saliva Test

Manufacturer: Guangzhou Decheng Biotechnology Co Ltd (China)