News, Culture & Society

Therapeutic Goods Administration approves 18 rapid antigen tests but most are sold out

Six of the 18 rapid antigen test products approved for sale in Australia are rated 95 per cent accurate at detecting Covid – but 12 of them are made in China.

The Therapeutic Goods Administration-approved kits have taken on critical importance as the Omicron surge overwhelms coronavirus testing centres.

With Covid cases soaring in the tens of thousands every day in most states, Australians will no longer need to wait for hours queuing up for a PCR swab test in a laboratory.

Instead, they will be able to rely on a home test kit, priced from $12 individually, or cheaper if bought in bulk, to confirm a positive test result for the virus under relaxed National Cabinet rules announced on Wednesday.  

But rapid antigen kits quickly sell out at chemists and supermarkets and new price gouging fines of $66,000 coming into force on Saturday to stop profiteering.

The federal government has approved 18 rapid antigen tests kits with two-thirds of them made in China as an Omicron surge threatens to overwhelm Covid testing centres (pictured is registered nurse Niamh Costello demonstrating a rapid antigen test kit in Sydney)

But rapid antigen kits have sold out with new price gouging fines of $66,000 coming into force on Saturday morning (pictured is a Sydney chemist)

But rapid antigen kits have sold out with new price gouging fines of $66,000 coming into force on Saturday morning (pictured is a Sydney chemist)

Where rapid antigen kits come from

CHINA: 12 out of 18 including six with a ‘very high’ 95 per cent clinical sensitivity

US: two out of 18 including one with ‘very high’ clinical sensitivity

AUSTRALIA: one out of 18 with an ‘acceptable’ clinical sensitivity

GERMANY: one out of 18 with a ‘very high’ clinical sensitivity

SINGAPORE: one out of 18 with a ‘very high’ clinical sensitivity

SOUTH KOREA: one out of 18 with an ‘acceptable’ clinical sensitivity

Chemists aren’t the only ones selling rapid antigen tests with Woolworths, Dick Smith Electronics and Costco also selling kits from China.  

The TGA, an agency of the Department of Health, has approved 18 products since October with 12 of them made in China. 

Only one of the kits was made in Australia with the others coming from the US, Germany, Singapore, and South Korea.

From 1am on January 8, retailers who price gouge on rapid antigen tests will be liable for a fine of up to $66,000 or five years’ jail, with the Australian Competition and Consumer Commission investigating profiteers.

With queues now forming outside chemists instead of Covid testing centres, Health Minister Greg Hunt said the government had bought another 70 million rapid antigen tests, which would take Australia’s total to 200 million.

‘There’s a short-term challenge around the rapid antigen supply,’ he told Seven’s Sunrise program on Thursday.

Prime Minister Scott Morrison admitted the states and territories would be relying on PCR laboratory tests for at least the next fortnight with rapid antigen tests in short supply.

‘Given the supply issues over the next two weeks, that’s what I would expect to occur in the majority of cases,’ he said.

‘But that gives the states a couple of weeks to get this other system in place, and that’s what I anticipate that would occur.’

Here’s Daily Mail Australia’s guide to all 18 tests and which ones are the most accurate, cheapest, and where they come from. 

With queues now forming outside chemists instead of Covid testing centres, Health Minister Greg Hunt said the government had bought another 70million rapid antigen tests, which would take Australia's total to 200million

 With queues now forming outside chemists instead of Covid testing centres, Health Minister Greg Hunt said the government had bought another 70million rapid antigen tests, which would take Australia’s total to 200million

Very high – 95 per cent sensitivity 

The most effective home kits are deemed to have a 95 per cent or ‘very high’ clinical sensitivity rating.

Almost all require an uncomfortable nasal swab test within seven days of someone being symptomatic of the virus.

Of this category, three of the six are made in China with the rest coming from the US, Germany and Singapore.

The Chinese-made All Test rapid antigen tests are selling for $12 at Priceline with nasal kits listed on their website but sold out.

Dick Smith, now an online electronics store selling health products, is selling a 10-pack of LYTHER nasal antigen test kits, also made in China, for $109.

The store is selling a Chinese-made 20-pack of V-Chek saliva test kits for $249, making it the only ‘very high’ rated kit that doesn’t require a nasal swab.

A 20-pack of the US-made Onsite nasal swab kit is available online at the CPAP Clinic for $169. 

A 25-pack box of the German-made Panbio test is available online via McFarlane Medical for $339.75. 

A Singapore-made Biomedicals rapid antigen test is yet to be sent to retailers. 

The most effective home kits, deemed to have a 95 per cent or 'very high' clinical sensitivity rating, almost all require an uncomfortable nasal swab test within seven days of someone being symptomatic of the virus. Dick Smith, now an online electronics store selling health products, is selling a 10-pack of LYTHER nasal antigen test kits, also made in China, for $109. The retailer is selling a Chinese-made 20-pack of V-Chek saliva test kits for $249

The most effective home kits, deemed to have a 95 per cent or ‘very high’ clinical sensitivity rating, almost all require an uncomfortable nasal swab test within seven days of someone being symptomatic of the virus. Dick Smith, now an online electronics store selling health products, is selling a 10-pack of LYTHER nasal antigen test kits, also made in China, for $109. The retailer is selling a Chinese-made 20-pack of V-Chek saliva test kits for $249

High – 90 per cent sensitivity 

On the list of 18 rapid antigen tests, all eight of the ‘high sensitivity’ kits, with a 90 per cent clinical sensitivity rating, are made in China.

A RightSign Covid-19 Antigen Rapid Test, as a nasal swab, is listed at Chemist Warehouse for $24.99 as a two-pack and $49.99 as a five pack.

Both products are out of stock, which means consumers have to place an order online to reserve a delivery.

Workplaces wanting to go bulk testing can buy a 480-pack of Chinese-made JusChek nasal test kits for $5,984, or $12.40 each, from Onsite Drug Testing and Training

Workplaces wanting to go bulk testing can buy a 480-pack of Chinese-made JusChek nasal test kits for $5,984, or $12.40 each, from Onsite Drug Testing and Training

Priceline is listing online an oral swab All Test kit for $12 but it is sold out.

It has also sold out of Orawell saliva test kits retailing for $14.99, another item out of stock.

Woolworths is selling a five-pack of the Chinese-made Hough Pharma for $50.

Costco is selling TESTSEALABS nasal swab kits from China for $154.99 in a pack of 20.

Workplaces wanting to go bulk testing can buy a 480-pack of Chinese-made JusChek nasal test kits for $5,984, or $12.40 each, from Onsite Drug Testing and Training.

The oral version of the same product is yet to be listed for sale in Australia.

The Chinese-made My Covid Test Antigen Rapid Test, supplied by AM Diagnostics, is meant to be available at Woolworths in NSW, Victoria, and Queensland.

But the supermarket giant has yet to list this oral test kit on its website.

On the list of 18 rapid antigen tests, all eight of the 'high sensitivity' kits, with a 90 per cent clinical sensitivity rating, are made in China. A RightSign COVID-19 Antigen Rapid Test, as a nasal swab, is listed at Chemist Warehouse for $24.99 as a two-pack and $49.99 as a five pack

 On the list of 18 rapid antigen tests, all eight of the ‘high sensitivity’ kits, with a 90 per cent clinical sensitivity rating, are made in China. A RightSign COVID-19 Antigen Rapid Test, as a nasal swab, is listed at Chemist Warehouse for $24.99 as a two-pack and $49.99 as a five pack

Acceptable – 80 per cent sensitivity 

Only one rapid antigen test kit is made in Australia but the InnoScreen COVID-19 Antigen Rapid Test Device, manufactured by Innovation Scientific, only has an ‘acceptable’ sensitivity rating of 80 per cent.

But this kit is only, so far, available at a wholesale level with AusHealth Work taking orders on behalf of pharmacies. 

A Korean-made nasal swab kit, manufactured by SD Biosensor for Roche Diagnostics is available at Blooms The Chemist online as a five-pack for $59.99.

Blooms is also selling a Chinese-made Ecotest saliva kit for $25.99 as a two-pack.

The American-made CareStart nasal swab is yet to go on sale in Australia. 

Nasal kits dominate 

Nasal test kits make up 12 of the 18 rapid antigen tests, compared with three for the saliva test options and three for an oral fluid swab requiring a cotton bud at the back of the throat. 

The TGA performance guidelines are aligned with World Health Organisation and European Commission specifications.  

Priceline is listing online an oral swab All Test kit but it is sold out. It has also sold out of Orawell saliva test kits (pictured) retailing for $14.99

Priceline is listing online an oral swab All Test kit but it is sold out. It has also sold out of Orawell saliva test kits (pictured) retailing for $14.99

Mr Morrison this week announced all concession card holders – more than six million Australians – will be given access to 10 free rapid antigen tests.

The decision was made after an emergency National Cabinet meeting on Wednesday.

All Australians who are deemed close contacts or who have symptoms will still be able to access free rapid tests from testing clinics.

The Commonwealth will provide 10 million rapid antigen tests to be distributed throughout the states and territories for eligible Aussies.

To access the tests, which is capped at five per month, a recipient will require identification in the same way people need to prove their identity to access certain prescription drugs.

The 18 rapid antigen test kits approved in Australia

VERY HIGH SENSITIVITY – 95 PER CENT CLIINCAL SENSITIVITY

Nasal swab kit: All Test SARS-CoV2 Antigen Rapid Test made in China by Hangzhou Alltest Biotech Co; supplier: AM Diagnostics

Nasal swab kit: LYHER Novel Coronavirus (Covid-19) Antigen Test Kit colloidal gold made in China by Hangzhou Laihe Biotech; supplier: 2San 

Nasal swab kit: OnSite COVID-19 Ag Self Test made in the United States by CTK Biotech; supplier: MD Solutions Australasia

Nasal swab kit: Panbio COVID-19 Antigen Self-Test made in Germany by Abbott Rapid Diagnostics Jena GmbH; supplier: Abbott Rapid Diagnostics

Nasal swab kit: Rapid SARS-Cov-2 Antigen Test Card Self-test made in Singapore by MP Biomedicals Asia Pacific; supplier: MP Biomedicals Australasia

Saliva test kit: V-Chek COVID-19 Antigen Saliva Test made in China by Guangzhou Decheng Biotechnology Co; supplier: Cole Workwear

HIGH SENSITIVITY – 90 PER CENT CLINICAL SENSITIVITY

Oral fluid kit: All Test COVID-19 Antigen Rapid Test made in China by Hangzhou Alltest Biotech Co; supplier: AM Diagnostics

Nasal swab kit: Hough COVID-19 Home Test made in China by BIOHIT HealthCare (Hefei) Co; supplier: Hough Pharma

Nasal swab kit: JusChek SARS-Cov-2 Antigen Rapid Test made in China by Hangzhou Alltest Biotech: supplier: Compliance Management Solutions 

Oral fluid kit: JusChek COVID-19 Antigen Rapid Test made in China by Hangzhou Alltest Biotech; supplier Compliance Management Solutions 

Oral fluid kit: My Covid Test Antigen Rapid Test made in China by Hangzhou Alltest Biotech; supplier: AM Diagnostics 

Saliva test kit: Orawell COVID-19 Ag Rapid saliva test device made in China by Jiangsu Well Biotech; supplier: Motion One

Nasal swab kit: RightSign COVID-19 Antigen Rapid Test Cassette made in China by Hangzhou Biotest Biotech Co; supplier: MedSupply Australia

Nasal swab kit: TESTSEALABS COVID-19 Antigen Test Cassette made in China by Hangzhou Testsea Biotechnology; supplier: Pharma Soul

ACCEPTABLE SENSITIVITY – 80 PER CENT CLINICAL SENSITIVITY

Nasal swab kit: CareStart COVID-19 Antigen Home Test made in the United States by Access Bio Inc; supplier: Pantonic

Saliva test kit: Ecotest COVID-19 Antigen Saliva Test made in China by Assure Tech (Hangzhou) Co; supplier: Emergence Technology

Nasal swab kit: InnoScreen COVID-19 Antigen Rapid Test Device made in Australia by Innovation Scientific; supplier: Innovation Scientific 

Nasal swab kit: SARS-CovV-2 Antigen Self Test Nasal made in South Korea by SD Biosensor; supplier: Roche Diagnostics

***
Read more at DailyMail.co.uk