Dodgy COVID-19 rapid test kits should be immediately banned: SA-BEST

30 April 2020

Some COVID-19 rapid test kits flooding the market in Australia are unreliable and should be immediately banned, SA-BEST warned today. 

SA-BEST MLC and Ageing spokesperson, Frank Pangallo, revealed today some of the kits being sold throughout Australia – although approved by the Therapeutic Goods Administration – are producing grossly inaccurate results. 

In some cases, results are ranging from between 5.4 per cent to 70 per cent accuracy – despite claims by the manufacturer of an accuracy rate of 95 per cent. 

“As a matter of urgency, the State Government must determine if any of these dodgy kits are being sold and used in South Australia and if so, immediately ban them from sale,” Frank said. 

“The government must also determine who has bought them, and advise them that they should re-test themselves,” he said. 

“I am not trying to be alarmist here, and I would hope most of the test kits available are to standard and fit for purpose.

 “However, in its rush to allow more tests to be carried out, the Therapeutic Goods Administration has given approval to at least 29 point-of-care test (POCT) kits - many made by Chinese manufacturers out to cash in on the pandemic. 

“These kits supposedly allow doctors to rapidly screen patients for the virus within minutes via a blood test. 

“I have been made aware that these POCT kits can produce widely inaccurate results - from between 5.4% to 70% accuracy – meaning people’s health are potentially at risk.” 

“A false reading could result in the virus being spread unintentionally.” 

Frank said one Australian company using the test kits was already under investigation. 

He also has been informed several companies listed on the TGA's register did not have approved manufacturing and export status and neither were they listed on the official Chinese Government register. 

“India has just stopped the use of defective effective test kits from two companies on that register -Wondofo Biotech and Zhuhai Livzon Diagnostics,” Frank said. 

“Further, the World Health Organisation has suggested - based on current evidence - that the use of these new point-of-care diagnostic tests only be used in research settings,” he said. 

“It has warned they should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available. 

“As scientific researchers in the US have warned, it’s a ‘Wild West’ out there with these unproven tests.”

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