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AusDiagnostics SARS-CoV-2 panel now included in the Australian Register of Therapeutic Goods and receives CE marking

AusDiagnostics has included its dual target SARS-CoV-2, Influenza and RSV panel in the Australian Register of Therapeutic Goods. It has also been CE marked.  

The panel achieved 100 per cent sensitivity and 100 per cent specificity in a study of 210 samples including 44 from COVID-19 patients. The work was carried out by scientists at Sydney’s Westmead Hospital and presented to the Therapeutic Goods Administration last week. 

The panel has two targets for SARS-CoV-2, one in ORF 1a and one in ORF 8. Using two targets makes the test more robust if mutations in the virus occur. The other targets in the panel detect respiratory illnesses with similar symptoms. 

In the study of 210 samples 13 turned out to be either Influenza or Respiratory Syncytial Virus. 

The multiplexed tandem PCR technology used by AusDiagnostics allows a low limit of detection to be achieved with clinical samples. Some samples could be diluted 1,000,000 fold and still were successfully detected. 

“Versions of the product are available for both the 24 sample High-Plex and 96 sample Ultra-Plex instruments that are manufactured by AusDiagnostics and are available immediately,” said AusDiagnostics Managing Director Professor Keith Stanley.  

The number of COVID-19 cases in Australia has surpassed 1600. Globally, infections have risen above 335,000 and more than 14,500 people have died.