TBG Diagnostics Limited’s (ASX:TDL) wholly-owned subsidiary TBG Biotechnology Corp. (TBG Taiwan) has received an Emergency Use Authorisation (EUA) from the Taiwan Ministry of Health and Welfare “MOHW) for its ExProbe SARS-CoV-2 Testing Kit.
The ExProbe SARS-CoV-2 Testing Kit is an RNA based diagnostic kit that uses real time PCR technology with multiplex design to detect distinctive segments within RdRP, N and E genes of the SARS-CoV-2 virus in a single reaction.
Chairman, Jitto Arulampalam, said the kit is commonly used to confirm active infection of the SARS-CoV-2 virus from a specified range of upper and lower respiratory samples. This test is manufactured by TBG Biotechnology Corp. in Taiwan.
The Taiwan MOHW has made the Testing Kit available under an emergency access mechanism called an EUA. The EUA is supported by the Taiwan MOHW that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
Since the Testing Kit is made available under an EUA, it has not undergone the same type of review as an FDA-approved or cleared IVD.
The EUA for the Testing Kit is in effect from July 24th, 2020 until December 31st, 2021.
The Testing Kit is one of 10 in vitro diagnostics nucleic acid test kits for detection and/or diagnosis of the novel coronavirus which have received Taiwan EUAs to date.