16 April 2020 | News
Singapore Health Sciences Authority approves the ViroKey™ SARS-CoV-2 RT-PCR Test via provisional authorisation
image courtesy: Clinical Lab Products
Vela Diagnostics has announced that the ViroKey™ SARS-CoV-2 RT-PCR Test has received provisional authorisation from the Health Sciences Authority in Singapore. This allows the test to be supplied to healthcare institutions, private hospitals, medical clinics and clinical laboratories licensed under the Private Hospitals and Medical Clinics (PHMC) Act in Singapore.
SARS-CoV-2 causes COVID-19. The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments. For high throughput testing, Vela Diagnostics has also developed a research use only (RUO) automated version of the test which is optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx.
"Timely detection of individuals infected with SARS-CoV-2 will save lives and curb the spread of the virus in this global pandemic," said Sam Dajani, Acting CEO and Chairman of the Board.
The test is also pending CE marking.