AsianScientist (Sep. 29, 2016) – On Monday, Singapore-based molecular diagnostics firm Vela Diagnostics announced that it has received Emergency Use Authorization from the US Food and Drug Administration for its Zika virus molecular assay.
The Sentosa® SA ZIKV RT-PCR Test, which was developed and manufactured in Singapore, received the European CE mark for in vitro diagnostic use in August 2016.
The real-time test enables the qualitative detection of RNA from Zika virus in human specimens, and is available for use in certain certified laboratories in the US to perform high complexity tests, or by similarly qualified non-US laboratories.
The test is authorized for use on plasma, serum and urine samples from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and/or epidemiological criteria. All three sample types can be processed in the same run, and fully automated sample extraction to report output can be carried out in under three hours.
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Source: Vela Diagnostics.
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