Vela Diagnostics gets FDA emergency use authorisation for Sentosa SA ZIKV PCR Test

26 September 2016 (Last Updated September 26th, 2016 18:30)

Vela Diagnostics has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Sentosa SA ZIKV PCR Test.

Vela Diagnostics has obtained Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Sentosa SA ZIKV PCR Test.

The real-time PCR test can qualitatively detect RNA from Zika virus by examining specimens such as serum, Ethylenediaminetetraacetic acid (EDTA) plasma, and urine derived from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and / or epidemiological criteria.

The real-time PCR test allows detection of samples with low zika viral load.

"The zika test runs on the automated Sentosa workflow and then can be combined with Vela Diagnostics’ dengue and chikungunya tests."

This test has a limit of detection of 3 x 10³ copies/mL for ZIKV PRAVBC59 target gene and 6 x 10³ copies/mL for ZIKV MR-766 target gene.

The Sentosa SA ZIKV PCR Test features a high-analytical performance detecting 82 zika virus strains with no cross-reactivity with 44 pathogens including dengue and chikungunya.

Intended to operate on the automated Sentosa real-time PCR workflow, along with the Sentosa SX Virus Total Nucleic Acid Kit v2.0, laboratories can process 22 samples per run for rapid detection of zika virus and has a turn-around time of around three hours.

The zika test runs on the automated Sentosa workflow and then can be combined with Vela Diagnostics’ dengue and chikungunya tests.

This provides a differentiation amongst the hemorrhagic fevers in order to identify an accurate patient treatment with a fast turn-around time.

Recently, the Sentosa SA ZIKV PCR Test has also obtained CE mark for in-vitro diagnostic use.