Vela Diagnostics’ Zika Virus Real-Time RT-PCR Assay Receives Singapore HSA Approval for in-vitro diagnostic use

Singapore (February 07, 2018) – Vela Diagnostics announced today that the Real-Time PCR-based Sentosa®  SA ZIKV RT-PCR Test is now approved by the Singapore Health Sciences Authority for in-vitro diagnostic use.  The panel has also attained CE-IVD status in August, 2016 and received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration in September, 2016.

According to the National Environment Agency the latest Zika case was reported on 18-January, which is the first case in Singapore since September 2017. In August 2016 some 450 cases were reported by the end of that year following the first case of locally transmitted Zika in Singapore.

The real-time RT-PCR test by Vela Diagnostics enables detection of samples with low Zika viral load. The 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 RT-PCR Test has a high analytical performance with 82 Zika virus strains detected and no cross-reactivity with 44 pathogens. The Sentosa® SA ZIKV RT-PCR Test is approved for identification and differentiation of Zika virus in patients suspected to suffer from Zika virus infections and validated for plasma, serum or urine samples.

Designed to run 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 with a turn-around time of approximately 3 hours.