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Vela Diagnostics gets CE mark approval for Zika Virus real-time PCR assay

Published 19 August 2016

Singapore-based Vela Diagnostics has received CE mark approval for its Zika Virus real-time PCR assay.

Sentosa SA ZIKV PCR test, which was approved for in-vitro diagnostic use, expands the firm’s tropical infections portfolio that currently includes dengue and chikungunya real-time PCR tests.

The new test has been developed for identification and differentiation of zika virus in patients suspected to suffer from zika virus infections and validated for plasma, serum or urine samples.

With a capacity to detect samples with low zika viral load, the test is having 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.

According to the company, the test has a high analytical performance with 82 zika virus strains detected and no cross-reactivity with 44 pathogens including dengue and chikungunya.

The company has designed the new test to run on the automated Sentosa real-time PCR workflow, as well as Sentosa SX Virus Total Nucleic Acid Kit v2.0.

It holds capacity to process around 22 samples per run for rapid detection of zika virus with a turn-around time of about three hours.

The zika test can also be combined with the firm’s Dengue and Chikungunya tests to differentiate the hemorrhagic fevers, helping to provide an accurate treatment for the patients.

Vela provides automated PCR and NGS system solutions for virology and oncology. It currently offers 25 CE-IVD approved PCR tests and 5 CE-IVD approved NGS panels validated with 19 different sample types and open-channel capabilities.