Vela Dx Zika Assay Receives CE Mark
News Aug 19, 2016
Vela Diagnostics has announced that the real-time PCR based Sentosa® SA ZIKV PCR Test is now CE marked for in-vitro diagnostic use. The test is an addition to Vela Diagnostics’ tropical infections portfolio, which currently features a dengue and chikungunya real-time PCR test. The Sentosa® SA ZIKV 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.
The real-time 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 PCR Test has a high analytical performance with 82 zika virus strains detected and no cross-reactivity with 44 pathogens including dengue and chikungunya.
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. The zika test runs on the automated Sentosa workflow and can be combined with Vela Diagnostics’ Dengue and Chikungunya tests in order to give customers a differentiation amongst the hemorrhagic fevers relevant to identify for an accurate patient treatment with a fast turn-around time.
Vela Diagnostics offers automated PCR and NGS system solutions for virology and oncology. Currently Vela Diagnostics offers 25 CE-IVD approved PCR tests and 5 CE-IVD approved NGS panels validated with 19 different sample types and open-channel capabilities.