Vela Diagnostics has announced that its real-time PCR based Sentosa SA ZIKV PCR Test has secured CE mark for in-vitro diagnostic use.
Vela Diagnostics’ tropical infections portfolio consists of a dengue and chikungunya real-time PCR test.
Approved for identification and differentiation of zika virus in patients suspected to suffer from zika virus infections, Sentosa SA ZIKV PCR Test is validated for plasma, serum or urine samples.
The real-time PCR test allows detection of samples with low zika viral load.
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 comes with a high-analytical performance with 82 zika virus strains detected and 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.
Vela Diagnostics provides automated PCR and NGS system solutions for virology and oncology.
The firm currently provides 25 CE-IVD approved PCR tests and 5 CE-IVD approved NGS panels validated with 19 different sample types and open-channel capabilities.