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FDA grants EUA status for Vela Diagnostics’ Zika Virus molecular assay

MDBR Staff Writer Published 27 September 2016

Singapore-based Vela Diagnostics has secured emergency use authorization (EUA) status from the US Food and Drug Administration for its Sentosa SA ZIKV RT-PCR test.

The new real-time PCR test has been developed for the qualitative detection of RNA from Zika virus in human specimens.

Vela will offer Zika virus molecular assay for the US laboratories, which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and similarly qualified non-US laboratories.

The new test will run on the automated Sentosa SX101 real-time PCR workflow, in addition to Sentosa SX Virus Total Nucleic Acid Kit v2.0.

It will allow to process 22 samples per run for rapid detection of Zika virus with a turn-around time of about three hours.

According to the company, the test is authorized for use with serum, EDTA plasma, and urine collected from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria or epidemiological criteria.

In addition, the test is authorized only to detect RNA from Zika virus and diagnosis of Zika virus infection, and not for any other viruses or pathogens

In August, the firm also received CE mark approval for Sentosa SA ZIKV PCR test. It 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 provides 25 CE-IVD approved PCR tests and 5 CE-IVD approved NGS panels validated with 19 different sample types and open-channel capabilities.