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Vela Diagnostics Quantitative Hepatitis B Test Gets CE-IVD Mark

NEW YORK (GenomeWeb) – A qPCR-based assay to detect Hepatitis B virus DNA from Vela Diagnostics has received CE-IVD approval.

The Sentosa SA HBV Quantitative PCR Test runs on Vela's automated Sentosa workflow. This workflow has been designed to drive cost efficient automation into medium throughput laboratories, and, according to the firm's website, includes: the Sentosa SX101 automated pipetting system for sample lysis, nucleic acid extraction, and PCR set-up as well as NGS library prep; the Qiagen Rotor-Gene QM Dx 5plex HRM Platform for rapid thermal cycling; and the Sentosa SA Reporter and SQ Reporter software to automatically analyze results.

The HBV test is for use on human plasma and serum and can detect HBV genotypes A through J. The test has a dynamic range of 12 IU per ml to 3.75 x 107 IU per ml, the firm said in a statement. It is now part of a portfolio of 30 infectious disease and oncology tests for the Sentosa workflow, including PCR tests for respiratory viruses, tropical infections, herpes and polyomaviruses, and oncology assays, as well as next-generation sequencing-based tests and panels in the oncology and virology space.