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Cell-free DNA kit receives CE-IVD mark


 

Photo by Juan D. Alfonso

Blood sample collection

Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.

The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.

The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.

The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.

Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.

The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.

Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.

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