Liquid biopsy analyses based on circulating cell-free DNA in blood offer new means for non-invasive diagnostic applications. The pre-analytical workflow, however, from blood collection through to purified ccfDNA includes many challenges. It is estimated that the pre-analytical phase accounts for most of the testing errors observed in this workflow. A big challenge is to ensure ccfDNA profile stability during transportation and storage until the plasma is generated by blood centrifugation. 

Apoptosis of white blood cells can lead to release of cellular nucleic acids (gDNA), which dilutes the target ccfDNA, potentially resulting in false negative diagnostic test results. Stabilization solutions based on crosslinking reagents can lead to DNA modification. When it comes to purification, ccfDNA is usually of low concentrations in plasma and highly fragmented. In order to achieve sufficient yield, a large volume of plasma needs to be processed. 

In this webinar, we present the integrated, standardized automated workflow solution from PreAnalytiX for medium-to-high-throughput ccfDNA from plasma. This consists of the PAXgene Blood ccfDNA Tube (CE-IVD), the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and dedicated protocols. All components of the workflow are validated according to the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). Primary tube handling protocols allow direct processing from the PAXgene Blood ccfDNA Tube. This eliminates the need to transfer the plasma sample into a secondary tube which reduces risk for exposure and sample mix-up, costs and biohazardous waste. 

*CE-IVD is CE marked for in vitro diagnostic use according to the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).