PAXgene Blood ccfDNA Tube (CE-IVD)

PAXgene Blood ccfDNA Tubes (CE-IVD) simplify the collection and processing of whole blood for subsequent purification of circulating, cell-free DNA (ccfDNA). The tube additive is non-crosslinking, free of formaldehyde-releasing substances, stabilizes blood cells and helps prevent apoptosis. Consequently, using PAXgene Blood ccfDNA Tubes (CE-IVD) for whole blood collection, storage and transport helps prevent the release of intracellular DNA into plasma (see "PAXgene Blood ccfDNA stabilization minimizes hemolysis compared to alternative solutions" and "PAXgene Blood ccfDNA stabilization reagent helps prevent release of gDNA into plasma"). 10 days at temperatures up to 25°C, 7 days at temperatures up to 30°C, or 3 days at temperatures up to 37°C. Do not store blood-filled tubes below 2°C.  Thus, blood samples can be transported and stored at room temperature to process plasma later (see "PAXgene Blood ccfDNA Tubes (CE-IVD) stabilize genomic DNA in buffy coat and nucleated cellular fractions" and "Minimal changes in ccfDNA levels relative to time 0, after storage at various times and temperatures").

Plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) and processed with the automated QIAsymphony PAXgene Blood ccfDNA Kit or the QIAGEN QIAamp Circulating Nucleic Acid Kit yields high-quality ccfDNA for downstream analytical assays, including but not limited to PCR-based assays, methylation assays, and next-generation sequencing (NGS).

The PAXgene Blood ccfDNA Tube (CE-IVD) is a plastic, closed, evacuated tube for the collection, anticoagulation, transport and storage of human whole blood samples, and the subsequent stabilization of ccfDNA from plasma and genomic DNA from the buffy coat or nucleated cellular fraction. The tube contains an additive that anticoagulates blood, stabilizes blood cells and helps prevent apoptosis via a non-crosslinking formaldehyde-free stabilization solution. This helps prevent the release of intracellular DNA into the plasma and maintains constant ccfDNA levels during sample transport and storage before processing.

The PAXgene Blood ccfDNA Tube (CE-IVD) provides a means for the collection of whole blood for the isolation of ccfDNA from plasma and genomic DNA from the buffy coat or nucleated cellular fraction. Blood is collected under a standard phlebotomy protocol into a closed, evacuated tube that contains a proprietary ccfDNA stabilization additive. After collection, the whole blood sample can be stored up to 10 days at temperatures up to 25°C, 7 days at temperatures up to 30°C, or 3 days at temperatures up to 37°C. Do not store blood-filled tubes below 2°C.

After tube centrifugation, ccfDNA isolation from plasma is carried out using manual or automated ccfDNA isolation methods based on magnetic bead or silica-membrane technologies. The remaining buffy coat, a leukocyte and platelet rich layer at the interface of the plasma and red blood cell fractions, can be harvested and used to isolate gDNA using manual or automated DNA isolation methods based on magnetic bead or silica membrane technologies.

ccfDNA purified from plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) can be used in a wide range of downstream applications, including:

• PCR, digital PCR, multiplex and quantitative real-time PCR and methylation-based assays
• Next-generation sequencing