PAXgene Blood ccfDNA Tube (100)

Designed by QIAGEN for research use only, the PAXgene Blood ccfDNA Tube is a sterile, plastic, closed, evacuated blood collection tube intended for the collection, anticoagulation, transportation, and storage of human whole blood specimens and the stabilization of circulating cell-free DNA (ccfDNA) and genomic DNA (gDNA). It contains a 1.5 mL cell stabilization additive that is free of formaldehyde and formaldehyde-releasing substances, with a 10.0 mL draw volume in a 16 × 100 mm tube. The tube features a safety-engineered BD Hemogard closure with a blue stopper and pearlescent shield.

Blood is collected using standard venipuncture technique, and the filled tube is gently inverted 8 times after collection to mix the blood with the additive. The non-cross-linking stabilization solution anticoagulates the blood and stabilizes blood cells, helping to prevent the release of intracellular DNA into the plasma and to stabilize ccfDNA levels. ccfDNA remains stable in whole blood for up to 10 days at temperatures up to 25°C, for 7 days at temperatures up to 30°C, or for 3 days at temperatures up to 37°C. Plasma is prepared by centrifugation at room temperature (15–25°C) for 15 minutes at 1600–3000 × g. High-quality ccfDNA can be isolated from the plasma using the QIAsymphony PAXgene Blood ccfDNA Kit, the QIAamp Circulating Nucleic Acid Kit, QIAamp MinElute ccfDNA Kits, or EZ1 ccfDNA Kits. After plasma removal, gDNA can be isolated from the remaining buffy coat or nucleated cellular fraction. Direct sampling of the plasma from the tube on the QIAsymphony SP is possible to reduce the risk of sample mix-up, processing time, and material costs.

The product was developed in accordance with the European Committee for Standardization standard ISO 20186-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Performance characteristics were established in studies in which ccfDNA and gDNA were purified from human plasma and the cellular fraction; users must validate the performance of the system in their laboratory for specific research applications. A 3-month minimum shelf life is guaranteed upon delivery.