PAXgene Blood ccfDNA Tube (CE-IVD)

• CE Marked for In Vitro Diagnostic use
• Single tube collection, stabilization, transport and storage
• Formaldehyde-free, non-crosslinking stabilization of circulating cell-free DNA (ccfDNA)
• Sample transport and storage 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
• Standardized preanalytical processing of samples
• Barcode with tube ID, lot number, expiration date and unique serial number

The PAXgene Blood ccfDNA Tube (CE-IVD) is intended for the collection, storage, and transport of human whole blood samples and stabilization of DNA in a closed tube for preparation of circulating, cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from the nucleated cellular fraction for use with molecular test methods that require ccfDNA or gDNA. The performance characteristics for the PAXgene Blood ccfDNA Tube (CE-IVD) have been established with 18S ribosomal and DYS14 Y-chromosome ccfDNA fragments in plasma. Users must validate use of product for their specific molecular diagnostic assay.

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 inhibits 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. 10 days at temperatures of 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.

Plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) and processed with the automated QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) or the QIAamp DSP 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 nucleated cellular fraction. The tube contains an additive that keeps blood from coagulating, 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. Whole blood samples 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 later 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, including digital, multiplex and quantitative real-time PCR and methylation-based assays
• Next-generation sequencing