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PAXgene Blood ccfDNA Tube (CE-IVD)

For collection of whole blood samples and stabilization of ccfDNA

 

  • CE Mark for In Vitro Diagnostic use
  • Single-tube collection, stabilization, transport and storage
  • Stabilization of circulating, cell-free DNA (ccfDNA)
  • Sample transport and storage up to 7 days at 2–30°C and 1 day at 37°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 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.

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Cat No./ID: 768165
PAXgene Blood ccfDNA Tubes (CE-IVD)
100 blood collection tubes (10 ml). This product is sold by BD. Clicking inquire will take you to BD Customer Care.

The PAXgene Blood ccfDNA Tube (CE-IVD) is intended for in vitro diagnostic use.


Product Details

Performance

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 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"). ccfDNA levels are stable for up to 7 days at 2–30°C or up to 1 day at 37°C, so 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").

Principle
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 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 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.
Procedure

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 an evacuated tube that contains a proprietary ccfDNA stabilization additive. After collection, the whole blood sample can be stored for up to 7 days at 2–30°C or 1 day at 37°C prior to processing. After tube centrifugation, ccfDNA isolation from plasma is carried out using manual or automated methods that are 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 methods that are based on magnetic bead or silica-membrane technologies.

Applications

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

 

 

Specifications

Features
Specifications
Additive/concentration Additive 1.5 ml
Closure type/color Pearl white BD Hemogard/Blue stopper
Draw volume 10 ml
Label type Paper
Quantity 100 tubes/case
Stabilization Up to 7 days at room temperature (15–25°C) Up to 24 hours at 35°C
Tube size 16 x 100 mm

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