PAXgene Blood ccfDNA Tube (CE-IVD)

For collection of whole blood samples and stabilization of circulating cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from the nucleated cellular fraction

Features

 

  • CE Marked (CE 0123) For In Vitro Diagnostic Use*
  • Single tube collection, stabilization, transport and storage
  • Formaldehyde-free, non-crosslinking stabilization of circulating, cell-free DNA (ccfDNA)
  • Stabilization of ccfDNA in plasma and genomic DNA (gDNA) in the nuclear cellular fraction for days at various temperatures facilitates transport and storage
  • Barcode with tube ID, lot number, expiration date and unique serial number
  • Direct processing of plasma within primary blood collection tube after one centrifugation step on QIAsymphony SP instrument

*According to EU Regulations on in vitro diagnostic medical devices (REGULATION (EU) 2017/746), every component of ccfDNA workflow compliant to IVD.

PAXgene Blood ccfDNA Tube (IVD) and QIAsymphony PAXgene Blood ccfDNA Kit (IVD) are not available in the US.

PAXgene Blood ccfDNA Tubes (CE-IVD)

Cat. No. / ID: 768165

100 blood collection tubes (10 ml). This product is sold by BD. Clicking inquire will take you to BD Customer Care.
PAXgene Blood ccfDNA Tube (IVD) and QIAsymphony PAXgene Blood ccfDNA Kit (IVD) are not available in the US.
The PAXgene Blood ccfDNA Tube (CE-IVD) is intended for in vitro diagnostic use.

Product Details


The PAXgene Blood ccfDNA Tube (CE-IVD) is intended for the collection, storage, and transport of human venous whole blood and stabilization of DNA for preparation of circulating, cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from the nucleated cellular fraction.

Performance

PAXgene Blood ccfDNA Tubes (CE-IVD) simplify the collection and processing of whole blood for subsequent purification of circulating, cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from the nucleated cellular fraction. The tube additive is non-crosslinking, free of formaldehyde-releasing substances, stabilizes blood cells and prevents prevent apoptosis.

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").

Plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) can be used to process ccfDNA automated with the PreAnalytiX QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) or the QIAGEN QIAamp DSP Circulating Nucleic Acid Kit. The nucleated cellular fraction or buffy coat remaining after removal of the plasma can be processed for gDNA automated with the QIAGEN QIAsymphony DSP DNA Mini and Midi Kits or manually with the QIAGEN QIAamp DSP DNA Blood Mini Kit (See "Figure 2").

ccfDNA yields from plasma processed from blood collected into PAXgene Blood ccfDNA Tubes are similar to plasma from EDTA tube separated directly after blood draw (See "Figure 3"). But in contrast to unstabilized EDTA, within blood drawn into PAXgene Blood ccfDNA Tubes ccfDNA levels are stable for 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 (Note: Do not store blood-filled tubes below 2°C), because DNA release from lysing or apoptotic cells is prevented (See "Figure 4") and ccfDNA is preserved (See "Figure 5"). Genomic DNA in the nucleated cellular fraction is preserved and can be isolated with high purity, yield and integrity (See "Figure 6"). Thus, blood samples can be transported and stored within the specified temperature and duration to process plasma later (see technical note ´Sample Transportation Study (Summer Profile)´).

Plasma and nucleated cellular fraction generated from whole blood collected into PAXgene Blood ccfDNA Tubes are stable at room temperature for at least 3 days, at refrigerated temperature for at least 7 days and can be stored for long-term frozen at -20°C or -80°C (for latest update see technical note ´Plasma and Nucleated Cellular Fraction Stability Study´).

Pre-analytical steps including handling, storage, processing and documentation of verification and validation studies of PAXgene Blood ccfDNA Tube were conducted in accordance with ISO 20186-2:2019 and ISO 20186-3:2019: Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA and — Part 3: Isolated circulating cell free DNA from plasma. Stabilization characteristics have been shown to be robust against elevated level of endogenous, potentially interfering substances, underfilling and inappropriate mixing (see technical note ´ Tube Robustness Study´ ).

Both ccfDNA and gDNA yields are high-quality and can be used for downstream analytical assays, including but not limited to PCR-based assays, methylation assays, and next-generation sequencing (NGS) (See "Figure 7").

 

See figures

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 subsequent stabilization of ccfDNA from plasma and genomic DNA from the 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.

Procedure

(for details, see PAXgene Blood ccfDNA Tube (CE-IVD) Instructions for User)

Blood is collected under a standard phlebotomy protocol into a closed, evacuated tube that contains a proprietary ccfDNA stabilization additive.

Whole blood sample can be stored 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.

Centrifugation of blood collected into a PAXgene Blood ccfDNA Tube at room temperature (15–25°C) for 15 minutes at 1,600–3,000 × g leads to separation of plasma and nucleated cellular fraction. The nucleated cellular fraction includes a buffy coat, a leukocyte and platelet rich layer, and a red blood cell fraction. Plasma is removed after the first centrifugation into a secondary tube. For ccfDNA isolation the plasma is centrifuged again for 10 minutes at 1,600–3,000 × g. As an alternative after a first centrifugation for 15 minutes at 3,000 × g, the tube can be directly placed on the QIAGEN QIAsymphony SP instrument for automated ccfDNA extraction using the primary tube handling protocol of the QIAsymphony PAXgene Blood ccfDNA Kit (See "Figure 8").

After removal of the plasma, the remaining nucleated cellular fraction can be used to isolate gDNA.

Applications

ccfDNA purified from plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) and purified using the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) or QIAamp DSP Circulating NA Kit can be used in a wide range of downstream applications, including:

  • PCR, including digital, multiplex and quantitative real-time PCR
  • Pharmacogenomic studies
  • SNP genotyping
  • Next-generation sequencing
  • Methylation assays

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

 

Supporting data and figures

Specifications

FeaturesSpecifications
Closure type/colorPearl white BD Hemogard/Blue stopper
Label typePaper
Tube size16 x 100 mm
Stabilization2–37°C for up to 3 days 2–30°C for up to 7 days 2–25°C for up to 10 days Do not store blood-filled tubes below 2°C.
Draw volume10 ml
Quantity100 tubes/case
Additive/concentrationAdditive 1.5 ml
Shelf life15 months from date of manufacture
Fractions isolatedccfDNA isolation from plasma: Automated with the PreAnalytiX QIAsymphony PAXgene Blood ccfDNA Kit using the QIAGEN® QIAsymphony® SP instrument (including primary tube handling). Manual with the QIAGEN QIAamp® DSP Circulating Nucleic Acid Kit. gDNA isolation from nucleated cellular fraction or buffy coat: Automated with the QIAGEN QIAsymphony DSP DNA Mini and Midi Kits using the QIAsymphony SP instrument. Manual with the QIAGEN QIAamp DSP DNA Blood Mini Kit.

Resources

White Papers (1)

Guidance documentation for user evaluation of blood collection tubes for ccfDNA applications

Kit Handbooks (External Websites) (1)

Download the PAXgene Blood ccfDNA Tube CE-IVD Product Circular from the BD website at www.bd.com/IFU

Brochures & Guides (1)
For stabilization of ccfDNA from whole blood