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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 at 2–30°C for up to 7 days and 37°C for up to 1 day
  • Standardized preanalytical processing of samples
  • Barcode with tube ID, lot number and expiration date and unique serial number

Feature

Specification

Tube size

16 x 100 mm

Blood draw volume

10 ml

Additive Volume

1.5 ml

Length of stabilization

  • Up to 7 days at 2–30°C
  • Up to 1 day at 37°C

Closure type/color

Pearl white BD Hemogard/Blue stopper

Quantity

100 tubes/case


Intended Use

The PAXgene Blood ccfDNA Tube (CE-IVD) is intended for the collection, storage, and transport of human blood 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 ccfDNA Tube (CE-IVD) have been established with 18S ribosomal and DYS14 Y-chromosomal ccfDNA fragments in plasma.

Users must validate use of product for their specific molecular diagnostic assay.

Order information

Product

Catalog Nr.

Price

PAXgene Blood ccfDNA Tubes (100) CE-IVD

100 blood collection tubes (10 ml).

768165

Details

Table 1. Comparison PAXgene Blood ccfDNA System (RUO) and PAXgene Blood ccfDNA Tube (CE-IVD)

PAXgene Blood ccfDNA System (RUO)

PAXgene Blood ccfDNA Tube (CE-IVD)

  • Research use only
  • 10 ml blood draw volume
  • Integrated system with collection tube and ccfDNA purification kit
  • Compatible with QIAGEN QIAamp manual ccfDNA purification
  • CE Mark for In Vitro Diagnostic Use
  • 10 ml blood draw volume
  • Can be used with silica membrane and magnetic bead ccfDNA purification methods
  • Compatible with QIAGEN ccfDNA purification kits for manual and automated workflows
  • Same manufacturing processes and site
  • Same tube components and additive
  • Distributed by QIAGEN
  • Distributed by BD
 
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. 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.

Plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) and processed with theQIAsymphony 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, including methylation assays, and next-generation sequencing (NGS).

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 for ccfDNA isolation. The remaining buffy coat, a leukocyte and platelet rich layer at the interface of 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 for DNA isolation.

Applications

ccfDNA purified from plasma generated from whole blood collected in 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
     

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

After blood is collected into the tube, the ccfDNA remains stable in whole blood for 7 days at 2–30°C or 1 day at 37°C. Change in plasma ccfDNA yield after whole blood sample storage in comparison to plasma separated within 2 hours of blood collection (Day 0). Blood was drawn from a donor pool of approximately 200 consented, apparently healthy adult subjects and stored at various temperatures for the indicated number of days followed by tube centrifugation and ccfDNA purification from plasma using the QIAsymphony PAXgene Blood ccfDNA Kit on the QIAGEN QIAsymphony instrument. The relative ccfDNA yield was calculated as the ratio of the 18S rDNA CT value after sample storage compared to the CT value at Day 0. Medians and the 25th and 75th percentiles are denoted with box plots. Zoom image

Figure 1. Minimal change in ccfDNA levels relative to time 0, after storage at various times and temperatures.

After blood is collected into the tube, the ccfDNA remains stable in whole blood ...
Whole blood from 20 subjects was collected into PAXgene Blood ccfDNA Tubes (CE-IVD), EDTA tubes and blood collection tubes designed for ccfDNA stabilization from 2 other suppliers. Plasma was separated directly after blood draw, after 3 days and after 7 days storage at room temperature (15–25°C). Hemolysis was assessed by measuring plasma free hemoglobin (pfHb) using the Catachem Plasma Free Hemoglobin (PFH) Kit on the Beckman Coulter DxC analyzer. Increase in sample hemolysis during sample storage at room temperature was minimized in PAXgene Blood ccfDNA Tubes (CE-IVD) compared to the other blood collection tubes. This indicates red blood cell lysis and decreased sample integrity in the alternative blood collection tubes. Zoom image

Figure 2. PAXgene Blood ccfDNA stabilization minimizes hemolysis compared to alternative solutions.

Whole blood from 20 subjects was collected into PAXgene Blood ccfDNA Tubes ...
Whole blood was stored in EDTA tubes or PAXgene Blood ccfDNA Tubes (CE-IVD). ccfDNA was extracted from the plasma immediately following blood collection (t0) or after 6 days storage (t6) at room temperature. Eluate (1 µl) was analyzed using the Agilent High Sensitivity DNA Kit. Plasma from EDTA tubes showed an increase in apoptotic gDNA fragments, whereas plasma from PAXgene Blood ccfDNA Tubes (CE-IVD) showed a ccfDNA profile comparable to day 0. Zoom image

Figure 3. PAXgene Blood ccfDNA stabilization reagent helps prevent release of gDNA into plasma.

Whole blood was stored in EDTA tubes or PAXgene Blood ccfDNA Tubes (CE-IVD). ...
Blood was drawn from a donor pool of approximately 200 consented, apparently healthy adult subjects into PAXgene Blood ccfDNA Tubes (CE-IVD). Tubes were centrifuged within 2 hours of blood collection, and an aliquot was extracted from 400 µl of nucleated cellular fraction for processing. The remaining sample in each tube were stored at 2–8°C, 25°C, 30°C, or 37°C for the indicated number of days. DNA was purified from 180 specimens using the QIAsymphony DSP DNA Mini Kit (elution volume: 200 μl) on the QIAGEN QIAsymphony instrument. Medians and the 25th and 75th percentiles are denoted with box plots. Zoom image

Figure 4. PAXgene Blood ccfDNA Tubes (CE-IVD) stabilize genomic DNA in buffy coat or nucleated cellular fractions.

Blood was drawn from a donor pool of approximately 200 consented, apparently ...

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