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PAXgene Blood ccfDNA Tube (CE-IVD)

For collection of whole blood samples and stabilization of ccfDNA

  • 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 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. Do not store blood-filled tubes below 2°C.
  • 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

  • 2 - 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.

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
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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 is non-crosslinking, free of formaldehyde-releasing substances, 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 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. 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 automatedQIAsymphony 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, 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 subsequent 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 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

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. After collection, the whole blood sample 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 methodsbased on magnetic bead or silica membrane technologies. 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 based on magnetic bead or silica membrane technologies.

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, such as:

  • 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 PAXgene Blood ccfDNA Tubes (CE-IVD), ccfDNA remains stable in whole blood 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. Do not store blood-filled tubes below 2°C  Depicted is the 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 QIAGEN QIAamp Circulating Nucleic Acid Kit. 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 indicated (blue lines).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 PAXgene Blood ccfDNA Tubes (CE-IVD), ccfDNA remains ...
For each storage temperature whole blood was collected from 20 subjects into PAXgene Blood ccfDNA Tubes (CE-IVD), EDTA tubes and blood collection tubes designed for ccfDNA stabilization from 3 other suppliers were stored for a maximum of 10 days. Blood collected was handled and processed per the manufacturer recommended handling conditions for each tube type. At each test interval (day 7 and day 10), 1 mL aliquot of whole blood was sampled from each tube into a secondary container.  Hemolysis Index (mg/dl)) was tested on the Roche Cobas 6000.  Increase in sample hemolysis over time during sample storage at 4C (refrigerated) and 25C (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.

For each storage temperature whole blood was collected from 20 subjects into ...
Whole blood was stored in EDTA tubes or PAXgene Blood ccfDNA Tubes (CE-IVD). ccfDNA was extracted from the plasma within 2 h following blood collection (t0) or after 10 days storage 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 prevents release of gDNA into plasma.

Whole blood was stored in EDTA tubes or PAXgene Blood ccfDNA Tubes (CE-IVD). ...
gDNA Concentration using an Automated, Magnetic Bead-Based DNA Purification System: 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 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: 400 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.

gDNA Concentration using an Automated, Magnetic Bead-Based DNA Purification ...

ccfDNA quality and stabilization chemistry  -

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Resources

PAXgene Blood ccfDNA Tube (CE-IVD) Handbook

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How to Collect Blood Using the PAXgene Blood ccfDNA Tube CE-IVD for Circulating Cell-Free DNA

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PAXgene Blood ccfDNA Tube CE-IVD - For Stabilization of ccfDNA from Whole Blood

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PAXgene Blood ccfDNA System Transport Concept

1.6 MB

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SDS PAXgene Blood ccfDNA Tube (CE-IVD)

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Lampignano R., et al. (2020) Multicenter Evaluation of Circulating Cell-Free DNA Extraction and Downstream Analyses for the Development of Standardized (Pre)analytical Workflows. Clin. Chem. doi: 10.1373/clinchem.2019.306837

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Solakoglu, Ö., et al. (2019) Characterization of circulating DNA in plasma of patients after allogeneic bone grafting. Clin. Oral Investig. [Epub ahead of print] doi: 10.1007/s00784-019-02867-3

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Zhou, R., et al. (2018) Using digital PCR to detect HER2 amplification in breast and gastric cancer patients. Frontiers Lab. Med. 2, 102. doi: 10.1016/j.flm.2018.11.002

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Zhou, R., et al. (2018) A digital PCR assay development to detect EGFR T790M mutation in NSCLC patients. Frontiers Lab. Med. 2, 89. doi: 10.1016/j.flm.2018.08.002

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Nikolaev, S., et al. (2018) Circulating tumoral DNA: Preanalytical validation and quality control in a diagnostic laboratory. Anal. Biochem. 542, 34. doi: 10.1016/j.ab.2017.11.004.

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Groelz, D., et al. (2018) Liquid biopsy preservation solutions for standaridzed pre-analytical workflows – Venous whole blood and plasma. Curr. Pathobiol. Rep. 6, 275. doi: 10.1007/s40139-018-0180-z

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Schmidt, B., et al. (2017) Liquid biopsy – Performance of the PAXgene Blood ccfDNA Tubes for the isolation and characterization of cell-free DNA from tumor patients. Clin. Chim. Acta 469, 94. doi: 10.

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Warton, K., et al. (2017) Evaluation of Streck BCT and PAXgene Stabilised Blood Collection Tubes for Cell-Free Circulating DNA Studies in Plasma. Mol. Diagn. Ther. 21, 563. doi: 10.1007/s40291-017-028

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Alidousty, C., et al. (2017) Comparison of Blood Collection Tubes from Three Different Manufacturers for the Collection of Cell-Free DNA for Liquid Biopsy Mutation Testing. J. Mol. Diagn. 19, 801. doi

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Webinar - Considerations when generating diagnostic samples for ccfDNA analysis (March 2020)

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Performance Comparison of PAXgene and Streck Stabilization Blood Collection Tubes for ccfDNA Testing

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Guidance Documentation for User Evaluation of Blood Collection Tubes for ccfDNA Applications

823.4 KB

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