PAXgene Blood DNA Tube (IVD)

For collection of whole blood for in vitro diagnostic (IVD) DNA testing

S_3923_PAX_BloodDNATubeIVD
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PAXgene Blood DNA Tube (IVD) (10 x 100)

Cat. No. / ID:  761165

1000 PAXgene Blood DNA Tubes (IVD) in 10 boxes (100 tubes/box). This product is sold by BD. Clicking inquire will take you to BD Customer Care.
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The PAXgene Blood DNA Tube (IVD) is intended for in vitro diagnostic use.
Want to try this solution for the first time?
Get in touch with our specialists if you need a quote or if you would like to discuss your project.

Features

  • For In Vitro Diagnostic Use
  • Compatible with automated purification technologies
  • Validated for various collection and storage conditions
  • Unique blue cap and label identify tube for DNA testing
  • 2D barcode with tube ID, lot number and expiration date

Product Details

The PAXgene Blood DNA Tube (IVD) is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate the use of a product for their specific molecular diagnostic assay. The intended use and claims have been validated with the QIAamp DSP DNA Blood Mini Kit (IVD) and the QIAsymphony DSP DNA Kit (IVD).

Performance

The performance of the PAXgene Blood DNA Tube (IVD) has been validated under several processing temperatures and time intervals relevant to variation in blood collection techniques, transport methods and storage conditions. Validation information, along with data from exposure to high temperatures, long-term storage at –20°C and freeze-thaw tests are available under the Resources tab.
The table below summarizes DNA yields from whole blood collected in PAXgene Blood DNA Tubes (IVD) and purified using 2 different technologies. The yield of genomic DNA purified from blood samples collected in PAXgene Blood DNA Tubes (IVD) varies depending on the volume of blood processed, the white blood cell count of the specimen and the selected DNA isolation method.

 

Table 1. DNA yield from PAXgene Blood DNA Tubes (IVD) using 2 isolation technologies
Extraction method Number of samples Input volume
(µl)
Output volume
(µl)
Lower 95% tolerance limit
(µg DNA/ml whole blood)
Median
(µg DNA/ml whole blood)
Mean
(µg DNA/ml whole blood)
Magnetic beads (QIAsymphony) 581 200 200 18.2 28.9 30.2
Silica membrane (QIAcube) 540 200 100 9.3 22.5 24.4

Principle

The PAXgene Blood DNA Tube (IVD) is a plastic, evacuated blood collection tube designed for in vitro diagnostic DNA testing. The tube includes features that minimize the risk of specimen misidentification: a distinctive blue rubber stopper in the Hemogard closure identifies the tube for DNA testing, and a 2D barcode on the label contains a unique tube identifier number, the tube lot number and the expiration date.

Procedure

Blood is collected into PAXgene Blood DNA Tubes (IVD) using standard phlebotomy techniques. The tube is designed to draw 2.5 ml of whole blood and this volume is easily identified by the fill indicator on the tube label. Venous whole blood can be stored in PAXgene Blood DNA Tubes (IVD) for up to 14 days at room temperature (18–25°C), 28 days at 2–8°C and for up to 52 weeks at –20°C.
For streamlined and standardized processing, PAXgene Blood DNA Tubes (IVD) are designed to integrate into automated workflows. For example, PAXgene Blood DNA Tubes (IVD) are compatible with DNA purification via magnetic beads in combination with QIAsymphony DSP DNA Kits (see figure  DNA quality and yield from automated extraction on QIAsymphony). PAXgene Blood DNA Tubes (IVD) are also compatible with DNA purification via silica membrane in combination with QIAamp DSP DNA Blood Mini Kits (see figure  DNA quality and yield from automated extraction on QIAcube).
See figures

Applications

PAXgene Blood DNA Tubes (IVD) can be used for molecular diagnostic methods requiring DNA.

Supporting data and figures

Resources

Kit Handbooks (1)
For collection of whole blood to be used for in vitro diagnostic (IVD) DNA testing
Safety Data Sheets (1)
White Papers (1)
Performance of the PAXgene Blood DNA Tube (IVD) for collection, transportation, and storage of whole blood and the purification of DNA using the QIAsymphony instrument
Brochures & Guides (1)
For collection of whole blood to be used for in vitro diagnostic (IVD) DNA testing
Certificates of Analysis (1)

FAQ

How should blood samples drawn into PAXgene Blood DNA Tubes (IVD) be stored?

Blood samples in PAXgene Blood DNA Tubes (IVD) can be stored at room temperature (18–25°C) for up to 14 days or at 2–8°C for up to 28 days. For long-term storage, samples should be frozen at –20°C.

FAQ ID - 3585
Where can I find additional information for PreAnalytiX PAXgene products?
You can find additional information relating to the PreAnalytiX PAXgene products on the PreAnalytiX website .
FAQ ID - 3515
Do I have to use a blood collection set with PAXgene Blood DNA Tubes (IVD)?

No, a blood collection set is not required to use PAXgene Blood DNA Tubes (IVD). Further information on phlebotomy technique with PAXgene Blood DNA Tubes (IVD) can be found in the product handbook.

FAQ ID - 3370
What is the shelf life of PAXgene Blood DNA Tubes (IVD) prior to blood collection?
The shelf life of unused PAXgene Blood DNA Tubes (IVD) is 1 year. The expiration date is printed on the tube label and on the shelf carton. Store PAXgene Blood DNA Tubes (IVD) at room temperature (18–25°C).
FAQ ID - 3374
Are there any special considerations for the collection of blood using PAXgene Blood DNA Tubes (IVD) (e.g., use of a blood collection set or discard tube, positioning of the tube, issues with short draws, etc.)?
Blood collection using PAXgene Blood DNA Tubes (IVD) is performed using standard phlebotomy protocol. Blood is collected into the evacuated tube using a needle or blood collection set with a standard needle holder that can accommodate a 13 mm diameter tube. Further information on phlebotomy technique with PAXgene Blood DNA Tubes (IVD) can be found in the product handbook.
FAQ ID - 3371
How should blood samples drawn into PAXgene Blood DNA Tubes (IVD) be transported?
See subsequent FAQs for information about storage interval and temperature. Each laboratory should validate shipping procedures.
FAQ ID - 3375
How long can samples in PAXgene Blood DNA Tubes (IVD) be stored at room temperature?

Samples in PAXgene Blood DNA Tubes (IVD) can be stored at room temperature (18–25°C) for up to 14 days after blood collection.

FAQ ID - 3378

How long can samples in PAXgene Blood DNA Tubes (IVD) be stored at 2–8°C?

Samples in PAXgene Blood DNA Tubes (IVD) can be stored at 2-8°C for up to 28 days after blood collection.

FAQ ID - 3379
What is the expected purity of DNA extracted from blood samples collected in PAXgene Blood DNA Tubes (IVD)?
The typical A260/A280 ratio is from 1.7 to 1.9.
FAQ ID - 3383
How should frozen PAXgene Blood DNA Tubes (IVD) be thawed?
Thaw PAXgene Blood DNA Tubes (IVD) in a wire rack at room temperature (18–25°C) for approximately 2 hours. Carefully invert the thawed PAXgene Blood DNA Tubes (IVD) 10 times.
FAQ ID - 3586
Can PAXgene Blood DNA Tubes (IVD) be stored at higher than room temperature (18–25°C)?

Yes, samples in PAXgene Blood DNA Tubes (IVD) can be stored at 35°C for up to 3 days after blood collection. However, it is not recommended to store blood samples at temperatures higher than 35°C and storage at high temperatures should not exceed 3 days.

FAQ ID - 3380
What is the additive in PAXgene Blood DNA Tubes (IVD)?
PAXgene Blood DNA Tubes (IVD) contain a proprietary EDTA formulation. Contents of the tube may cause irritation to eyes, respiratory system, and skin. For more information, please refer to the product handbook, download the SDS or contact BD Technical Service.
FAQ ID - 3372
Which downstream applications have been tested with DNA purified from samples collected in PAXgene Blood DNA Tubes (IVD)?
To date, DNA purified from blood samples in PAXgene Blood DNA Tubes (IVD) has been successfully tested for use in PCR, including multiplex PCR.
FAQ ID - 3384
What is the expected DNA yield from 2.5 ml of blood collected in the PAXgene Blood DNA Tube (IVD)?

Yield of genomic DNA varies depending on the white blood cell count of the patient blood sample, the extraction method and the elution volume. DNA yields from magnetic bead-based extraction on the QIAsymphony ranges between 12.2-54.0 µg/ml whole blood and from silica membrane-based extraction on the QIAcube between 3.7–105.6 µg/ml whole blood.

FAQ ID - 3382
Are PAXgene Blood DNA Tubes (IVD) sterile?
The inside of PAXgene Blood DNA Tubes (IVD) is sterilized during production.
FAQ ID - 3373
Can blood samples be frozen in PAXgene Blood DNA Tubes (IVD)?

Yes, PAXgene Blood DNA Tubes (IVD) can be stored at –20°C for 52 weeks (long-term storage studies are ongoing). 

For freezing, place PAXgene Blood DNA Tubes (IVD) upright in a wire rack or horizontally in a plastic bag. Do not freeze tubes upright in a styrofoam tray as this may cause the tubes to crack. DNA stored in PAXgene Blood DNA Tubes (IVD) is suitable for DNA testing for up to 3 freeze-thaw cycles.

FAQ ID - 3377