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PAXgene Blood DNA Tube (IVD)

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

  • 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

Feature 

Specification

Tube size

13 x 75 mm

Blood draw volume

2.5 ml

Additive  

Spray-dried proprietary additive formulation

Performance testing 

  • 14 days at room temperature (18–25°C)
  • 28 days at 2–8°C
  • 3 days at 35°C
  • 52 weeks at –20°C*
  • 3 freeze-thaw cycles

Closure type/color

BD Hemogard/Blue

Quantity 

10 boxes per case; 100 tubes per box

*Long-term study of blood storage in PAXgene Blood DNA Tubes at –20°C is ongoing.


Intended Use

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 use of 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).

Order information

Product

Catalog Nr.

Price

PAXgene Blood DNA Tubes (100) IVD

100 blood collection tubes (2.5 ml).

761165
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Details

The PAXgene Blood DNA Tube (IVD) can be coupled to generic DNA preparation solutions to accommodate in vitro diagnostic workflows. The PAXgene Blood DNA Tube (IVD) has been validated with the QIAamp DSP DNA Blood Mini Kit (IVD) for automation on the QIAcube and the QIAsymphony DSP DNA Kit (IVD) for automation on the QIAsymphony. The table below offers a quick comparison to the PAXgene Blood DNA System, which is for research use only.

Table 1. Comparison PAXgene Blood DNA System (RUO) and PAXgene Blood DNA Tube (IVD)

PAXgene Blood DNA System

PAXgene Blood DNA Tube (IVD)

  • Research use only
  • Large blood draw volume (8.5 ml)
  • Integrated system with collection tube and DNA purification kit
  • Manual DNA purification
  • In vitro diagnostic
  • Small blood draw volume (2.5 ml)
  • Can be used with silica membrane and magnetic bead DNA purification methods
  • Validated with QIAGEN DNA purification kits for automated workflows
 
Performance

The PAXgene Blood DNA Tube (IVD) is a blood collection tube that is robust to handling variability and easily integrated into standard automated workflows. 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 Resources.

The table below summarizes DNA yields from whole blood collected in PAXgene Blood DNA Tubes (IVD) and purified using two different technologies. The yield of genomic DNA purified from blood samples collected in PAXgene Blood DNA Tubes varies depending on the volume of blood processed, the white blood cell count of the specimen, and the selected DNA isolation method.

Table 2. DNA yield using two isolation technologies

Extraction method

Magnetic beads (QIAsymphony)  

Silica membrane (QIAcube)

Number of samples

581

540

Input volume (µl)

200

200

Output volume (µl)

200

100

Lower 95% tolerance limit (µg DNA/ml whole blood)    

18.2

9.3

Median (µg DNA/ml whole blood)    

28.9

22.5

Mean (µg DNA/ml whole blood

30.2

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 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 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 (Figure 1). PAXgene Blood DNA Tubes (IVD) are also compatible with DNA purification via silica membrane in combination with QIAamp DSP DNA Blood Mini Kits (Figure 2).

Applications

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


The PAXgene Blood DNA Tube (IVD) is for in vitro diagnostic use.
 

Samples collected in PAXgene Blood DNA Tubes (IVD) were processed at one site (internal) on the QIAsymphony, which performs automated DNA purification based on magnetic bead extraction. Median DNA yield was 28.9 µg DNA/ml blood, with 95% of samples ≥18.2 µg DNA/m blood. DNA purity is equally high, with an A260/A280 ratio of 1.7–1.9. Extraction was performed using QIAsymphony DSP DNA Kits (200 µl blood sample input, 200 µl DNA eluate output).Zoom image

Figure 1. DNA quality and yield from automated extraction on the QIAsymphony.

Samples collected in PAXgene Blood DNA Tubes (IVD) were processed at one site ...
Samples collected in PAXgene Blood DNA Tubes (IVD) were processed at 5 sites (4 external, 1 internal) on the QIAcube, which performs automated DNA extraction based on silica membrane technology. Median DNA yield was 22.5 µg DNA/ml blood, with 95% of samples ≥9.3 µg DNA/ml blood. DNA purity is high, with an A260/A280 ratio of 1.7–2.1. Extraction was performed using QIAamp DSP DNA Blood Mini Kits (200 µl blood sample input, 100 µl DNA eluate output).Zoom image

Figure 2. DNA quality and yield from automated extraction on the QIAcube.

Samples collected in PAXgene Blood DNA Tubes (IVD) were processed at 5 sites (4 ...

Resources

PAXgene Blood DNA Tube (IVD)

Sample Collection and Phlebotomy

1. 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 Handbook.

2. 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 Handbook.

3. 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 Handbook, download the SDS, or contact BD Technical Service.

4. Are PAXgene Blood DNA Tubes (IVD) sterile?
The inside of PAXgene Blood DNA Tubes (IVD) is sterilized during production.

5. 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).

Sample Transport

1. 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.

Sample Storage and Archiving

1. 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.

2. 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 PAXgene Blood DNA Tubes (IVD) is suitable for DNA testing for up to 3 freeze-thaw cycles.

3. 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.

4. 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.

5. 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.

DNA Isolation and Processing

1. 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.

2. What is the expected DNA yield from 2.5 ml of blood?
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.

3. 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.

Downstream Applications

1. 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.

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