Image of PAXgene Blood DNA Tube (761165)

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 HemogardTM Safety Closure with transparent shield and blue stopper

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 No.

Price

PAXgene Blood DNA Tubes (10 x 100), IVD

1000 blood collection tubes (2.5 ml) in 10 boxes (100 tubes/box)

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 (RUO)

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 QIAsymphony DSP DNA Kit(IVD) (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.
 

Resources

PAXgene Blood DNA Tube (IVD) Handbook

299.2 KB

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PAXgene Blood DNA Tube and System Brochure

1.4 MB

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(EN) Important Note: PreAnalytiX GmbH street address has changed from “Feldbachstrasse” to “Garstligweg 8”

158.9 KB

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