PAXgene Blood DNA Tube (IVD)

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

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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.

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Get in touch with our specialists if you need a quote or if you would like to discuss your project.

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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 ). 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 ).

See figures

DNA quality and yield from automated extraction on the QIAsymphony.

DNA quality and yield from automated extraction on the QIAcube.

Applications

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

Supporting data and figures

DNA quality and yield from automated extraction on the QIAsymphony.

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/ml 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).

Resources

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

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

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

FAQ

You can find additional information relating to the PreAnalytiX PAXgene products on the PreAnalytiX website .

FAQ ID - 3515

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

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

See subsequent FAQs for information about storage interval and temperature. Each laboratory should validate shipping procedures.

FAQ ID - 3375

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

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

The typical A260/A280 ratio is from 1.7 to 1.9.

FAQ ID - 3383

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

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

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

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

The inside of PAXgene Blood DNA Tubes (IVD) is sterilized during production.

FAQ ID - 3373

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