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) |
|---|---|
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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.
