Description
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).
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
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.
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).
