Qiagen, 769114, PAXgene Urine Liquid Biopsy Tube (50)

50 sterile tubes/case1 Tube: 10.0 mL draw volume, 1.5 mL additive, Dimensions: 16 × 100 mm tube Safety-engineered BD Hemogard™ closure, Red stopper with Yellow shield

Features

- Stabilization of cfDNA for various days at various temperatures minimizes post-collection cfDNA profile changes during transport and storage
- User-friendly urine collection device that is convenient for individuals and laboratory professionals
- Closed sample transfer into a sterile tube, minimizing microbial contamination and biospecimen exposure
- Verified with QIAGEN manual and automated cfDNA isolation technologies
- High-quality sample† with unmodified cfDNA for various downstream applications († determined by qPCR with Investigator Quantiplex Pro RGQ Kit)

Product Details

The PAXgene Urine Liquid Biopsy Set consists of a urine collection cup (PAXgene Urine Collection Cup) and a nucleic acid stabilizing tube (PAXgene Urine Liquid Biopsy Tube). It is intended for the collection, storage and transport of human urine specimen and stabilization of cell-free DNA (cfDNA) profile. The set is part of a complete preanalytical workflow for molecular testing, including the QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit.

The PAXgene Urine Liquid Biopsy Set is for Research Use Only. Not for use in diagnostic procedures.

The PAXgene Urine Liquid Biopsy Tube is a plastic, closed, evacuated tube intended for direct sampling from the PAXgene Urine Collection Cup, stabilization of cell free DNA (cfDNA) profile, storage and transport of a human urine specimen. The tube is part of a complete preanalytical workflow for molecular testing, including cfDNA isolation using QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit.

The PAXgene Urine Liquid Biopsy Tube is for research use only. Not for use in diagnostic procedures.

Performance

The PAXgene Urine Liquid Biopsy Set is part of a complete preanalytical workflow for molecular testing including sample collection and stabilization as well as cfDNA isolation using the QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit (See figure "The PAXgene Urine Liquid Biopsy Set (RUO) workflow"). The PAXgene Urine Liquid Biopsy Set allows easy-to-use urine collection in a standard cup and closed sample transfer into a sterile tube minimizing microbial contamination and biospecimen exposure. cfDNA is stabilized by minimization of cfDNA degradation, by minimization of gDNA release and by minimization of bacterial growth over urine storage (See figures “cfDNA stabilization by minimization of degradation during whole urine storage”, “cfDNA stabilization by minimization of gDNA release during whole urine storage”, “cfDNA stabilization by minimization of bacterial growth during urine storage”).

The additive in the tube is non-crosslinking and does not modify biomolecules like cfDNA.

Samples can be transported in a range of environments (e.g., room temperature, refrigerated or frozen (See figures “cfDNA stabilization by minimization of degradation during whole urine storage”, “cfDNA stabilization by minimization of gDNA release during whole urine storage”, “cfDNA stabilization by minimization of bacterial growth during urine storage”). Please see the handbook (see Resources section below) for more details.

Following centrifugation and separation from cellular components, stabilized cfDNA can be isolated from the urine supernatant by manual or automated procedures using the QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit, respectively. The resulting unmodified cfDNA is of high quality (as shown using qPCR) and suitable for various downstream applications. Please see the handbook (see Resources section below) for more details.

Principle

Cell-free DNA (cfDNA) in urine is an avenue for liquid biopsy research. In addition to being a standalone source of biomarkers, urine cfDNA has been shown to provide complementary information to blood cfDNA.

However, analysis of urine cfDNA is highly workflow dependent as shown in a research study within the EU consortium EASI Genomics (This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 824110). The cfDNA profile in unstabilized urine was impacted rapidly by cfDNA degradation post collection (See figure “Change in cfDNA yield during storage of unstabilized and stabilized urine”). Furthermore, the cfDNA profile can be diluted by post collection release of genomic DNA from body cells and bacteria.

Reliable urine cfDNA analysis can only be achieved with urine stabilization (See figure “Change in cfDNA yield during storage of unstabilized and stabilized urine”) integrated into a complete preanalytical workflow.

The PAXgene Urine Liquid Biopsy Set, which is comprised of the PAXgene Urine Collection Cup and the PAXgene Urine Liquid Biopsy Tube, enables standardized collection and stabilization of urine specimens. Urine cfDNA is stabilized in the PAXgene Urine Liquid Biopsy Tube for various durations at various temperatures and facilitates transport and storage of urine (See figure “The PAXgene Urine Liquid Biopsy Set (RUO) workflow”).

The PAXgene Urine Collection Cup is used to collect urine. The evacuated PAXgene Urine Liquid Biopsy Tube is used to sample urine directly from the cup into the tube without the need to open the tube or the cup. Using the PAXgene Urine Liquid Biopsy Set for urine stabilization according to the handbook ensures a consistent ratio of urine to additive (See figure “Handling of the PAXgene Liquid Biopsy Set after urine collection”).

The stabilized urine is compatible with QIAGEN manual and automated cfDNA isolation technologies. Please see the handbook (see Resources section below) for more details.

The isolated cfDNA eluates are compatible with various downstream technologies (See figure “TThe PAXgene Urine Liquid Biopsy Set (RUO) workflow”).

Procedure

The PAXgene Urine Collection Cup is a plastic BD Vacutainer® urine collection cup for collection of up to 120 mL of urine. The evacuated PAXgene Urine Liquid Biopsy Tube contains 1.5 mL of additive and is used to sample urine directly from the PAXgene Urine Collection Cup via a needle integrated in the blue cap of the cup. The stopper of the PAXgene Urine Liquid Biopsy Tube is pierced by the needle and the vacuum in the tube enables a flow of 10 mL of urine through a straw in the PAXgene Urine Collection Cup cap.

Directly after urine collection, the unstabilized urine is transferred into the PAXgene Urine Liquid Biopsy Tube for stabilization of urine. This technology allows for convenient and safe collection and stabilization of urine with consistent ratio of urine to additive.

To stabilize more than 10 mL of urine, multiple PAXgene Urine Liquid Biopsy Tubes can be filled from the same cup depending on the total volume of urine collected into the cup.

Applications

Compatible with various assay technologies, e.g., dPCR and qPCR. Please see the handbook (see Resources section below) for more details.

Further downstream applications with urine

See externally conducted research studies from Christian Doppler Laboratory for Liquid Biopsies for Early Detection of Cancer using the PAXgene Urine Liquid Biopsy technology with next-generation sequencing (NGS).