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PAXgene Urine Liquid Biopsy Set (20) icon_0368_ls_gen_eco_friendly-s
Cat. No. / ID. / ID. 769143
20 tubes: PAXgene Urine Liquid Biopsy Tube (RUO, sterile, 10 mL draw volume, 1.5 mL additive) & 20 cups: PAXgene Urine Collection Cup (RUO, sterile, up to 120 mL urine volume)
The PAXgene Urine Liquid Biopsy Set is for Research Use Only. Not for use in diagnostic procedures.
The PAXgene Urine Liquid Biopsy Tube is for Research Use Only. Not for use in diagnostic procedures.
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).
Supporting data and figures
cfDNA stabilization by minimization of degradation during whole urine storage
Figure depicts the yield of spiked male urine cfDNA in female urine stabilized with the PAXgene Urine Liquid Biopsy Tube after urine storage (Tx; where x equals 3, 7, or 10 days storage) relative to stabilized urine processed within 4 hours of urine collection (T0, set to 1). cfDNA was isolated with the QIAsymphony DSP Circulating DNA Kit and analyzed with the Investigator Quantiplex Pro RGQ assay. Data include 4 urine pools with 3 qPCR replicates. Mean and SD are denoted.
Specifications
| Features | Specifications |
|---|---|
| Format | 20 tubes: PAXgene Urine Liquid Biopsy Tube (RUO, sterile, 10 mL draw volume, 1.5 mL additive); 20 cups: PAXgene Urine Collection Cup (RUO, sterile, up to 120 mL urine volume) |
| Input volume | Up to 120 mL per PAXgene Urine Collection Cup; 10 mL per PAXgene Urine Liquid Biopsy Tube |
| Additive/concentration | 1.5 mL |
| Closure type/color | Yellow BD Hemogard shield with red stopper |
| Stabilization | Length of cfDNA stabilization in urine: up to 10 days at 15-25° C (including room temperature), up to 7 days at 30°C, up to 3 days at 37°C, up to 10 days at 2-8° C; Length of cfDNA stabilization in urine supernatant in a secondary container post-centrifugation: up to 6 months at −20°C or −80°C (long-term study ongoing), up to 3 freeze-thaw cycles at −20°C or −80°C (tested during storage of at least 7 days); Length of cfDNA eluate (Isolated with the QIAamp Circulating Nucleic Acid Kit and the QIAsymphony Circulating DNA Kit, The QIAGEN QIAsymphony Circulating DNA Kit is not available in all countries. For further details please contact QIAGEN Technical Service) stability: up to 1 month at 2−8°C , up to 3 months at −20°C or −80°C (long-term study ongoing), for up to 3 freeze-thaw cycles at −20°C or −80°C (tested during storage for 1 month) |
| Processing | Manual isolation with the QIAGEN QIAamp Circulating Nucleic Acid Kit: 10 mL sample input volume (supplementary protocol, see Resources section below); Note: Lower sample input volumes are also possible, see handbook of QIAamp Circulating Nucleic Acid Kit |
| For automated processing | Automated eisolation with the QIAGEN QIAsymphony Circulating DNA Kit (The QIAGEN QIAsymphony Circulating DNA Kit is not available in all countries. For further details please contact QIAGEN Technical Service) using the QIAGEN QIAsymphony SP Instrument :10 mL sample input volume (customized protocol), please contact QIAGEN Technical Service; Note: Lower sample input volumes are also possible, please contact QIAGEN Technical Service |
Resources
Certificates of Analysis (1)