PAXgene Urine Liquid Biopsy Set

The first verified, complete standardized preanalytical workflow that stabilizes cell-free DNA (cfDNA) in urine for subsequent analysis
 

  • 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

Feature

Specification

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)
Urine collection volumeUp to 120 mL per PAXgene Urine Collection Cup
Urine stabilization volume10 mL per PAXgene Urine Liquid Biopsy Tube

Tube additive volume

1.5 mL

Tube closure type/color

Yellow BD Hemogard shield with red stopper

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* 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)
cfDNA isolation from stabilized urine

Manual 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

 

Automated with the QIAGEN QIAsymphony Circulating DNA Kit** using the QIAGEN QIAsymphony SP Instrument 

*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 

For details regarding verification study results refer to the Performance Characteristics section of the product handbook (see Resources section below).

Intended Use

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.

For Research Use Only. Not for use in diagnostic procedures. The performance characteristics of this product have not been fully established.

Order information

Product

Catalog No.

Price

PAXgene Urine Liquid Biopsy Set (20)

20 tubes: PAXgene Urine Liquid Biopsy Tube (RUO, sterile, 10.0 mL draw volume, 1.5 mL additive) 20 cups: PAXgene Urine Collection Cup (RUO, sterile, up to 120 mL urine volume)

769143
230 EUR
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Details

Principle

Introduction

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††. The cfDNA profile in unstabilized urine was impacted rapidly by cfDNA degradation post collection (Figure 1A).  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 (Figure 1B) integrated into a complete preanalytical workflow.

 

The PAXgene Urine Liquid Biopsy Set

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 (Figure 2).

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 (Figure 3). 

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 (Figure 2). 

 

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 (Figure 2). 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 (Figure 4, 5, 6).
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 (Figure 4, 5, 6). 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.

 

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 Liquid Biopsy technology with next-generation sequencing (NGS).

 

Resources

PAXgene Urine Liquid Biopsy Set

2.3 MB

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Urine Collection Procedure with PAXgene Urine Collection Cup Protocol Sheet

952.1 KB

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Protocol: Purification of cell-free DNA from 10 mL Urine from the PAXgene Urine Liquid Biopsy Tube using the QIAamp Circulating Nucleic Acid Kit

218.2 KB

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Turn urine to liquid gold - with the PAXgene Urine Liquid Biopsy Set

3.5 MB

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PAXgene Urine Liquid Biopsy Set - SDS

Learn more

cfDNA analysis from urine samples using the PAXgene Urine Liquid Biopsy Set for stabilization and standardization of preanalytical workflows (Voss, EACR LB 2024)

5.4 MB

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Hybrid capture based sequencing library approach for cell free DNA from urine of colorectal cancer patients (Eberhard et al., AACR 2024)

2.8 MB

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Preanalytical workflow enabling cfDNA analysis from urine samples (Mancarella, AACR 2024)

6.0 MB

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Video: Urine cell-free DNA is a challenging sample type for liquid biopsy research

50.0 MB

Download
Sample Collection and Stabilization of Urine and cfDNA
1. Do I need to use PAXgene Urine Liquid Biopsy Tubes only with the PAXgene Urine Collection Cup from the PAXgene Urine Liquid Biopsy Set?
Yes. Further information can be found in the PAXgene Urine Liquid Biopsy Set Handbook accessible under the Resources tab on www.preanalytix.com.

2. Can I use the PAXgene Urine Liquid Biopsy Tube with regular urine collection cup?
The PAXgene Urine Liquid Biopsy Tube is not designed for use with open urine collection cups requiring manual sample transfer into the tube. It is not recommended to manually fill the PAXgene Urine Liquid Biopsy Tube from a syringe or other methods due to increased risk of biohazard exposure, needle stick injury and incorrect urine to additive ratio that may affect product performance. Additionally, removal of the stopper may compromise the sterility of the tube and increase risk of sample contamination.

3. What is the collection volume of the PAXgene Urine Collection Cup?
What is the collection volume of the PAXgene Urine Collection Cup? An individual can void up to 120 mL of urine in the cup. A minimum of 15 mL is recommended to be present in the cup to fill one tube.

4. What is the draw volume of the PAXgene Urine Liquid Biopsy Tube?
What is the draw volume of the PAXgene Urine Liquid Biopsy Tube? The urine draw volume is 10 mL and the additive volume is 1.5 mL. Thus, a filled tube holds a volume of 11.5 mL. Multiple tubes can be drawn from one urine collection cup. Further information can be found in the PAXgene Urine Liquid Biopsy Set Handbook accessible under the Resources tab on www.preanalytix.com.

5. How can I stabilize more than 10 mL from the same urine specimen?
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. If more than one PAXgene Urine Liquid Biopsy Tube will be filled from the same urine sample, the blue cap of the PAXgene Urine Collection Cup should be unscrewed, slightly lifted and screwed back on without lifting it off completely. Then repeat the steps for each tube as mentioned in the Handbook.

6. I want to stabilize more than 10 mL from the same urine specimen. Can I buy more tubes?
Yes. Further information on ordering additional tubes can be found under Other Products Used in Conjunction on www.preanalytix.com.

7. I followed the instructions on stabilizing, but the tube still filled insufficiently.
To ensure 10 mL of urine is transferred into the PAXgene Urine Liquid Biopsy Tube from the PAXgene Urine Collection Cup, insert the PAXgene Urine Liquid Biopsy Tube with the yellow tube closure facing down into the cavity of the blue cup cap. Push quickly and firmly to puncture the stopper and hold the tube down to begin filling the tube. Hold the PAXgene Urine Liquid Biopsy Tube in place until the tube stops filling. Pushing the tube into the cavity of the blue cup cap slowly may result in tube underfilling. Further, the quantity of urine drawn should be approximately 10 mL for the PAXgene Urine Liquid Biopsy Tube, but this volume may vary depending on various factors such as altitude, ambient temperature, barometric pressure, tube age, and filling technique.

8. Can I stabilize my samples 1 hour after collection into the PAXgene Urine Collection Cup?
The time between urine donation and stabilization of the specimen in the PAXgene Urine Liquid Biopsy Tube is crucial for the successful stabilization of cfDNA. Degradation of cfDNA progresses more rapidly in urine compared to other body fluids like blood if it is not stabilized. Therefore, the time between collection and stabilization should be reduced as much as possible. Ensure the time of specimen collection is recorded and urine is stabilized by transferring into PAXgene Urine Liquid Biopsy Tube within 15 minutes of collection.

9. How does the additive in the PAXgene Urine Liquid Biopsy Tube stabilize cfDNA?
The PAXgene Urine Liquid Biopsy Tube additive is non-crosslinking. Stabilization of cfDNA levels is accomplished by minimizing degradation of cfDNA, minimizing release of gDNA, and minimizing microbial growth during sample storage.

10. What is the additive in the PAXgene Urine Liquid Biopsy Tube?
The PAXgene Urine Liquid Biopsy Tube contains a proprietary formulation that stabilizes cfDNA levels by minimizing degradation of cfDNA, minimizing release of gDNA, and minimizing microbial growth during sample storage. For additional information, visit www.preanalytix.com or review the Safety Data Sheet under the Resources tab.

11. The PAXgene Urine Liquid Biopsy additive has a slightly yellow appearance; does this affect the performance of the additive?
No, a slightly yellow appearance does not affect the performance of the additive as long as the tubes are used before their expiration date.

Storage and Processing
12. What is the shelf life of an unused PAXgene Urine Liquid Biopsy Set?
The shelf life of the set is 12 months from the date of manufacture. The expiration date is printed on the set label.

13. How should an unused PAXgene Urine Liquid Biopsy Set be stored?
Store the unused PAXgene Urine Liquid Biopsy Set at 4–25°C.

14. Is the PAXgene Urine Liquid Biopsy Set sterile?
Yes, the interior of the PAXgene Urine Liquid Biopsy Set components (PAXgene Urine Liquid Biopsy Tube and PAXgene Urine Collection Cup) are sterile. The sterilization method used is gamma irradiation.

15. How long can urine stabilized in the PAXgene Urine Liquid Biopsy Tube be stored at room temperature?
Urine drawn into PAXgene Urine Liquid Biopsy Tube can be stored at 15–25°C for up to 10 days. For further information, please review the Performance Characteristics section of the product handbook.

16. Can urine in the PAXgene Urine Liquid Biopsy Tube be stored at temperatures above 25°C?
Yes. Urine drawn into PAXgene Urine Liquid Biopsy Tubes can be stored for up to 7 days at 30°C or for up to 3 days at 37°C. For further information, please review the Performance Characteristics section of the product handbook.

17. Can urine in the PAXgene Urine Liquid Biopsy Tube be stored at temperatures below 15°C?
Yes. Urine drawn into PAXgene Urine Liquid Biopsy Tube can be stored for up to 10 days at 2–8°C. For further information, please review the Performance Characteristics section of the product handbook.

18. Can urine be frozen in the PAXgene Urine Liquid Biopsy Tube?
No. Freezing of whole urine is not recommended. Cell-free urine supernatant after centrifugation can be transferred into a suitable tube and frozen according to Handbook.

cfDNA Isolation and Processing
19. What is the expected cfDNA yield from 10 mL urine?
The concentration of cfDNA in urine may be low and varies considerably by many factors including among different individuals, sex and health status of the donating individual, time of collection and hydration status.

20. What is the expected cfDNA yield from 2–4 mL urine?
The concentration of cfDNA in urine may be low and varies considerably by many factors including among different individuals, sex and health status of the donating individual, time of collection and hydration status.

21. Which cfDNA isolation kits are compatible with the PAXgene Urine Liquid Biopsy Set?
Isolation of cfDNA from the PAXgene Urine Liquid Biopsy Tube stabilized urine can be performed manually or automated using the QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit (QIAGEN QIAsymphony Circulating DNA Kit is not available in all countries. For further details please contact www.support.qiagen.com)

22. What urine volumes can be processed on the QIAGEN QIAsymphony SP instrument using the QIAGEN QIAsymphony Circulating DNA Kit?
For 10 mL sample input volume, please contact QIAGEN Technical Service. Other sample input volumes are also possible, please visit support.qiagen.com.

23. What urine volumes can be processed using the QIAGEN QIAamp Circulating Nucleic Acid Kit?
For 10 mL sample input volume, see Supplementary Protocols under the Resources tab on www.preanalytix.com. Other sample input volumes are also possible, please visit support.qiagen.com.

24. How should cfDNA isolated from the PAXgene Urine Liquid Biopsy Tube with QIAGEN QIAamp Circulating Nucleic Acid Kit or the QIAGEN QIAsymphony Circulating DNA Kit be stored?
It is recommended to store cfDNA eluates at 2–8°C for up to 1 month or at –20 °C or –80 °C for up to 3 months (long-term study ongoing), or for up to 3 freeze-thaw cycles at –20 °C or –80 °C (tested during storage for 1 month). For further information, please refer to the PAXgene Urine Liquid Biopsy Set Handbook available under resources on www.preanalytix.com

Downstream Applications
25. Which downstream applications have been tested with cfDNA isolated from urine collected and stabilized with the PAXgene Urine Liquid Biopsy Set?
cfDNA isolated from urine collected and stabilized in the PAXgene Urine Liquid Biopsy Set can be used in a range of downstream molecular applications and testing methods requiring cfDNA, such as: PCR, including digital and quantitative real-time PCR.

Other Products Used in Conjunction

PAXgene Urine Liquid Biopsy Tube (RUO)
QIAamp Circulating Nucleic Acid Kit
QIAsymphony SP/AS instruments
Rotor-Gene Q
QIAcuity

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