PAXgene Urine Liquid Biopsy Set (RUO)

Urine collection and cell-free DNA stabilization from urine liquid biopsy samples

Products

PAXgene Urine Liquid Biopsy Set (20)

Cat. No. / 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)

Inquire

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

PAXgene Urine Liquid Biopsy Tube (50)

Cat. No. / ID: 769114

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

Inquire

If more than one PAXgene Urine Liquid Biopsy Tube will be filled from the same urine specimen collected in the PAXgene Urine Collection Cup*, PreAnalytiX recommends to purchase additional PAXgene Urine Liquid Biopsy Tubes.*The PAXgene Urine Collection Cup is part of the PAXgene Urine Liquid Biopsy Set (Cat No. 769143) and not sold separately.

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.

cfDNA stabilization by minimization of gDNA release during whole urine storage

cfDNA stabilization by minimization of bacterial growth during whole urine storage

Change in cfDNA yield during storage of unstabilized and stabilized urine

The PAXgene Urine Liquid Biopsy Set (RUO) workflow

Handling of the PAXgene Liquid Biopsy Set after urine collection

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

Safety Data Sheets for PreAnalytiX products sold by BD are available for download from the BD website. Go to the site and search with the catalog number to find your SDS.

FAQ

No, a slightly yellow appearance does not affect the performance of the additive as long as the tubes are used before their expiration date.

FAQ ID - 4050

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.

FAQ ID - 4048

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.

FAQ ID - 4053

FAQ ID - 4049

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.

FAQ ID - 4041

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.

FAQ ID - 4064

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.

FAQ ID - 4062

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.

FAQ ID - 4047

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.

FAQ ID - 4059

FAQ ID - 4058

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 <i>PAXgene Urine Liquid Biopsy Set Handbook</i>
available under resources on www.preanalytix.com

FAQ ID - 4063

The shelf life of the set is 12 months from the date of manufacture. The expiration date is printed on the set label.

FAQ ID - 4051

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.

FAQ ID - 4061

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.
Furthermore, 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.

FAQ ID - 4046

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.

FAQ ID - 4057

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.

FAQ ID - 4056

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

FAQ ID - 4060

FAQ ID - 4055

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.

FAQ ID - 4042

Yes. Further information can be found in the PAXgene Urine Liquid Biopsy Set Handbook accessible under the Resources tab on www.preanalytix.com.

FAQ ID - 4040

Yes. Further information on ordering additional tubes can be found under Other Products Used in Conjunction on www.preanalytix.com.

FAQ ID - 4045

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.

FAQ ID - 4054