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Product Overview
Manufactured under strict ISO 13485 quality management systems, the XINLE Urine DNA Collection Kit provides an advanced, contamination-free pre-analytical solution for molecular diagnostic laboratories, urology centers, and biobanks.
Urine contains complex bio-components, with endogenous DNase I activity hundreds of times higher than that found in blood serum, causing rapid enzymatic hydrolysis of fragile nucleic acids. Furthermore, unpreserved exfoliated nucleated cells rupture easily during transport, releasing unwanted genomic background DNA that dilutes target biomarker signals. Our proprietary preservation formulation rapidly arrests urinary nucleases and stabilizes exfoliated cell membranes, maintaining intact cfDNA and gDNA architecture under ambient indoor temperatures without refrigeration or dry ice.
Regulatory Notice: Sterile, Closed-System Medical Consumable for In Vitro Molecular Diagnostic Sampling.
Key Features & Biological Advantages
- Potent High-Endogenous DNase I Inhibition: Proprietary enzyme inhibitors instantly suppress high-concentration urinary nucleases, preventing enzymatic breakdown and preserving low-abundance target DNA fragments.
- Exfoliated Cell Membrane Stabilization: Chemically locks the membrane structures of exfoliated urinary tract cells, preventing cell lysis, leakage of intracellular genomic DNA into the supernatant, and target dilution.
- Broad-Spectrum Microbial Growth Suppression: Urine is prone to rapid bacterial proliferation; our preservative actively inhibits microbial growth to prevent bio-contamination and sample spoilage during transport.
- Cold-Chain-Free Room-Temperature Logistics: Preserved urine specimens maintain structural DNA integrity under normal ambient indoor temperatures, eliminating cold storage, dry ice, and cold-chain shipping costs.
- Closed-System Vacuum Transfer Design: Integrated vacuum collection technology allows urine to be transferred directly from the collection cup into the evacuated tube without opening caps, eliminating spills, odor, and biohazard exposure.
- Full Sterile Matching Components: Supporting collection cups, vacuum tubes, and HDPE bottles are Ethylene Oxide (EO) sterilized, certified DNase-free, RNase-free, and pyrogen-free.
- Universal Downstream Molecular Compatibility: Preserved samples are 100% compatible with commercial magnetic bead and column-based cfDNA extraction kits, automated liquid handlers, qPCR, digital PCR (dPCR), and Next-Generation Sequencing (NGS).
Clinical, Liquid Biopsy & Research Applications
The Urine DNA Collection Kit is widely utilized across clinical urology, oncology, and reproductive genetics:
- Urological Oncology Liquid Biopsy: Non-invasive collection for tumor-derived cfDNA mutation detection, methylation marker screening, and recurrence monitoring in bladder cancer, renal cell carcinoma (RCC), and prostate cancer.
- Non-Invasive Prenatal Testing (NIPT / NIPS): Collecting fetal cfDNA from maternal urine to screen for fetal chromosomal aneuploidies and monogenic disease risks without blood draws.
- Renal Transplant Rejection Surveillance: Monitoring donor-derived cell-free DNA (dd-cfDNA) in recipient urine for early, non-invasive detection of allograft injury and acute rejection.
- Urinary Infectious Disease & Pathogen Detection: Sampling microbial cell-free DNA for metagenomic NGS (mNGS) and targeted PCR screening of complex urinary tract infections (UTIs).
- Pharmacogenomics & Personalized Medicine: Evaluating genetic polymorphisms in urinary tract cells to predict drug efficacy and adverse toxicity profiles.
- Large-Scale Population Biobanking & Cohort Studies: Painless, non-invasive home or field sample collection with high donor compliance.
Product Specifications & Packaging Configurations
| Kit Configuration | Container Component | Material | Tube/Bottle Size | Volume | Pre-loaded Additive | Shelf Life | Packaging |
| PET Tube Kit | Urine DNA Tube + Urine Cup | PET / PP | 16 × 100 mm | 10 mL (Cup: 80 mL) | K2EDTA + DNA Stabilizer | 12 Months | 100 pcs/carton |
| Glass Tube Kit | Urine DNA Tube + Urine Cup | Glass / PP | 16 × 100 mm | 10 mL (Cup: 80 mL) | K2EDTA + DNA Stabilizer | 12 Months | 100 pcs/carton |
| HDPE Bottle Kit | Urine Bottle + Urine Cup | HDPE / PP | Bottle Container | 100 mL (Cup: 150 mL) | K2EDTA + DNA Stabilizer | 12 Months | 100 pcs/carton |
Sterilization: EO Sterilized, Certified DNase-Free, RNase-Free, Pyrogen-Free.
How to Use the Urine DNA Collection Kit
Follow these standardized operational steps for clean, closed-system sampling:
- Urine Voiding: Collect fresh urine into the provided sterile collection cup (recommended collection volume is 30–80 mL, with 60 mL being optimal).
- Closed Vacuum Transfer:
For Vacuum Tubes (10 mL): Insert the evacuated collection tube into the cup’s integrated transfer port. The vacuum will automatically draw the exact 10 mL volume into the tube without removing the stopper.
For HDPE Bottles (100 mL): Pour the urine into the pre-filled preservative bottle up to the fill mark and tighten the cap securely. - Immediate Inversion Mixing: Gently invert the sample tube or bottle 5 to 10 times immediately after collection to ensure thorough mixing of urine with the pre-loaded stabilizer.
- Ambient Shipping: Store and transport the sealed container at ambient room temperature directly to the molecular testing facility.
Frequently Asked Questions (FAQ)
A: This kit effectively and simultaneously preserves two major types of DNA present in urine:
- Genomic DNA (gDNA) within intact nucleated exfoliated cells from the urinary tract;
- Circulating Cell-Free DNA (cfDNA) derived from systemic circulation or localized tumor cell turnover.
A: The recommended clinical collection volume is 30 to 80 mL, with approximately 60 mL being optimal to ensure adequate cellular and cfDNA yields for downstream molecular assays.
A: Gently invert the collection tube or bottle 5 to 10 times immediately after collection. Thorough inversion ensures the pre-loaded K2EDTA and specialized DNA stabilization reagents completely blend with the urine, instantly neutralizing endogenous DNases and stabilizing cell membranes.
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