Multi-Sample Blood Collection Needles (Pen Needles)
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Product Overview
Manufactured under strict ISO 13485 quality management systems and certified as a China NMPA Class II Medical Device, XINLE Cell-Free RNA Collection Tubes (cfRNA BCT) provide an advanced pre-analytical stabilization solution for liquid biopsy, non-invasive prenatal testing (NIPT), and precision oncology research.
Circulating cfRNA profiles are closely linked to tumor tissue gene expression patterns, providing highly sensitive and specific biomarkers for differentiating benign from malignant lesions and detecting tumor micrometastasis. Our proprietary stabilization chemistry rapidly inactivates plasma RNase activity and prevents nucleated blood cells from lysing, eliminating the need for immediate cold-chain transport or urgent on-site centrifugation.
Regulatory Notice: NMPA Class II Certified Medical Device for Molecular Diagnostic & Clinical Research Use.
Core Features & Proprietary Stabilization Advantages
- ≥7 Days Room Temperature Preservation: Maintains the stability, integrity, and concentration of circulating cell-free RNA in whole blood for at least 7 days at ambient temperature (10–30°C), supporting flexible logistics without cold-chain dependence.
- Advanced Plasma RNase Inhibition: Instantly suppresses active plasma RNase enzymes to protect ultra-fragile circulating free RNA molecules from enzymatic degradation.
- Suppression of Background RNA Interference: Chemically stabilizes white blood cell membranes to prevent cell lysis and the subsequent release of non-target intracellular RNA and endogenous RNases, ensuring high signal-to-noise ratio in molecular assays.
- Extended Pre-Analytical Processing Window: Unlike conventional EDTA tubes (which show sudden spikes in background RNA within hours of collection), cfRNA BCT preserves true biological expression profiles over an extended multi-day window.
- Universal Downstream Molecular Compatibility: Preserved cfRNA, ctRNA, and exosomal RNA specimens are fully compatible with digital droplet PCR (ddPCR), RT-PCR, and next-generation RNA sequencing (RNA-Seq/NGS).
- High-Quality Manufacturing & Regulatory Clearance: Approved by the National Medical Products Administration (NMPA Class II) and manufactured under rigorous ISO 13485 cleanroom controls for batch-to-batch traceability.
Clinical & Molecular Diagnostic Applications
XINLE cfRNA BCTs are widely utilized across translational genomics, reproductive genetics, and clinical oncology:
- Oncology Liquid Biopsy & Early Cancer Screening: Collecting circulating tumor RNA (ctRNA) and microRNA (miRNA) for tumor burden quantification, therapeutic response tracking, and drug-resistance biomarker discovery.
- Tumor Micrometastasis & Prognostic Monitoring: Profiling transcriptomic biomarkers associated with minimal residual disease (MRD) and early tumor recurrence.
- Non-Invasive Prenatal Testing (NIPT): Preserving fetal-derived circulating RNA biomarkers from maternal peripheral blood for advanced prenatal molecular studies.
- Exosome & Extracellular Vesicle (EV) Research: Stabilizing vesicular membranes and internal RNA cargo, supporting downstream exosomal biomarker isolation.
- Pharmacogenomics & Precision Medicine: Longitudinal gene expression analysis and pharmacogenomic monitoring in clinical drug trials and biobanking.
Product Specifications & Packaging
| PRODUCT/MATERIAL | Tube Size | Volume | Additive | Shelf Life | PACKAGING (INNER BOX / CARTON) |
| cfRNA Collection Tube（GLASS） | 13×100mm | 5ml | K2EDTA+ Proprietary RNA Stabilizer | 12 months | 100pcs/1200pcs |
| cfRNA Collection Tube（GLASS） | 16×100mm | 10ml | K2EDTA+ Proprietary RNA Stabilizer | 12 months | 100pcs/1200pcs |
How to Use cfRNA Collection Tubes
Follow these standardized handling procedures to ensure complete RNA stabilization:
- Blood Draw: Perform routine venipuncture using a standard venous blood collection needle.
- Ensure Complete Draw: Fill the tube to its designated vacuum draw volume (5 mL or 10 mL) to maintain the exact blood-to-stabilizer formulation ratio.
- Immediate Inversion Mixing: Gently invert the tube several times (8 to 10 times recommended) immediately after blood collection to ensure thorough mixing of whole blood with the pre-loaded RNA stabilizer. (Do not shake vigorously).
- Ambient Storage & Transport: Store and transport whole blood specimens at room temperature (10–30°C). No dry ice, freezing, or immediate plasma separation is required during shipping.
Frequently Asked Questions (FAQ)
A: Regular EDTA tubes contain only an anticoagulant. When stored at room temperature, white blood cells in whole blood quickly lyse and release large quantities of cellular RNA and intracellular RNases, leading to a massive increase in non-target background RNA that masks target biomarkers. XINLE cfRNA collection tubes are pre-loaded with proprietary RNA stabilizers that actively inhibit plasma RNase activity while stabilizing blood cell membranes, keeping circulating cell-free RNA stable at room temperature for at least 7 days without background cellular RNA contamination.
A: Gently invert the tube several times immediately after collection to ensure thorough, uniform mixing of the whole blood with the pre-loaded K2EDTA anticoagulant and proprietary RNA stabilizer.
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