CPT Tubes / PBMC Isolation Tubes (Cell Preparation Tubes)

Product Overview

Manufactured under strict ISO 13485 quality management systems and certified as a China NMPA Class II Medical Device, XINLE CPT Tubes (Cell Preparation Tubes) revolutionize peripheral blood mononuclear cell (PBMC) separation.

Traditional manual Ficoll density gradient separation requires complex, open-tube multi-step pipetting, highly experienced technicians, and prolonged processing times. Our CPT tubes integrate whole blood collection, density gradient layering, and sterile cell separation into a single, direct-draw closed system. Upon a single centrifugation step, an inert polyester gel barrier moves to separate mononuclear cells and plasma from denser erythrocytes and granulocytes, ensuring consistent, sterile, and reproducible PBMC isolation across multi-center clinical trials.

Regulatory Notice: NMPA Class II Certified Medical Device for Clinical Immunology & Cell Therapy Research.

Key Features & Biological Advantages

• One-Step Centrifugation Isolation: Directly isolates high-purity PBMCs in a single 20-minute centrifugation step, eliminating tedious manual Ficoll layering and reducing hands-on preparation time by over 70%.
• Superior Cell Viability & Recovery: Optimized density gradient medium delivers a PBMC recovery rate ≥82%, cell purity ≥98%, and cell viability ≥99%, perfectly preserving natural cell surface markers and biological functions.
• Closed Sterile System: Blood collection, cell separation, and temporary storage occur in the original closed tube, eliminating sample exposure and minimizing cross-contamination and biohazard risks.
• Flexible 24-Hour Room Temperature Holding: Whole blood specimens can be maintained upright in the tube at room temperature (18–25°C) for up to 24 hours prior to centrifugation, providing unmatched flexibility for clinical trial logistics.
• Dual Anticoagulant Formulations: Available in CPT-A (Sodium Citrate) and CPT-B (Sodium Heparin) to match specific downstream diagnostic and cellular assay requirements.
• Standardized & Traceable Quality: Eliminates technician-to-technician variability, ensuring reproducible cell yields essential for clinical immunology and biobanking.

Clinical & Cellular Therapy Applications

Isolated PBMCs are widely utilized across immunology, oncology, cell therapy, and molecular diagnostics:

• Immune Cell Therapy Manufacturing: Providing high-viability starting cell sources (T cells, NK cells, monocytes) for CAR-T, TCR-T, and autologous NK cell immunotherapies.
• HLA Tissue Typing: Donor-recipient Human Leukocyte Antigen (HLA) typing and cross-matching in solid organ and bone marrow transplantation.
• Minimal Residual Disease (MRD) Testing: Residual leukemia gene detection and post-treatment recurrence monitoring.
• Flow Cytometry & Immunophenotyping: High-resolution lymphocyte subset profiling (CD3, CD4, CD8, CD19, CD56) and immune status evaluation.
• Cytokine Release & Vaccine Assays: Antigen-specific immune response evaluation, cytokine secretion assays, and vaccine efficacy research.
• Functional Cellular Assays: Primary cell culture, proliferation assays, and gene-expression studies.

Product Specifications & Packaging

Certification: China NMPA Class II Medical Device Certified.

Operation Guide: Centrifugation & Harvesting Protocol

Follow this standardized operational protocol for optimal mononuclear cell separation:

1. Blood Draw: Perform routine venipuncture using a standard venous needle. Fill the CPT tube completely to its designated draw volume (4 mL or 8 mL).
2. Immediate Inversion: Gently invert the tube 8 to 10 times immediately after blood draw to thoroughly mix whole blood with the anticoagulant and density gradient medium.
3. Pre-Centrifugation Holding: Store the tube vertically upright at room temperature (18–25°C). Centrifugation within 2 hours of collection is recommended for optimal separation yield.
4. Centrifugation Parameters: Centrifuge at 1500–1800 × g for 20 minutes at 18–25°C in a swinging-bucket rotor centrifuge with the brake off or set to slow deceleration.
5. Layer Formation: Post-centrifugation, the gel barrier seals off red blood cells and granulocytes at the bottom. The mononuclear cell (PBMC) layer appears as a distinct, whitish, cloudy band immediately beneath the clear plasma layer above the gel.
6. Harvesting: Aspirate the plasma layer, then collect the cloudy PBMC band using a sterile pipette for downstream washing or cell culture.

Frequently Asked Questions (FAQ)