Product Description: Cell-Free DNA (cfDNA) Collection and Preservation System by Orsin Medical Technology

• 1. Product Description

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• Orsin Medical Technology’s Cell-Free DNA (cfDNA) Collection and Preservation System offers a reliable, non-invasive solution for the efficient stabilization and transport of high-quality cfDNA samples. Designed for clinical research, liquid biopsy, and molecular diagnostics, our proprietary technology ensures the integrity of cfDNA from blood samples, minimizing degradation and contamination.

  Key Features:
  ✔ Room-Temperature Stability – Eliminates the need for cold chain transport, reducing costs and logistical challenges.
  ✔ High Yield & Purity – Preserves cfDNA fragments for accurate downstream analysis (NGS, PCR, etc.).
  ✔ Clinically Validated – Optimized for compatibility with major diagnostic platforms.
  ✔ User-Friendly – Simple blood collection and seamless integration into lab workflows.

  Ideal for cancer screening, prenatal testing, and disease monitoring, Orsin’s cfDNA system empowers precision medicine with robust, reproducible results.

• 2. Specification

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  Parameter	Description/Options
  Tube Cap Color	Red, Lavender (Purple), Green, Gray, Blue, Yellow, Black, etc.
  Additive Type	None (Clot activator), EDTA, Heparin, Sodium Citrate, Sodium Fluoride, etc.
  Clinical Use	Serum separation, Hematology, Coagulation, Chemistry, Glucose, Blood Bank, etc.
  Nominal Volume	2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 10ml, etc.
  Draw Volume Range	±10% of nominal volume (e.g., 4.5-5.5ml for 5ml tube)
  Tube Diameter	13mm, 16mm (standard adult size)
  Tube Length	75mm, 100mm, etc.
  Material	PET plastic, Glass
  Sterilization	Gamma irradiation, EO Gas
  Expiry Period	Typically 12-36 months (from date of manufacture)
  Hemolysis Rate	≤0.1% (for most chemistry tubes)
  Clotting Time	30 mins (for serum tubes with clot activator)
  Centrifuge Speed	1300-2200g (tube material dependent)
  Safety Features	Hemogard™ closure, BD-PTS, Needle protection system
  Certifications	ISO 6710, CE Marked, FDA 510(k)

  Common Parameters by Tube Color (Example):

  Cap Color	Additive	Mixing	Inversion Count	Clinical Applications
  Red	None/Clot activator	5×	5-6	Serum chemistry, Immunology
  Lavender	K2/K3 EDTA	8-10×	8-10	Hematology (CBC, Blood Smear)
  Green	Lithium Heparin	8-10×	8-10	Plasma chemistry, STAT tests
  Gray	NaF/K Oxalate	8-10×	8-10	Glucose tolerance, Alcohol tests
  Blue	Sodium Citrate	3-4×	3-4	Coagulation tests (PT, APTT)

  3 . Application

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  1. Oncology & Cancer Management

• Early Cancer Detection – Isolate tumor-derived cfDNA (ctDNA) for multi-cancer screening (e.g., lung, breast, colorectal).

• Minimal Residual Disease (MRD) Monitoring – Track recurrence post-surgery/chemotherapy with high sensitivity.

• Therapy Selection & Resistance – Profile mutations (e.g., EGFR, KRAS) to guide targeted therapies.

• Liquid Biopsy – Alternative to invasive tissue biopsies for metastatic or hard-to-access tumors.

• Compatible Tests: NGS panels, ddPCR, methylation profiling.

  2. Prenatal & Reproductive Health

• Non-Invasive Prenatal Testing (NIPT) – Detect fetal chromosomal abnormalities (e.g., trisomy 21, 18, 13) from maternal blood.

• Preimplantation Genetic Testing (PGT) – Support IVF embryo screening.

• Preeclampsia Risk Assessment – Analyze placental cfDNA for early预警.

• 3. Transplant Medicine

• Organ Rejection Monitoring – Detect donor-derived cfDNA (dd-cfDNA) in transplant recipients (e.g., kidney, heart, liver).

• Graft-versus-Host Disease (GVHD) – Monitor post-hematopoietic stem cell transplantation (HSCT).

• Pathogen Detection – Identify microbial cfDNA in sepsis or occult infections (e.g., TB, CMV).

• Autoimmune Disease Research – Study cfDNA release patterns in lupus, rheumatoid arthritis, etc.

• 5. Neurological & Chronic Diseases

• Neurodegenerative Disorders – Investigate cfDNA biomarkers for Alzheimer’s, Parkinson’s.

• Cardiovascular Risk – Correlate cfDNA levels with myocardial injury or stroke.

• 6. Research & Drug Development

• Biomarker Discovery – Explore novel cfDNA signatures for diagnostics/therapeutics.

• Clinical Trials – Standardize sample collection for multicenter studies.

• 4. Infectious Diseases & Immunology

• Pathogen Detection – Identify microbial cfDNA in sepsis or occult infections (e.g., TB, CMV).

• Autoimmune Disease Research – Study cfDNA release patterns in lupus, rheumatoid arthritis, etc.

• 5. Neurological & Chronic Diseases

• Neurodegenerative Disorders – Investigate cfDNA biomarkers for Alzheimer’s, Parkinson’s.

• Cardiovascular Risk – Correlate cfDNA levels with myocardial injury or stroke.

• 6. Research & Drug Development

• Biomarker Discovery – Explore novel cfDNA signatures for diagnostics/therapeutics.

• Clinical Trials – Standardize sample collection for multicenter studies.