Orsin Medical Technology – Gel & Clot ActivatorExtraction & Analysis Solutions

1,Product Description:

     Orsin Medical's Gel & Clot Activator represents the gold standard in blood collection technology, engineered to deliver faster, cleaner serum separation for precision diagnostics. Our patented gel formulation and optimized clot activator work synergistically to:

✔ Accelerate clotting (15-30 min) without compromising sample integrity
✔ Ensure pure serum yield with our advanced barrier gel (<1% cellular contamination)
✔ Maximize lab efficiency by reducing processing time and centrifugation steps
✔ Support diverse tests - from routine chemistry to specialized immunoassays

2, Fundamental Parameters

3,Applications

• Category	Specification
  Clotting Performance	15-30 min (ambient temp); 10-20 min (37°C accelerated protocol)
  Gel Properties	Density: 1.045±0.005 g/cm³; Thermal range: -20°C to 40°C
  Centrifugation Protocol	1300-1500 × g for 10 min (standardized separation protocol)

  2.1. Quality Metrics

  Parameter	Acceptance Criteria	Testing Standard
  Serum Recovery Rate	≥95%	CLSI H18-A4
  Hemolysis Index	≤1% (Visual Index ≤100)	NCCLS H20-A
  Cellular Contamination	≤0.1%	Microscopic Evaluation

  2.2. Product Configuration

  Feature	Specification
  Available Volumes	1-10mL
  Draw Volume Accuracy	±5% of nominal volume
  Tube Construction	PET material with Hemogard™ closure system

  2.3. Regulatory Compliance

  Standard	Compliance Status
  Sterility Assurance	SAL 10⁻⁶
  Endotoxin Levels	<0.05 EU/mL (USP <85>)
  Shelf Life Validation	24 months (accelerated aging studies)

  2.4. Operational Guidelines

  Condition	Requirement
  Storage Temperature	4-30°C (maintain gel integrity)
  Freezing Conditions	Prohibited (causes gel barrier compromise)
  Clinical Applications	Compatible with major chemistry/immunoassay platforms

3.1 Clinical Chemistry

• Metabolic Panels (Liver/Kidney function, Electrolytes)

• Lipid Profiling (Cholesterol, Triglycerides, HDL/LDL)

• Endocrine Testing (Glucose, HbA1c, Insulin)

3.2  Immunology & Serology

• Infectious Disease Testing (HIV, Hepatitis, Syphilis, COVID-19 Antibodies)

• Autoimmune Markers (RF, CRP, ANA, Anti-CCP)

• Allergy & Hormone Assays (IgE, TSH, Cortisol )

3.3.Therapeutic Drug Monitoring (TDM)

• Immunosuppressants (Cyclosporine, Tacrolimus)

• Antiepileptics (Phenytoin, Valproate)

• Antibiotics (Vancomycin, Gentamicin)

3.4 Toxicology & Oncology

• Drug Abuse Screening (Opioids, Amphetamines, Cannabinoids)

• Tumor Markers (PSA, CEA, CA 19-9, AFP)

3.5 Specialized Testing

• Cardiac Markers (Troponin, CK-MB, BNP)

• Vitamins & Trace Elements (Vitamin D, B12, Ferritin)

• Molecular Diagnostics (PCR-based assays)

3.6Research Use

• Biobanking (Long-term serum storage)

• Preclinical Studies (Animal model research)

• Assay Development (IVD kit validation)

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Key Advantages for Laboratories:
✔ Wide test compatibility – Validated for 200+ assays
✔ Reduced sample prep time – Faster turnaround for STAT tests
✔ Superior sample quality – Minimal interference in sensitive assays