Shanghai Orsin Medical Technology Co., Ltd.
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1. Product Description
The Cell-Free DNA (cfDNA) Testing Kit developed by Orsin Medical Technology is a cutting-edge solution for the isolation, quantification, and analysis of cell-free DNA from various biological fluids, including plasma, serum, and other liquid biopsy samples. Our kit utilizes advanced technology to ensure high sensitivity, specificity, and reproducibility, making it an ideal tool for clinical diagnostics, cancer screening, prenatal testing, and research applications.
2. Specification
| 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) |
| Application | Sensitivity | Specificity | PPV | NPV | LoD |
|---|---|---|---|---|---|
| NIPT T21 | >99% | >99.9% | >90% | >99.9% | 2-4% FF |
| ctDNA MRD | 0.01% VAF | 95-99% | 80% | 98% | 0.1% MAF |
| dd-cfDNA | 85-92% | 78-85% | 75% | 90% | 0.5% |
Oncology & Liquid Biopsy – Detect tumor-derived cfDNA for early cancer screening, treatment response monitoring, and minimal residual disease (MRD) assessment with reduced sample degradation.
Non-Invasive Prenatal Testing (NIPT) – Ensure high fetal cfDNA recovery for accurate aneuploidy and genetic disorder screening.
Ideal for hospitals, reference labs, and biotech R&D, our tubes bridge the gap between sample collection and precision analysis—delivering consistency from clinic to lab.
Transplant Medicine – Monitor donor-derived cfDNA (dd-cfDNA) to assess graft rejection risk without invasive procedures.
Infectious Disease & Sepsis – Improve pathogen detection in bloodstream infections through enhanced microbial cfDNA preservation.Longitudinal Studies & Biobanking – Stabilize samples for large-scale genomic research with room-temperature storage convenience.