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

  • 1. Product Description

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  • Product Description

  • A specialized disposable liquid biopsy test tube designed for Preimplantation Genetic Testing (PGT) in clinical trials, engineered to preserve cell-free DNA (cfDNA) and embryo-derived genetic material with minimal degradation. Its inert material and optimized preservative system (where applicable) ensure high-integrity DNA samples, supporting accurate genetic sequencing and analysis critical for PGT applications.
  • This clinical trial-grade liquid biopsy tube integrates DNA stabilization technology to maintain the integrity of PGT-relevant genetic material during collection, transport, and storage. Compatible with standard molecular biology workflows, it facilitates reliable isolation and amplification of cfDNA, making it a key tool for reproductive genetics research and clinical trial protocols.

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  • 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 .

    Applications

  • Preimplantation Genetic Testing (PGT) in clinical trials, including PGT-A (aneuploidy), PGT-M (monogenic disorders), and PGT-SR (structural rearrangements).
  • Liquid biopsy-based genetic analysis of embryo culture media or maternal blood for non-invasive PGT research.
  • Reproductive genetics clinical trials requiring high-fidelity DNA preservation and traceable sample handling.
  • Academic research institutions and contract research organizations (CROs) conducting studies on embryo genetics and assisted reproductive technology (ART).

Packaging & Shipping

1. Primary Packaging: Each tube is individually wrapped in a sterile, foil-lined pouch to protect against light and moisture, with a barcode for lot tracking and sample identification.
2. Secondary Packaging: 50 or 100 tubes per rigid plastic tray with foam dividers, labeled with product name, PGT compatibility, and storage conditions. Trays are sealed with sterile, peelable film.
3. Master Cartons: Trays are packed into UN-certified corrugated cartons with thermal insulation (for temperature-sensitive variants) and shock-absorbent padding. Cartons include batch certificates, sterility reports, and clinical trial compliance documentation.
4. Storage Conditions: Store unopened at 15–30°C (ambient-stable variants) or 2–8°C (preservative-sensitive variants) with a shelf life of 18 months from manufacture. Avoid freezing or exposure to direct sunlight.
5. Shipping Requirements: Shipped in temperature-controlled containers (for cold-chain variants) with "Biological Substance, Category B" labeling per IATA regulations. Include a packing list with lot numbers and compliance certificates for customs clearance.