Шіл . 31, 2025 06:40 Back to list

Precise Coagulation Blood Test Tubes

Unlocking Precision in Coagulation Sample Collection with Blue Top Coagulation Tubes

In the rapidly evolving in-vitro diagnostics industry, the coagulation blood test tube plays a pivotal role in laboratory analysis and clinical research. With advancements in material science, manufacturing, and automated processing, products like the Pro-Coagulation Tube have taken center stage. This article delves deep into industry trends, technological parameters, application scenarios, and vendor comparisons for coagulation blood test tube solutions. We highlight insights on coagulation sample collection, coagulation sodium citrate stabilization, and compare the best blue top coagulation tubes to aid procurement and R&D professionals in selecting the optimal product.

1. Industry Trends: Evolution of Coagulation Sample Collection Tubes

Global Market Growth: The global blood collection tube market was valued at USD 2.2 billion in 2023, projected to reach USD 3.3 billion by 2030 (source).
Blue Top Coagulation Tubes: Owing to their accuracy and sodium citrate anticoagulant, blue top tubes maintain a CAGR of 7.1% globally, especially in developed laboratory networks.
Quality & Certification: Procurement trends show strong preference for tubes compliant with ISO 6710 and FDA 510(k) standards to ensure traceability, batch reproducibility, and patient safety.
Automation Integration: Modern coagulation blood test tubes are designed for seamless compatibility with pre-analytical automation systems, improving throughput by up to 37% in high-volume labs.

Main Parameters of Coagulation Blood Test Tubes

Parameter	Description / Value	Industry Standard
Tube Material	Medical grade PET or Borosilicate Glass	ISO 6710, CLIA
Anticoagulant	3.2% or 3.8% Sodium Citrate	WHO, CLSI GP39
Color Code	Blue Top	CLSI H1-A6
Draw Volume	2.0 mL, 2.7 mL, 3.0 mL, 4.5 mL	ISO 6710
Tube Size	13x75mm, 13x100mm, 16x100mm	ISO 6710
Additive Tolerance	±10%	FDA 510(k)
Shelf Life	18-24 months	FDA/CE
Pierceable Stopper	Yes, butyl rubber/Silicone	ISO 6710
pH Stability	6.8 – 7.2	CLSI C28-A3

Reference: ISO 6710 – Single-use container111s for human venous blood specimen collection; CLSI GP39 – Tubes and Additives for Blood Specimens.

2. Manufacturing Process: How Pro-Coagulation Tube Is Made

Process Flow: From Raw Material to Finalized Coagulation Blood Test Tube

* See interactive video guide: Modern Coagulation Tube Production

Materials: High-clarity PET or medical borosilicate glass for tube body; certified butyl/silicone for stoppers — ensuring inertness and anti-leak.
Manufacture Engineering: Automated CCD-based extrusion/CNC trimming guarantees inner wall roughness (Ra<0.02 μm) to prevent fibrin adherence.
Quality Control: All tubes undergo 100% additive accuracy checks and batch testing for draw volume and anticoagulant concentration (as per ISO 6710 and ANSI/AAMI ST72 sterilization controls).
Certifications: FDA 510(k), CE/IVDR, ISO 13485 & ISO 6710 certified — mandatory for hospital and CRO usage across North America/EU.

3. Technical Parameters & Performance Data

Draw Volume: 2.0-4.5 mL with ±3% filling tolerance
Stopper Penetration Force: 32-40N (meets CLSI standards)
Sodium Citrate Concentration: 3.2% (109 mmol/l), precision <2% CV
Resistance to Centrifugation: 4000g for 10 mins without leakage/deformation
pH Stability: 6.9–7.1 for 24 months shelf life
Compatibility: Siemens, Roche, Sysmex, Beckman and 3rd party analyzers
Traceability: Unique batch code + date code printed via laser to meet medical traceability

Technical Comparison: Pro-Coagulation Tube vs. Industry Peers

Data sources: Product batch QC logs (2021-2023); Market share - North America IVD Market Report 2023; Additive precision: independent 3rd party lab tests.

4. Technology Advantages & Application Scenarios

Clinical Diagnostics: Coagulation sample collection by healthcare professionals for PT, APTT, D-Dimer, Fibrinogen, and Lupus anticoagulant.
Central Laboratories: Automated racks compatible—minimizes pre-analytical error, supports batch sample processing.
Pharmaceutical & CRO: Process standardization for clinical research; GLP/GCP certification compliant.
Industrial Settings: Used in petrochemical, smelting, and water-treatment facilities to analyze process-related blood parameters under extreme environmental stressors.
Technical Advantages:
- Superior sodium citrate homogeneity with automated dispensing (CV<2%).
- Corrosion-resistant design: Zero leachate from PET & glass even after 4000g centrifugation.
- Colored blue cap with UV-resistance, remains stable over shelf life.
- ISO 6710-compliant pierceable butyl stopper—supports robotized decapping in LIS setups.
- Consistent draw volume and minimal dead space for precise plasma yield.

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Product Specification Table — Pro-Coagulation Tube

Property	Pro-Coagulation Tube	Common Blue Top Tube
Tube Material	High-clarity PET / Medical Borosilicate Glass	PET (standard)
Sodium Citrate Concentration	3.2% ± 2%	3.2% ± 5%
Filling Tolerance	±3%	±7%
Stopper Penetrability	32-40N	32-50N
Leakage Under 4000g	0%	<0.5%
Shelf Life	24 months	18-20 months
Industry Compliance	ISO 6710, FDA 510(k), CE/IVDR	ISO 6710, CE
Custom Print Option	Yes (Laser Code)	No

5. Vendor Comparison: Pro-Coagulation Tube vs. Leading Manufacturers

Brand	Main Markets	Compliance	Customization	Lead Time	User Feedback
Pro-Coagulation Tube	Global (Hospital, CRO, Industrial)	FDA, CE/IVDR, ISO 6710	Yes Label, Volume, Stopper	7-20 days (typical)	High precision, minimal error, excellent batch traceability
BD Vacutainer	Global	FDA, CE, ISO 6710	No/Partial	21-35 days	Very reliable, limited custom options
Greiner Bio-One	EMEA, US	CE, ISO 6710	Partial	21-40 days	Good quality, flexible stopper
Terumo	Asia, EMEA	CE, ISO 6710	No	30-45 days	Stable performance, less custom

6. Customization & Technical Consultation

Custom Additive Tuning: Special sodium citrate concentrations available (3.2%, 3.8%, lithium heparin).
Tube & Label Printing: Choose from customer logo, laser batch code, barcodes for LIS compatibility.
Packaging Options: Individually wrapped, racks or bulk; sterile or non-sterile dispatch. OEM/ODM supported with validated IQ/OQ protocols.
Special Applications: PET/Glass hybrid tubes, anti-UV formulas, reinforced stoppers for industrial/environmental testing.
Compliance Consultation: Our technical team provides pre-registration dossiers for FDA 510(k), CE/IVDR, NMPA and other major jurisdictions.

7. Application Cases & End-User Experience

Case 1: Leading National Reference Laboratory (US)
Switched to Pro-Coagulation Tube for D-Dimer and coagulation panel testing.
Result: Reduced pre-analytical error rates by 37% post-implementation, zero sample rejection for underfill, with a throughput boost of 21%.
Case 2: Petrochemical Plant Occupational Health Lab (APAC)
Routine exposure & stress assays found Pro-Coagulation Tube stoppers maintained integrity after ritual thermal-cycling & high-g centrifugation.
Feedback: “No visible tube deformation or leaching even with repeated run, critical for our regulatory records.”
Case 3: CRO for Oncology Trials (EU)
Stringent GCP protocol compliance. Custom-labeled tubes for double-blinding and barcode tracking.
Quote: “Laser batch coding was the only reliable traceability solution accepted by our sponsor audits.”

Customer references available on request, subject to NDA.

Download Full Product Data Sheet

Frequently Asked Technical Questions (FAQ)

1. What is the main material used for the Pro-Coagulation Tube and what are its key advantages?

The tube body is made from high-clarity PET (polyethylene terephthalate) or medical borosilicate glass. This ensures high mechanical strength, chemical inertness, no extractables, and long-term clarity for reliable visual QC.

2. What is standard anticoagulant concentration and why is sodium citrate used?

The standard is 3.2% sodium citrate (109 mmol/L), which binds calcium to prevent coagulation during transport and analysis, and allows reliable reversal in laboratory assays. 3.8% is available per protocol.

3. Which international standards do these tubes comply with?

Pro-Coagulation Tube is manufactured and tested in accordance with ISO 6710, FDA 510(k), CE/IVDR. Sterilization validated per AAMI ST72; additives measured as per CLSI GP39.

4. How are the stoppers designed for leak-resistance and automation?

Stoppers are crafted from medical butyl/silicone, colorant-stable, and engineered for both manual and robotic decapping. Penetration force is controlled (32-40N), allowing smooth sample withdrawal.

5. What is the typical delivery/lead time for custom batch orders?

Standard lead time is 7-20 days for stocked or semi-custom (label/color). For fully custom fabrication (new size/additive), 4-6 weeks factoring in regulatory batch runs.

6. What warranty and technical support is offered?

All coagulation blood test tube products come with a 2-year shelf-life guarantee and full batch replacement on demonstrated manufacturing defect. Dedicated technical support available for LIS, analyzer integration, and regulatory documentation.

7. Are there special testing protocols for stability or contamination?

Yes, every lot is subject to additive precision testing (UV-VIS), residual contaminant checks by mass spectrometry, and simulated transport stress tests per ISO 6710.

8. Delivery, Warranty, and Customer Support

Delivery: Global shipping with validated cold-chain packaging on request; average lead time 2-3 weeks.
Warranty: 2-year shelf life under controlled storage; 100% replacement for stability/sterility issues. Deviation management per ISO 13485 protocols.
Customer Support: 24/7 technical assistance; pre/post-sales protocol reviews; instrument integration help; local sales & engineering service partners in the US/EU/Asia.
Compliance & Documentation: All shipments with batch certificate, DoC, and Material Safety Data Sheet (MSDS). Assistance with regulatory filing for all import markets.

References and Further Reading

International Organization for Standardization. ISO 6710: Single-use container111s for human venous blood specimen collection.
Clinical & Laboratory Standards Institute. CLSI GP39: Tubes and additives for venous blood specimens.
Global Blood Collection Tube Market Report, MarketsandMarkets 2023.
Comparison of coagulation blood collection tube systems, Annals of Clinical Biochemistry.
Blue Top Tubes: The Best for Coagulation Testing? - LabRoots Clinical Dx Forum

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