CECertified POCT Vitamin D Test Kit
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GoldHealth Medical: Revolutionizing Vitamin D Testing with Precision and Speed
Product Overview
GoldHealth Medical introduces a cutting-edge Point-of-Care Testing (POCT) solution for vitamin D assessment. Designed exclusively for in vitro diagnostic use, this diagnostic kit ensures accurate and reliable results when used according to the provided instructions. Deviations from the protocol may compromise the reliability of the assay.
This diagnostic tool is a fluorescence immunochromatographic assay for the quantitative detection of 25-hydroxy Vitamin D (25-(OH)VD) in human serum or plasma. It serves as an essential auxiliary diagnostic reagent, primarily used to evaluate vitamin D levels. All positive results must be confirmed through alternative methodologies. This test is intended solely for use by healthcare professionals.
Why Choose Our Solution?
– Rapid Results: Obtain precise measurements of 25-(OH)VD within 15 minutes.
– Comprehensive Evaluation: 25-(OH)VD is the most reliable indicator of vitamin D status, reflecting both total levels and conversion efficiency.
– Ease of Use: Streamlined workflow ensures minimal training requirements while maximizing efficiency.
Scientific Background
Vitamin D, a vital nutrient and steroid hormone, exists primarily as Vitamin D2 and D3. These forms are metabolized into 25-hydroxy Vitamin D (25-(OH)VD), which is stable, abundant, and reflective of overall vitamin D levels. Monitoring 25-(OH)VD is critical for assessing vitamin D sufficiency and guiding clinical decisions.
How It Works
The test employs advanced immunochromatographic technology. The test region of the membrane is coated with BSA-conjugated 25-(OH)VD, while the control region features goat anti-rabbit IgG antibodies. Fluorescently labeled anti-25-(OH)VD antibodies and rabbit IgG are pre-coated on the marker pad. During testing, 25-(OH)VD in the sample binds to the fluorescent antibody, forming an immune complex. As the complex migrates across the membrane, the fluorescence signal inversely correlates with the concentration of 25-(OH)VD, enabling precise quantification.
Kit Components
– Test cards, individually foil-packed with desiccant
– A solution (25T)
– B solution (1)
– Package insert
Materials Required but Not Provided
– Sample collection containers
– Timer
Sample Collection and Storage Guidelines
– Acceptable samples: Serum, heparin anticoagulant plasma, or EDTA anticoagulant plasma
– Samples should be collected using standard techniques
– Storage: Refrigerate at 2-8°C for up to 7 days or freeze below -15°C for up to 6 months
– Avoid freeze-thaw cycles
Assay Procedure
1. Allow all reagents and samples to reach room temperature.
2. Power on the Portable Immune Analyzer and log in to access the detection interface.
3. Scan the identification code to confirm the test item.
4. Remove the test card from its foil pouch.
5. Insert the card into the analyzer’s slot, scan the QR code, and confirm the test item.
6. Add 30 μL of serum or plasma to Solution A and mix thoroughly.
7. Add 50 μL of Solution B to the mixture and mix well.
8. Incubate the mixture for 15 minutes.
9. Transfer 80 μL of the mixture to the sample well of the test card.
10. Initiate the test by clicking the “standard test” button. After 10 minutes, the analyzer will automatically detect the card and display the results. Record or print the findings as needed.
GoldHealth Medical: Empowering Healthcare Professionals
Our diagnostic kit is designed to meet the needs of hospitals, clinics, research institutions, and more. With its rapid, reliable, and user-friendly design, it sets a new standard for vitamin D testing. Trust GoldHealth Medical to deliver precision and innovation to your practice.
Common Shipping and Delivery Considerations
- Packaging:
Medical devices need secure packaging to avoid damage during transit, including shock-absorbing materials or custom foam inserts. - Compliance with Regulations:
Ensure compliance with local and international standards (e.g., FDA, CE) and shipping regulations like Good Distribution Practice (GDP). - Temperature Control:
Some devices require temperature-controlled shipping (e.g., refrigerated trucks or special packaging) to maintain product integrity. - Tracking and Documentation:
Shipments should be tracked with necessary documents like invoices, certificates, and import/export paperwork. - Lead Time:
Plan ahead for lead times, which can vary depending on the equipment size and delivery location. - Insurance: Due to the high value of medical equipment, consider insurance to protect against loss or damage during transit.
- Customs and Import Regulations: Account for customs procedures and tariffs when shipping internationally, ensuring proper documentation.
- Special Handling:
Fragile or hazardous medical devices may require special handling, with clear labeling to ensure proper care. - Delivery Method:
Choose the appropriate shipping method (air, sea, or ground) depending on the equipment’s size, value, and urgency. - Returns and Reverse Logistics:
Have a clear process in place for returns, repairs, and warranty claims if necessary.
Frequently Asked Questions
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Our mission and vision
At Gold Health Medical, our vision is to revolutionize healthcare by providing high-quality medical equipment that enhances patient care and improves healthcare efficiency. We are committed to being a trusted partner for medical professionals and institutions, ensuring they have access to the latest and most reliable medical technology.
Our goal is to bridge the gap between innovation and accessibility, making advanced healthcare solutions available to providers worldwide. Through excellence in service, integrity, and continuous improvement, we strive to empower healthcare professionals with the tools they need to deliver superior patient outcomes.
Together, we are shaping the future of medical care—one innovation at a time.
What Our Customers Say
At Gold Health Medical, we take pride in delivering high-quality medical equipment and exceptional customer service. Here’s what our satisfied clients have to say about their experience with us:
Company Name: GoldHealth Medical
Product Name: Vitamin D Home Rapid Test Cassettes
Product Overview:
Experience precision and reliability with GoldHealth Medical’s Vitamin D Home Rapid Test Cassettes. Designed for both professional and personal use, this diagnostic tool delivers accurate results within minutes, empowering healthcare providers and individuals to monitor Vitamin D levels effortlessly. Its user-friendly cassette and test strip format ensures ease of use without compromising accuracy.
Key Features:
- Accuracy: 99% precision for dependable results
- Response Time: Rapid detection in just 15 minutes
- Format: Convenient cassette and test strip design
- Temperature Range: Operates effectively between 2°C to 30°C
- Shelf Life: Stable for up to 2 years
Technical Specifications:
- Instrument Classification: Class III medical device
- Safety Standard Compliance: EN 149-2001+A1-2009
- Material: High-quality, durable plastic
- Power Source: Manual operation – no batteries or electricity required
Certifications and Quality Assurance:
- Quality Certification: CE certified for safety and performance
- Warranty: Backed by a 1-year warranty for peace of mind
After-Sales Support:
- Onsite Training: Comprehensive training provided to ensure proper usage
Packaging Details:
- Packaging Format: 25 tests per bag
- Supply Capacity: Up to 1,000,000 bags per month
GoldHealth Medical’s Vitamin D Home Rapid Test Cassettes are the ideal solution for hospitals, clinics, research labs, and home users seeking a reliable, efficient, and accurate diagnostic tool. Elevate your testing capabilities with a product designed to meet the highest standards of quality and performance.
