GoldHealth Medical – 25-Hydroxy Vitamin D Diagnostic Solution

Product Overview

GoldHealth Medical presents a cutting-edge diagnostic solution for the rapid and precise detection of 25-hydroxy Vitamin D (25-(OH)VD) levels. Designed exclusively for in vitro diagnostic use, this fluorescence immunochromatographic assay delivers reliable results within 15 minutes, empowering healthcare professionals with actionable insights.

Key Features and Benefits

• Quantitative Precision: Accurately measures 25-(OH)VD in human serum or plasma, offering a comprehensive evaluation of vitamin D levels.
• Rapid Results: Delivers results in just 15 minutes, enabling swift clinical decision-making.
• Stable and Reliable: Detects the most stable form of vitamin D, ensuring consistent and dependable readings.
• User-Friendly Design: Simplified workflow with intuitive operation, minimizing the potential for errors.
• Auxiliary Diagnosis: Serves as an essential tool for healthcare professionals, with all positive results requiring confirmation via alternative methodologies.

Scientific Background

Vitamin D, a vital nutrient and steroid hormone, exists primarily as VD2 and VD3. These forms are metabolized into 25-hydroxy Vitamin D (25-(OH)VD), which is renowned for its stability and high concentration in the body. As the optimal marker for assessing vitamin D status, 25-(OH)VD reflects both the total amount of vitamin D and its metabolic conversion efficiency.

Principle of Operation

The diagnostic kit employs advanced immunochromatographic technology. The test device membrane is coated with BSA-conjugated 25-(OH)VD in the test region and goat anti-rabbit IgG antibody in the control region. 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 fluorescently labeled antibodies, forming an immune complex. This complex flows through the membrane, where free fluorescent markers bind to immobilized 25-(OH)VD. The fluorescence signal intensity inversely correlates with the concentration of 25-(OH)VD, enabling precise quantification.

Components Provided

• Test cards individually foil pouched with desiccant
• A solution (25T)
• B solution (1)
• Package insert

Required Materials (Not Provided)

• Sample collection container
• Timer

Sample Collection and Storage Guidelines

• Acceptable samples include serum, heparin anticoagulant plasma, or EDTA anticoagulant plasma.
• Samples should be collected using standard techniques. Serum or plasma can be refrigerated at 2-8°C for up to 7 days or cryopreserved below -15°C for up to 6 months.
• Avoid freeze-thaw cycles for all samples.

Assay Procedure

1. Allow all reagents and samples to reach room temperature.
2. Power on the portable immune analyzer and log in using the provided credentials.
3. Scan the identification code to confirm the test item.
4. Remove the test card from its foil pouch.
5. Insert the test card into the designated slot and scan the QR code to 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. Let the mixture stand for 15 minutes.
9. Add 80 μL of the mixture to the sample well of the test card.
10. Click the “standard test” button. After 10 minutes, the analyzer will automatically detect the test card, displaying the results on the screen. Record or print the results as needed.

Why Choose GoldHealth Medical?

GoldHealth Medical is committed to delivering innovative and reliable diagnostic solutions that meet the highest standards of accuracy and efficiency. Our products are designed to enhance patient care and streamline laboratory workflows, making them indispensable tools for healthcare professionals worldwide.