Sample density separation liquid
High clarity, IVD-grade
One-click copy of information
Instruction manual- Product Description
- Composition
- Precautions
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[Product Name] Sample density separation solution
[Product Item Number] X001
[Packaging Specifications] 250 mL/bottle
[Intended Use] Sample density separation solutions utilize density‑based separation to isolate different components within a sample, facilitating subsequent analytical procedures.
[Principle of Assay]
Peripheral blood contains mononuclear cells, including lymphocytes and monocytes, which differ from other cells in size, morphology, and density. Red blood cells and white blood cells have relatively high densities, around 1.090 g/mL, whereas lymphocytes and monocytes exhibit densities of 1.075–1.090 g/mL, and platelets have a density of 1.030–1.035 g/mL. To address this, our company mixes hydroxyethyl starch with meglumine diatrizoate in specific proportions, adjusts the pH and osmotic pressure, and, after clarification and sterile filtration, produces an isotonic solution (the separation medium). This solution is then subjected to density‑gradient centrifugation, allowing cells of different densities to distribute according to their respective gradients, thereby enabling the separation of various blood cell types.
[Storage Conditions and Shelf Life]
Store at room temperature, protected from light; shelf life: 2 years. Transport at room temperature.
[Applicable Instruments]
15 cm radius horizontal rotor centrifuge.
[Sample Requirements]
This separation solution requires fresh anticoagulated blood; blood collection must be performed under aseptic conditions, and freezing or refrigeration should be avoided during storage, processing, and transport.
[Instructions for Use]
Collect 1 mL of fresh anticoagulated blood, mix it with an equal volume of sterile saline for injection, and carefully layer the mixture on top of 1 mL of cell separation solution. Centrifuge at 600–800 × g (using a horizontal rotor with a radius of 15 cm) for 20–30 minutes. At this point, the centrifuge tube will contain four distinct cell layers, from top to bottom:
1) The first layer is the plasma layer (containing platelets);
2) The second layer consists of a ring-like, milky-white lymphocyte layer (mononuclear cell layer);
3) The third layer is a transparent separation liquid layer;
4) The fourth layer is the erythrocyte layer (containing a large number of granulocytes).
Collect the cells and transfer them into a test tube containing 45 mL of sterile saline for injection. After thorough mixing, centrifuge at 500g for 20 minutes to pellet the cells, then wash the pellet twice with fresh saline to obtain the desired cell preparation.
Separation Legend
[Positive Judgment Value or Reference Interval]
Not a testing reagent; not applicable.
[Interpretation of Test Results]
Not a testing reagent; not applicable.
[Limitations of the Analytical Method]
This test requires that, under normal atmospheric pressure, the sample, the separation solution, and the ambient temperature be maintained at 20°C ± 2°C. The separation solution exhibits a higher density at low temperatures and a lower density at high temperatures.
[Product Performance Specifications]
1. Appearance and Physical Properties
1.1 The liquid in the product reagent bottle is colorless and transparent, with no leakage on the exterior of the bottle.
1.2 Chinese-language packaging labels shall be clear, accurate, and free from wear.
2. pH
Transfer 3 mL of the sample density separation solution into a 15-mL centrifuge tube, and use a pH meter to determine that the pH of the solution should be between 7.2 and 7.4.
3. Cell separation recovery rate
After centrifuging the red and white blood cells on a sample density gradient, they are clearly separated. Pipette 1 mL of the separation medium into a 15-mL centrifuge tube; after counting the labeled white blood cells (typically around 30), resuspend them in 1 mL of XRC buffer and add this suspension to 50 mL of blood, mixing thoroughly. Then, carefully overlay the entire cell suspension onto 1 mL of the separation medium and centrifuge at 550 × g for 5 minutes. Carefully transfer the entire supernatant from the bottom brown‑red layer into a 15-mL centrifuge tube, mix well, and centrifuge again at 1,050 × g for 3 minutes. Discard the supernatant, resuspend the pellet in 100 µL of buffer, and count the cells under a fluorescence microscope; the recovery rate should be ≥80% (e.g., if 30 white blood cells were added, at least 24 should be recovered).
4. Repeatability
The coefficient of variation (CV) shall not exceed 5%.
5. Stability
Products stored in a 4°C refrigerator for more than one month and those stored in a 37°C constant‑temperature water bath for 7 days (accelerated testing) shall comply with the requirements specified in items 1 and 3 above.
[Explanation of the Logo]
[References]
1. Zheng Dexian, Wu Kefu, Chu Jianxin. Modern Methods and Techniques in Experimental Hematology, Joint Publishing House of Beijing Medical University and Peking Union Medical College, 1999.
2. E Zheng, Tissue Culture, Beijing Publishing House, 1995
3. Zhu Liping, Chen Xueqing, Common Experimental Methods in Immunology, People’s Military Medical Press, 2000
[Basic Information]
Filing Entity/Manufacturing Enterprise: Albatross Biotechnology (Guangzhou) Co., Ltd.
Address: Room 219, self‑numbered unit, Nos. 689–709 (odd numbers), Jiangnan Avenue South, Haizhu District, Guangzhou (office use only) Contact Information:
400-090-1923
After-sales Service Provider Name: Albatross Biotechnology (Guangzhou) Co., Ltd.
Contact Information: 400-090-1923
Production Address: Room 321–332, Building G5, No. 39 Ruihe Road, Huangpu District, Guangzhou City
[Medical Device Filing Certificate Number/Product Technical Requirements Number: Yue-Sui Med Device Filing 20220455] [Medical Device Manufacturing Filing Certificate Number: Yue-Sui Drug Administration Med Device Manufacturing Filing 20220072]
[Date of Approval and Revision of the Instruction Manual: January 1, 2022]
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[Main Ingredients]
The main components are hydroxyethyl starch and meglumine diatrizoate.
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[Precautions]
1. After opening, store at room temperature to prevent microbial contamination.
2. After removing the cell separation solution from the refrigerator, do not use it immediately; allow it to reach room temperature, then shake well before use.
3. Throughout the entire isolation process, the temperature should be maintained at 20°C ± 2°C and carried out under sterile conditions to prevent microbial contamination; otherwise, the quality of the isolation may be compromised.
4. If the product comes into contact with skin during use, rinse thoroughly with water. If discomfort persists, seek medical attention promptly.
5. Waste generated during the use of this product shall be disposed of in accordance with laboratory regulations, together with blood samples, for unified destruction.
6. The use of expired products is strictly prohibited.
7. This product is intended for in vitro diagnostic use only.
Keywords
GOONIE
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Goonie Biotechnology (Guangzhou) Co., Ltd.
Room 321–332, Building G5, No. 39 Ruihe Road, Huangpu District, Guangzhou
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