本品为水剂型血液促凝剂，以纯化水为溶剂，搭配多种有效促凝成分，专为快速凝血、高效分离血清设计，适用于医用采血管制备及临床检验。
本品主要成分为促凝粉、超纯水、硅油等，各成分比例科学配比，确保促凝效果稳定，且不干扰临床检测。
本品为白色浑浊液体（水剂特性），静置后会出现沉淀，摇匀后呈均匀悬浊液；具有快速加速血液凝固的作用，对临床生化项目检测无任何影响，且水剂成分温和，无需烘干，无残留隐患。
适用范围
可用于制备真空采血管及注射式采血管，广泛应用于临床医学检验工作中。化验人员可在同一器皿中，完成血样采集、快速分离血清及样品传递等操作，简化检验流程，提高工作效率。
促凝原理
通过激活血浆及血小板中的部分凝血因子，促进凝血活酶和纤维蛋白凝块的生成，加速血球凝块收缩，从而达到快速分离血清的目的；其中纯化水可辅助分散促凝成分，增强促凝效果的均匀性，且对血液成分无任何刺激。
促凝能力
在25℃环境下，取15-20µl本品（水剂），可使5mL血样快速凝固；血液初始凝固后，静置30分钟左右即可上机离心（离心力：1200-1500g，离心时间：8-10分钟），顺利分离出血清。离心后血块收缩良好，血清析出量大，分离状态佳，无杂质残留，不干扰血液标本检测结果。当环境温度低于20℃时，可适当延长采血后静置时间，确保促凝充分，以达到最佳血清分离效果。
用法与用量
添加方式：采用机器喷雾法加入采血管，添加过程中须不断搅拌，保持悬浊液均匀，确保各有效成分添加量一致，避免因水剂分层影响促凝效果。
搅拌方式：可采用机械搅拌、电磁搅拌、气动搅拌等方式维持悬浊液均匀，搅拌速度根据实际设备及操作场景调整，以无明显沉淀、悬浊均匀为准。
烘干处理：本品为水剂，添加完成后无需进行烘干处理（区别于醇剂促凝剂），直接进行后续采血管制备即可。
辐照灭菌：如需进行辐照灭菌，建议辐照剂量控制在8-25kGy，灭菌后需检查产品性状，确保无异常。
用量标准：一般情况下，15-20µl本品可快速促凝5mL血样，用量误差范围控制在±10%。具体推荐用量如下表所示：
血样体积
| 建议添加剂量
|
3-4 mL
| 15 μL
|
5-7 mL
| 20 μL
|
8-15 mL
| 30 μL |
注意事项
- 若血液凝血不充分，会导致血球及纤维蛋白丝挂壁，甚至出现轻度溶血；部分患者血液若一次凝血不完全，可能出现凝血过程中止、纤维蛋白析出，或离心后无血清分离等情况，需及时检查操作流程及用量。
- 若凝血时间少于15分钟即上机离心，可能导致纤维蛋白丝二次析出，漂浮在血清中，极易造成检测探针堵塞，影响检验进度。
- 本品为水剂，具有亲水性，储存及使用时需密封，避免水分流失或外界杂质混入，导致成分比例失衡，影响促凝效果；避免与油性物质接触，防止污染。
- 添加过程中若出现悬浊液分层严重，需重新充分搅拌后再使用，确保促凝成分均匀分布。
- 密封保存，放置于阴凉干燥处，环境温度不得超过35℃；因水剂特性，低温（0-10℃）储存效果更佳，可有效延缓成分变质，保持促凝性能稳定；避免阳光直射及潮湿环境，防止霉变。
- 自生产之日起，有效期为三年；逾期不得使用，若发现产品出现浑浊异常、异味、霉变或沉淀无法摇匀，需立即丢弃。
This product is a water-based blood coagulant, using purified water as a solvent, combined with a variety of effective coagulation-promoting components. It is specifically designed for rapid blood clotting and efficient serum separation, suitable for the preparation of medical blood collection tubes and clinical testing.
Ingredients
This product mainly consists of coagulant powder, ultrapure water, silicone oil and other ingredients. The proportions of each component are scientifically formulated to ensure stable coagulation-promoting effects without interfering with clinical test results.
Properties
This product is a white turbid liquid (characteristic of water-based formulations). Sedimentation occurs upon standing, but it forms a uniform suspension after shaking. It rapidly accelerates blood coagulation without affecting clinical biochemical test items. The water-based components are mild, require no drying, and pose no residue risk.
Scope of Application
It can be used for preparing vacuum blood collection tubes and syringe-based blood collection tubes, widely applied in clinical medical testing work. Laboratory personnel can complete blood sample collection, rapid serum separation, and sample transfer in the same vessel, simplifying the testing process and improving work efficiency.
Coagulation Principle
By activating certain coagulation factors in plasma and platelets, it promotes the generation of thromboplastin and fibrin clots, accelerating blood clot contraction to achieve rapid serum separation. The purified water aids in dispersing the coagulation components, enhancing the uniformity of the coagulation effect, and causes no irritation to blood components.
Coagulation Capacity
At 25°C, adding 15-20µl of this product (water-based) can rapidly coagulate 5mL of blood. After initial blood clotting, allow it to stand for about 30 minutes before centrifugation (centrifugal force: 1200-1500g, centrifugation time: 8-10 minutes) for smooth serum separation. After centrifugation, the clot contracts well, yielding a large amount of serum with excellent separation, free from impurities, and does not interfere with blood sample test results. When the ambient temperature is below 20°C, the standing time after blood collection can be appropriately extended to ensure full coagulation and achieve the best serum separation effect.
Usage and Dosage
- Addition Method: Add to blood collection tubes using machine spraying. Continuous stirring is required during the addition process to maintain the uniformity of the suspension, ensuring consistent addition of effective components and avoiding stratification that may affect the coagulation effect.
- Stirring Method: Mechanical stirring, electromagnetic stirring, or pneumatic stirring can be used to maintain the uniformity of the suspension. The stirring speed should be adjusted according to the actual equipment and operation scenario to ensure no significant sedimentation and uniform suspension.
- Drying Treatment: This product is water-based. No drying treatment is required after addition (different from alcohol-based coagulants). Subsequent preparation of blood collection tubes can proceed directly.
- Irradiation Sterilization: If irradiation sterilization is required, the recommended dose is 8-25kGy. After sterilization, check the product properties to ensure no abnormalities.
- Dosage Standard: Generally, 15-20µl of this product can rapidly coagulate 5mL of blood, with a dosage error range controlled within ±10%. The recommended dosage is as follows:
Blood Sample Volume
| Recommended Dosage
|
3-4 mL
| 15 μL
|
5-7 mL
| 20 μL
|
8-15 mL
| 30 μL |
Precautions
- If blood coagulation is insufficient, it may cause blood cells and fibrin strands to adhere to the tube wall, or even mild hemolysis. If blood coagulation is incomplete in some patients, it may result in the cessation of coagulation, fibrin precipitation, or no serum separation after centrifugation. The operation process and dosage should be checked promptly.
- If centrifugation is performed less than 15 minutes after coagulation, secondary precipitation of fibrin strands may occur, floating in the serum and potentially blocking detection probes, affecting testing progress.
- This product is water-based and hydrophilic. During storage and use, ensure sealing to avoid moisture loss or contamination by foreign impurities, which may disrupt component ratios and affect the coagulation effect. Avoid contact with oily substances to prevent contamination.
- If severe stratification of the suspension occurs during addition, stir thoroughly before use to ensure uniform distribution of coagulation components.
- Store sealed in a cool, dry place, with the ambient temperature not exceeding 35°C. Due to its water-based nature, low-temperature storage (0-10°C) is more effective in delaying component deterioration and maintaining stable coagulation performance. Avoid direct sunlight and humid environments to prevent mold growth.
- The shelf life is three years from the production date. Do not use beyond the expiration date. If abnormal turbidity, odor, mold, or sedimentation that cannot be redispersed by shaking is observed, discard immediately.
ZJ26F0434461
危险品化学品经营许可证（带存储）