Standardization of incubation conditions for hemolysis testing of biomaterials
Standardization of incubation conditions for hemolysis testing of biomaterials
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DOI：
10.1016/j.msec.2009.01.002
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发表时间：
2009-06-01
期刊：
影响因子：
--
通讯作者：
van Oeveren, Willem
中科院分区：
文献类型：
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作者：
Henkelman, Sandra;Rakhorst, Gerhard;van Oeveren, Willem
溶血试验是确定生物材料血液相容性的最常用方法。然而，由于对所用红细胞的质量和试验的实验条件进行的比较研究不足，因此对溶血试验的程序没有达成共识。在这项研究中，我们确定了一些孵育变量对溶血试验的灵敏度和重现性的影响，使用阳性和阴性反应的生物材料，并将这些结果与根据美国材料与试验协会（ASTM）标准获得的结果进行了比较。ASTM标准方法建议使用静态孵育3 h的高度稀释兔血进行溶血试验。在这项研究中，我们发现在37 ℃下将生物材料样品在稍微稀释的人血中或用洗涤的红细胞孵育24小时是最敏感的溶血试验。此外，在溶血试验中使用冻存人RBC似乎是新鲜RBC的良好替代品，因为冻存人RBC和新鲜人RBC在溶血试验中得到相似的结果。根据ASTM方法，通过将稀释的家兔红细胞暴露于生物材料或通过将生理盐水中的生物材料浸提液暴露于洗涤的人红细胞进行溶血试验，得出不同的结果，似乎不代表临床应用。(C)2009 Elsevier B.V.保留所有权利。
Hemolysis testing is the most common method to determine the hemocompatibility properties of biomaterials. There is however no consensus on the procedures of hemolysis testing due to insufficient comparative studies on the quality of the red blood cells used and the experimental conditions of testing. In this study we determined the effects of a number of incubation variables on the sensitivity and reproducibility of the hemolysis test using positively as well as negatively responding biomaterials and compared these results to those obtained according to the American Society for Testing and Materials (ASTM) standard. The ASTM standard method recommends hemolysis testing with highly diluted rabbit blood that is static incubated for 3 h. in this study we found that 24 h incubation of a biomaterial sample at 37 degrees C in slightly diluted human blood or with washed red blood cells was the most sensitive hemolysis test. Moreover usage of cryopreserved human RBC in the hemolysis test seemed to be a good alternative for fresh RBC since cryopreserved and fresh human RBC gave similar results in the hemolysis test. Hemolysis testing by exposing diluted rabbit erythrocytes to biomaterials as according to the ASTM method or by exposing biomaterials extract in saline to washed human red blood cells gave a different outcome and appeared not to be representative for clinical applications. (C) 2009 Elsevier B.V. All rights reserved.