医疗器械血液学检测中人血与兔血介质的比较研究

Comparative study of human and rabbit blood mediators in hematological testing by medical devices

目的:对比兔血和人血2种血液的全血计数试验结果,探讨以兔血替代人血进行医疗器械血液学检测的可行性。方法:参考GB/T 16886.4—2022《医疗器械生物学评价第4部分:与血液相互作用试验选择》和ASTM F2888-13 Standard test method for platelet leukocyte count—an in-vitro measure for hemocompatibility assessment of cardiovascular materials,选择高密度聚乙烯、黑橡胶、玻璃珠、活性炭、天然橡胶、丁腈橡胶、高硼硅纤维滤纸、一次性使用真空瓶、一次性介入导管鞘套件、一次性使用输血器、血液透析器、体外循环血路12种医疗器械或材料,在同一试验条件下,分别以兔血和人血作为浸提介质,采用全自动血细胞分析仪测定WBC计数值和RBC计数值。结果:活性炭的WBC计数值和RBC计数值与空白对照相比的百分数均小于50%,其他医疗器械或材料的WBC计数值和RBC计数值与空白对照相比的百分数均大于50%。兔全血和人全血的全血细胞计数试验结果具有一致性。结论:在人血获取困难时,兔血可作为一种理想的血液来源应用于医疗器械的血液学检测。

Objective To investigate the feasibility of replacing human blood with rabbit blood for medical device hematology testing by comparing the two types of blood when used for complete blood count.Methods Rabbit blood and human blood were used as leaching media respectively to determine WBC and RBC values by a fully automated cell counter and the same test conditions,with references to GB/T 16886.4—2022 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood and ASTM F2888-13 Standard test method for platelet leukocyte count—an in-vitro measure for hemocompatibility assessment of cardiovascular materials.There were 12 kinds of medical devices or materials involved in the test,including high-density polyethylene,black rubber,glass bead,activated charcoal,natural rubber,nitrile rubber,high borosilicate fiber paper,disposable vacuum bottle,disposable interventional catheter sheath introducer kit,disposable transfusion set,hemodialyzer and extracorporeal circulatory blood circuit.Results The percentages of WBC values and RBC values for activated charcoal compared to the blank control were both lower than 50%,while those for the remained devices or materials were all higher than 50%.Rabbit blood and human blood had high consistency when used for complete blood count.Conclusion Rabbit blood can be used as an ideal blood source for hematological testing by medical devices when the source of human blood is insufficient.