Comparative study of human and rabbit blood mediators in hematological testing by medical devices
10.19745/j.1003-8868.2024172
- VernacularTitle:医疗器械血液学检测中人血与兔血介质的比较研究
- Author:
Xiao-Hui YE
1
;
Lei ZHANG
;
Ya-Bing ZHANG
;
Zhou ZHOU
Author Information
1. 安徽省食品药品检验研究院,合肥 230051
- Keywords:
hematological testing;
complete blood count;
human blood;
rabbit blood;
medical device;
blood compatibility
- From:
Chinese Medical Equipment Journal
2024;45(9):46-49
- CountryChina
- Language:Chinese
-
Abstract:
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.[Chinese Medical Equipment Journal,2024,45(9):46-49]
