摘要
目的:探讨肝素和EDTA抗凝血POCT血糖仪血糖(Glu)检测结果是否存在差异。方法:采集两种抗凝血,用6台POCT血糖仪(简称"仪器1～6")和全自动干化学仪(简称"干化学仪")分别检测血糖,以干化学仪检测值为"标准",将两种抗凝血POCT血糖仪检测结果与之比较,计算偏差,以体外诊断检验系统自测用血糖监测系统通用技术条件(简称"通用技术条件"GB/T19634-2005)为依据,Glu>4.2mmol/L,相对偏差≤20%结果为合格。Glu≤4.2mmol/L,绝对偏差<0.83mmol/L为合格,本次比对以每台仪器≥80%检测结果合格为该血糖仪合格判断标准。然后对每台POCT血糖仪肝素和EDTA抗凝血检测结果作相关分析。结果:Glu>4.2mmol/L时,仪器1～6肝素抗凝血与"标准"最小偏差0.5%,最大偏差28.6%。EDTA抗凝血与"标准"最小偏差0.2%,最大偏差26.8%。Glu≤4.2mmol/L时,各台仪器两种抗凝剂检测值与"标准"均小于0.83mmol/L。仪器1～6肝素抗凝静脉血(Y)和EDTA抗凝静脉血(X)相关系数r2>0.95(P<0.01)。结论:结果提示,肝素和EDTA抗凝血POCT血糖仪检测结果无明显差异。EDTA与肝素2种抗凝剂对血浆葡萄糖的检测结果无显著影响。
Objective：To evaluate the consistency of testing results of blood glucose （Glu） in heparin and EDTA anticoagulated blood specimens between 6 point-of-care testing （POCT） blood glucose meters and the VITROS 250 biochemical analyzer. Methods：The two kinds of anticoagulated blood samples were detected by 6 POCT blood glucose meters and the VITROS 250 biochemical analyzer,respectively. The detection results of POCT blood glucose meters in the two kinds of anticoagulated blood specimens were compared with those by VITROS 250 biochemical analyzer,which act as target value,then to calculate the relative bias. According to general specification in vitro diagnosetic test systems for blood glucose self-test monitoring system （GB/T19634-2005）,when the Glu4.2 mmol/L or Glu≤4.2 mmol/L,the results of relative deviation and absolute deviation were satisfactory and lower than 20% ,0.83 mmol/L,respectively. The detected results of heparin anticoagulated blood samples for each POCT glucose meter were analyzed to determine their correlation with EDTA anticoagulated blood. Results：When the values of glucose were over 4.2 mmol/L,the minimal and maximal deviation of the testing results from the POCT glucosemeters and the VITROS 250 biochemical analyzer was 0.5%,28.6%,respectively,in heparin anticoagulated blood samples. It was 0.2%,26.8%,respectively,in EDTA anticoagulated blood samples. When the values of glucose were less than 4.2 mmol/L,absolute deviation of the testing results from the POCT glucosemeters and the VITROS 250 biochemical analyzer was less than 0.83 mmol/L in two anticoagulated blood samples. The detected results of heparin and EDTA anticoagulated blood had a good correlation and the correlation coefficient was over 0.95 （P0.01）. Conclusion：The testing results of the POCT glucosemeters are not different significantly in heparin and EDTA anticoagulated blood samples as compared with the VITROS 250 biochemical analyzer.
出处
《中国医学装备》
2011年第7期29-33,共5页
China Medical Equipment
