新鲜血比对方法在血液分析仪室内质量控制中的应用

Application of comparison method in internal quality control of hematology analyzer by using fresh blood

目的利用新鲜血样本以比对方法对血液分析仪全血细胞计数进行室内质量控制。方法选择性能良好、规范化操作的血液分析仪为参比仪,用该仪器定值的健康人新鲜血校准比对血液分析仪(比对仪),进行为期3个月比对实验,建立比对仪比对参数WBC、RBC、HGB、HCT、PLT低、中、高值相对偏差的可接受范围。每工作日选取门诊患者比对参数低、中、高值至少2个水平新鲜血常规标本,将比对仪和参比仪检测结果进行比对,计算WBC、RBC、HGB、HCT、PLT相对偏差;以日期为横坐标,相对偏差为纵坐标,将可接受相对偏差范围设置为±2s,在实验室信息系统中建立新鲜血比对质控图,以制定的新鲜血比对质量控制规则对相对偏差进行判断、分析,对失控情况及时作相应处理,保证仪器正常运作。结果以建立的方法进行室内质量控制,2006年比对仪WBC、RBC、HGB、HCT、PLT低、中、高水平比对样本测定结果相对偏差的x±s(%)分别为:0.75±2.964、1.19±2.488、1.43±2.439;-0.39±1.327、-0.26±1.297、-0.35±1.095;-0.43±1.393、-0.17±1.139、0.24±1.166;-0.43±1.362、-0.36±1.381、-0.57±1.299;-0.93±4.330、0.04±4.118、-0.41±4.149。2006年该比对仪作为第二台仪器参加美国病理学家学会血细胞分析能力验证,WBC、RBC、HGB、HCT、PLT测定值与靶值的偏倚(%)范围分别为-0.5～5.1、-1.0～1.6、-1.7～1.4、-1.5～1.3、-4.5～7.4。结论该方法可方便、经济地对血液分析仪进行有效的质量控制。

Objective To investigate the comparison method on internal control of hematology analyzer by using fresh blood.Methods Selecting the hematology analyzer with good functions and standardized operation as the reference analyzer,using healthy people’s fresh blood with the values assigned by the reference analyzer to calibrate the compared hematology analyzer.Establishing the acceptable limits of relative deviation of WBC,RBC,HGB,HCT,PLT by comparative experiments among three months.Using fresh blood samples with low /medium/high levels from patients daily at least two levels,the results of compared analyzer is compared with reference analyzer’s,calculate the relative deviation of WBC,RBC,HGB,HCT,PLT,respectively.Establishing the internal quality control charts in Laboratory Information System,with date as x-axis,relative deviation as y-axis and the acceptable relative deviation limits is set to be ±2s,the judgment whether it is out of control is based on the fresh blood comparison control rule worked out in laboratory.Results The x±s(%)of relative deviation of WBC,RBC,HGB,HCT,PLT with high,medium,low levels for compared analyzer are 0.75±2.964,1.19±2.488,1.43±2.439;-0.39±1.327,-0.26±1.297,-0.35±1.095;-0.43±1.393,-0.17±1.139,0.24±1.166;-0.43±1.362,-0.36±1.381,-0.57±1.299;-0.93±4.330,0.04±4.118,-0.41±4.149,respectively,in 2006.As the second instrument,the compared analyzer has been involved in College of American Pathologists Proficiency testing with satisfactory result and the bias(%)of WBC,RBC,HGB,HCT,PLT are within-0.5～5.1,-1.0～1.6,-1.7～1.4,-1.5～1.0,-4.5～7.4,respectively,in 2006.Conclusion This method has effectively,conveniently,economically performed quality control on compared hematology analyzer.