不同实验室间血细胞分析仪比对试验的应用评价

摘要

Objective:By comparing test to evaluate the accuracy results of four different laboratory blood cell analysis and consistency to investigate the standardized tests on the blood cell analyzer compartment. Methods:Take XE-2100 hematology analyzer traceable reference instrument, the 6 consecutive month with fresh anti-coagulated whole blood were compared to the test in 4 instruments four laboratories, collection of WBC, RBC, HB, HCT, PLT five project data, according to the United States clinical laboratory Amendment Act (CLIA, 88) evaluated documents the allowable error of 1/2.Results:The results of four laboratories of hematology analyzers 6 months five comparison of average relative deviation are in line with the 1/2CLIA criteria, 88 (WBC 1.52%、2.14%、3.25%;RBC 1.09%、0.65%、1.32%;HB 0.89%、2.08%、1.14%;HCT 0.25%、1.98%、2.36%;PLT 3.98%、6.54%、8.77%), the correlation coefficient γ >0.96; part of the instrument in 3 months after different degree beyond the acceptable range, after adjustment to eliminate the system errors.Conclusions:regular use of fresh whole blood analysis to do comparison among laboratories can discover the system error of instrument, through the adjustment and calibration laboratories can ensure accuracy and consistency of hematology analyzers.%目的：通过比对试验评价四家不同实验室血细胞分析结果的准确性和一致性，探讨血细胞分析仪室间比对试验的规范化。方法：以可溯源的XE-2100血细胞分析仪为参比仪器，连续6个月用新鲜抗凝全血在四家实验室的4台仪器上进行比对试验，收集WBC、RBC、HB、HCT、PLT五个项目数据，参照美国临床实验室修正法案（CLIA，88）文件规定的允许误差的1/2进行评估。结果：四家实验室血细胞分析仪6个月五个比对项目的平均值相对偏差均符合1/2CLIA，88的判断标准（WBC为1.52%、2.14%、3.25%；RBC为1.09%、0.65%、1.32%；HB为0.89%、2.08%、1.14%；HCT为0.25%、1.98%、2.36%；PLT为3.98%、6.54%、8.77%），相关系数γ均>0.96；部分仪器在3个月后有不同程度超出可接受范围，进行校准后系统误差得以消除。结论：定期使用新鲜全血在不同实验室间做比对分析，能及时发现仪器的系统误差，通过调整与校准可确保不同实验室间血细胞分析的准确性和一致性。