血细胞分析仪比对试验应用的评价

Evaluation on a comparative test of hematology analyzers

目的验证不同血细胞分析仪检测结果之间的可靠性和可比性,规范操作血细胞分析仪的比对试验。方法选择一台可溯源的血细胞分析仪作为参考比对仪器。在各仪器的精密度检测合格后,用新鲜高、中、低抗凝全血分别在各仪器上检测,收集白细胞、红细胞、血红蛋白、红细胞比容、血小板5个项目的数据,应用差异百分率方法将各仪器检测数据与参考仪器数据进行比对。结果各比对仪器携带污染率正常;检测指标的变异系数以及在不同血细胞分析仪上的总体变异系数均小于5%;各检测项目的差异百分率符合ICSH制定的标准;20例标本在不同血细胞分析仪上检测的各项指标经两两比较的q检验(Newman-Keuls法),各配伍组总体均数差异无统计学意义(P>0.05);连续7d测得的各项指标与参考样机之间的相关系数均大于0.97,其相对偏差在实验允许误差范围内。结论当同一实验室使用不同的血细胞分析仪时,应定期对仪器进行比对分析,发现问题及时校准,保证检测结果的准确性。

Objective To analyze the reliability and comparability of different hematology analyzers and standardize the operation of a comparative test.Methods We selected one analyzer which can be cast back to precision value as a standard comparative instrument.After precision of different analyzers were qualified,fresh high-,mid-and low-value anticoagulant blood were detected by these analyzers,then we compared results of WBC,RBC,HB,HCT and PLT with those of the standard analyzer by average variation percentage respectively.Results The carry-over rate of all contrast hematological analyzers were normal.Coefficient of the variation of the detective items and the total coefficient of variation of different hematological analyzers were all less than 5%.The test results of 20 blood samples detected by different hematological analyzers were analyzed by a q test which indicated that there were no statistical differences between blocks（P〉0.05）.The correlative coefficient was over 0.97 and the relative deviation was within the range of allowable error.Conclusion When there are different hematology analyzers in a laboratory,we should compare their results periodically to make calibration in time and guarantee accuracy of the results.