血细胞分析仪比对实验应用的评价探讨

Evaluation on comparative test of hematology analyzers

关键词:  血细胞分析仪  比对试验  可比性

Key words:  hematology analyzer  comparative test  comparability

摘要:

［目的］ 通过比对实验，探讨同一生产厂家不同型号的血细胞分析仪可比性。［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WBC、RBC、HB、HCT、PLT五个项目的数据，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］WBC分别为（%）0.43、0.67、4.29；RBC为（%）1.06、0.35、1.24；HBG为（%）0.6、2.91、0.79；HCT为（%）0.09、2.49、2.65；PLT为（%）3.1、1.42、2.67。所得结果均小于国际血液学标准化委员会（ICSH）和NCCLS的相关规定范围；符合1/2 CLIA88范围作标准，WBC±7.5%，RBC±3%，HB±3.5%，PLT±12.5%；证明了各仪器所测结果间测得数据具有可比性；在临床应用中可以相互替换使用。［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。

Abstract:

［Objective］To investigate comparability between different hematology analyzers of the same company through comparative tests.［Methods］Select 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 in these analyzers. Compare results of WBC, RBC, HB, HCT and PLT with those of the standard analyzer by average variation percentage respectively.［Results］WBC average variation percentages were(%) 0.43,0.67,4.29; RBC average variation percentages were(%) 1.06,0.35,1.24; HBG average variation percentages were(%)0.6,2.91,0.79;HCT average variation percentages were(%) 0.09,2.49,2.65; PLT average variation percentages were(%)3.1,1.42,2.67. The comparative results are all less than regulated range of ICSH and NCCLS. It proves that results of different analyzers have good comparability and can be replaced by each other in clinical application.［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.