不同血细胞分析仪多水平比对试验方案的建立和应用

Establishment of comparative test program for verification test with different blood cell analyzers

  • 摘要: 目的 对不同型号血细胞分析仪进行红细胞、白细胞、血红蛋白、血小板等指标的多水平比对试验,以保证多台仪器测定结果的准确性和可比性。方法 每月进行1次仪器比对:选择1台参加全国质量评价合格的血细胞分析仪作为参考比对仪器,采用五个水平的新鲜抗凝血进行检测,每个水平检测10次,取10次的均值做为靶值,同时在几台血细胞分析仪上检测,参考美国临床实验室改进修正案(CLIA′88)能力比对检验质量要求及NCCLS制定的标准,判断测试仪器与参比仪器的相对偏差是否符合标准。结果 通过仪器比对,反映了测定仪器与参考比对仪器测定结果的一致性,对个别超出判断标准的仪器进行校准。结论 在保证每台仪器的重复性和稳定性均良好的前提下定期对仪器进行比对分析,可有效保证检验结果的准确性。

     

    Abstract: Objective To evaluate the accuracy and comparability of test parameters such as WBC,RBC,PLT,HCT,and MCV,detected with 10 different blood cell analyzers. Methods Verification test was performed each month to evaluate the accuracy and comparability of test parameters such as WBC,RBC,PLT,HCT,and MCV detected with 10 different blood cell analyzers.A blood cell analyzer was selected as the reference analyzer used in verification test.Fresh anti-coagulation blood was used to detect the test parameters at 5 levels and 10 tests were performed at each level.The average value of 10 tests was taken as the target value detected with several blood cell analyzers.Deviation error of the assessed and reference analyzers was calculated and judged whether it meets the revised criteria of US Clinical Laboratories(CLIA 88) and the standards established by NCCLS. Results The verification test showed that the parameters detected with blood cell analyzers were consistent with those detected with other devices.However,certain devices should be calibrated if their deviation error was out of the standard range. Conclusion Regular verification test can effectively control the accuracy of detected parameters when the device used has a good reproducibility and repeatability.

     

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