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常规运动生化血液分析仪辅助校准方法的建立 被引量:1

The Building of an Aided Calibration Method for Routine Sports Biochemistry Blood Analyzers
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摘要 目的:使用运动员定值新鲜血建立常规血细胞分析仪和血生化分析仪的辅助校准方法。方法:根据比较实验的不同,总计采集213例(男155,女58)健将级及以上级别男、女运动员静脉血,取抗凝新鲜全血和混合血清。1)采血2h内以参加全国室间质评工作的DIFF2血细胞分析仪作为参考仪器,给运动员抗凝新鲜全血定值,用新鲜抗凝全血辅助校准GEN.S血细胞分析仪,并通过重复性检验、偏差检验和离群值检验与参考仪器比对WBC、RBC、HGB、HCT、PLT等5个血细胞参数;2)取血4h内以参加全国室间质评工作的7020生化分析仪作为参比仪器,把7020生化分析仪校准品的量值传递给1份混合运动员血清(由10份运动员新鲜血清等量混合而成),用新鲜混合血清辅助校准MD-100生化分析仪,并通过重复性检验、偏差检验和线性范围检验与参比仪器比较血清BUN、CK参数。结果:1)使用定值的新鲜抗凝全血辅助校准GEN.S血细胞分析仪后,重复性比对实验的5个血细胞参数的CV%值分别为1.4、0.6、0.4、0.6、2.3,符合测试精密度范围要求;偏差比对实验的5个血细胞参数的偏倚值(靶值±%)分别为-0.4、-0.5、1.8、-0.7、-4.1(男)和1.3、-0.8、1.5、-0.8、-4.2(女),远小于血细胞分析仪的最大允许误差范围;离群值比对实验显示,5个血细胞参数的异常高值离群值和异常低值离群值与参考仪器相比,没有出现显著差异(P>0.01)和偏离正态分布;2)使用定值的新鲜混合血清辅助校准MD-100血生化分析仪后,重复性比对实验的血清BUN、CK参数的CV%值分别为0.92、1.22,符合测试精密度范围要求;偏差比对实验的血清BUN参数的偏倚值(靶值±%)为0.2,血清CK参数的偏倚值(靶值±%)为0.9(男)、3.5(女),远小于血生化分析仪的最大允许误差范围;线性范围比对实验显示,与参考仪器比较,血清CK高值的非线性拐点在1 000 U/L附近。结论:1)使用控制时间的定值新鲜抗凝全血是建立运动生化常规血细胞分析仪辅助校准的可靠方法;2)使用控制时间的运动员新鲜混合血清是建立常规血生化分析仪辅助校准的可靠方法。建议:1)在GEN.S辅助校准后,对高水平运动员血细胞参数离群值的甄别还需扩大检测范围,并结合个体运动训练背景进行综合判断;2)对MD-100辅助校准后,对高水平运动员大于1 000U/L的血清CK高值的检测可以采用样本倍比稀释使数值回落在线性范围内的方法。 Objeetive:To build an aided calibration method for routine hematology analyzers and biochemistry analyzers by fresh blood specimens from athletes. Methods: 1) Sample of fresh whole blood from athlete was measured in 2 hours by DIFF2 hematology analyzer, an reference instrument participating the EQA program, then used to calibrate GEN. S hematology analyzer. The RN2, HGB, HCT, MCV and PLT counting of 155 male athletes and 58 female athletes were compared between the two hematology analyzers on repeatability test, bias test and outlier test. 2) A pooled serum from balanced mix of ten athletes fresh serum was measured in 4 hours by 7020 biochemistry analyzer, an reference instrument participating the EQA program, then used to calibrate MD-100 biochemistry analyzer. The serum level of BUN & CK of 100 male athletes and 26 female athletes were compared between the two biochemistry analyz- ers on repeatability test, bias test and linearity range test. Results: 1 ) After the aided calibration for DIFF2 hematology analyzer, the repeatability test showed that the coefficients of variation (CV)% of five hematological parameters were 1.4,0. 6,0. 4,0.6 and 2.3, beyond the degree of precision. The bias test showed that the bias value of five hematological parameters were respectively 0.4 minus, 0. 5, i. 8,0. 7 minus and 4. 1 minus in male group and 1.3,0. 8, 1. 5,0.8 minus, 4. 2 minus in female group, lower than the maximum permissible error. The outtier test showed that there was no significam difference in abnormally low or high value of five hematological parameters between the two hematology analyzers. 2) After the aided cali- bration for MD-100 biochemistry analyzer, the repeatability test showed that the CV~ o{ the serum level of BUN g,. CK were 0. 92 and 1.22,beyond the degree of precision. The bias test showed that the bias value of the serum level of BUN was 0.2, and that of the serum level of CK was respectively 0. 9 in male group and 3.5 in female group, lower than the maximum per- missible error. The linearity range test showed that inflection point of the serum level of CK was 1000U/L. Conclusion: 1) Application of athletes fresh whole blood for aided calibration of hematology analyzers is a reliable method. 2) Application of athletes fresh pooled .serum for aided calibration of biochemistry analyzers is a reliable method. It is proposed that the calibration method for hematology analyzers may be more helpful for the detecting athlete outliers in consideration of individual training background and that the calibration method for biochemistry analyzers can be more feasible to test the serum level of CK from athletes with sample dilution.
出处 《中国体育科技》 CSSCI 北大核心 2016年第5期136-144,F0003,共10页 China Sport Science and Technology
基金 国家体育总局体育科学研究所基本科研业务费项目(基本13-27)
关键词 运动生化 血液分析仪 校准方法 sports biochemistry blood analyzer calibration method
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