摘要
目的 评价二级标准检测系统测定血小板结果的准确性与可比性,以确认新鲜血定值结果的准确和可靠程度.方法 参照美国CLSI文件EP9-A2,将二级标准检测系统与参考方法的血小板计数结果进行比对,评价40份静脉血标本检测结果的相关性和偏倚；将NCCL和日本参考实验室的二级标准检测系统的检测结果进行比对；用二级标准检测系统对36份正常新鲜血标本进行定值,将其作为校准物,用于常规实验室36台血细胞分析仪的校准.结果 二级标准检测系统与参考方法检测结果分布范围分别为（108 ～326）×109/L和（110～327）×109/L,具有良好的相关性,相关系数（r）为0.993,偏倚分布范围为-3.8％～3.4％.2009-2010年NCCL检测质控品的结果分布范围为（185 ～203）×109/L,日本参考实验室检测质控品的结果分布范围为（185～ 198）×109/L,比对数据的CV分别为2.0％～3.0％和2.6％ ～3.4％,比对数据的偏倚分布范围为-1.4％～3.7％；验证结果符合要求的20台血细胞分析仪的偏倚分布范围为-2.6％～2.1％,其余需要校准的16台血细胞分析仪校准前后的偏倚由3.4％ ～ 12.6％降至0％ ～2.8％.结论 参考实验室间的结果比对保证了血小板计数结果的准确性和可比性；二级标准检测系统定值的新鲜血作为校准物用于血细胞分析仪的校准是可行的.
Objective To evaluate the accuracy and comparability of secondary hematology analyzer for platelet enumeration in order to determine the accuracy and reliability of assigned value of fresh blood.Methods The results between secondary standard hematology analyzer and the reference method of platelet enumeration of 40 specimens were compared according to the document from CLSI EP9-A2.The correlation and bias were calculated.At the same time,the results of secondary standard hematology analyzer between our laboratory and Japan reference laboratory were compared.The fresh blood from normal people was prepared to be used as calibrator after assigned value by secondary standard hematology analyzer.And 36 hematology analyzers were performed correctness validation and calibrated by 36 fresh bloods.Results The results of 40 specimens by secondary standard hematology analyzer and the reference method were （ 108 -326） × 109/L and（ 110 -327 ） × 109/L respectively.Correlation coefficient between the secondary standard hematology analyzer and the reference method was 0.993.The bias between two methods was from -3.8%to 3.4%.The results of NCCL and Japan reference laboratory from 2009 to 2010 were（ 185 -203） × 109/L and （185 - 198） × 109/L The bias range between our laboratory and reference laboratory in Japan was from - 1.4% to 3.7%.The ranges of coefficient variations of two laboratories were from 2.0% to 3.0% and from 2.6% to 3.4%,respectively.The biases of 20 hematology analyzers were from - 2.6% to 2.1% and they passed the correctness validation.The biases of 16 hematology analyzers were decreased from 3.4% - 12.6%of pre-calibration to 0% - 2.8% of post-calibration.Conclusions The results of secondary standard hematology analyzer are assured to be accurate and comparable by the comparison of reference laboratories.It is feasible that fresh blood assigned value by secondary standard hematology analyzer can be used as calibrator for the hematology analyzer.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2011年第10期945-948,共4页
Chinese Journal of Laboratory Medicine
基金
国家自然科学基金资助项目（30972818）
关键词
参考标准
血小板计数
校准
可重复性
结果
Reference standards
Platelet count
Calibration
Reproducibility of results
