体育类生化室全自动生化分析仪检测项目性能评价和比对试验研究

Performance evaluation of testing items and comparative study of different fully automatic biochemical analyzer in sports biochemistry laboratory

目的对新购入的Dimension EXL200全自动生化分析仪进行性能评价和比对试验,以保证检测结果的准确性、可比性及延续性。方法以实验室常用检测指标:肌酸激酶(CK)、尿素(Urea)、尿酸(UA)、血糖(GLU)、总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白(HDL)和低密度脂蛋白(LDL)为例进行考察。参照美国临床和实验室标准化协会(CLSI)EP15-A3、CLSI EP6、美国临床实验室标准化委员会(NCCLS)C28-A2、NCCLS EP15-A2文件和中国合格评定国家认可委员会(CNAS)CNAS-GL037:2019,CNAS-CL38文件,使用原装进口定标液和试剂,伯乐质控品,从精密度、正确度、线性范围、临床可报告范围等角度对8个项目进行性能评价,以新鲜采集的211例血液样本分别在两台全自动生化分析仪上进行检测比对试验。结果Dimension EXL200全自动生化分析仪检测8个项目的精密度和正确度验证均合格;8个项目在分析测量范围内均表现出良好的线性关系(R2>0.95,a在0.97~1.03范围内);最大稀释倍数验证回收率在可接受范围内,临床可报告范围为分析测量范围的上限乘以最大的可稀释倍数;比对试验中211例新鲜血液样本8个项目在两台仪器上测得数据进行回归分析结果显示,所有检测项目相关系数r>0.9,相对偏倚小于实验室允许的偏倚或相对偏倚验证值,说明两台仪器可比性良好,检测结果一致性程度高,比对试验通过。结论Dimension EXL200全自动生化分析仪8个检测项目的精密度、正确度、线性范围和临床可报告范围性能评价均通过,保证了检测结果的准确性和可靠性;比对试验说明Dimension EXL200全自动生化分析仪的数据与原有的全自动生化分析仪检测结果具有一致性,为体育类生化实验室数据的延续性分析提供了保障。

Objective To ensure the accuracy,comparability and continuity of the test results,the author perform the performance evaluation of the newly purchased Dimension EXL200 automatic biochemical analyzer and conduct comparison tests.Methods Common indicators:creatine kinase(CK),urea(Urea),uric acid(UA),blood sugar(GLU),total cholesterol(TC),triglycerides(TG),high-density lipoprotein(HDL)and Take low-density lipoprotein(LDL)were examined as an examples.In accordance with the American Society of Clinical and Laboratory Standards Institute(CLSI)EP15-A3,CLSI EP6,National Committee for Clinical Laboratory Standards(NCCLS)C28-A2,NCCLS EP15-A2,China National Accreditation Service for conformity assessment(CNAS)CNAS-GL037:2019 and CNAS-CL38 document requirements,using the original imported calibration solution and reagents,and Bo Le quality control products,the performance evaluation of 8 items were verified from the perspectives of precision,accuracy,linear range,and clinical reportable range,and freshly collected 211 blood samples were tested and compared on two automatic biochemical analyzers.Results The precision and accuracy verification of 8 items of the Dimension EXL200 automatic biochemical analyzer are all qualified;the 8 items all showed good linear relationship in the analysis and measurement range(R2>0.95,a in the range of 0.97-1.03);the maximum dilution factor verifies that the recovery rate is within the acceptable range,and the clinical reportable range is the upper limit of the analytical measurement range multiplied by the maximum dilution factor;in the comparison test,the data of 8 items of 211 fresh blood samples measured on the two automatic biochemical analyzers were subjected to regression analysis.The results show that the correlation coefficient r value of all test items are greater than 0.9,and the relative bias is less than the bias or the verification value allowed by the laboratory,which indicating that the comparability between the two instruments is good,test results show high consistency,and the comparison test passed.Conclusion The precision,accuracy,linear range,and clinical reportable range of the 8 test items of the Dimension EXL200 automatic biochemical analyzer are verified,which ensuring the accuracy and reliability of the test results;the comparison test shows that the data of the Dimension EXL200 automatic biochemical analyzer is consistent with the detection results of the original automatic biochemical analyzer,which provides a guarantee for the continuous analysis of the data of sports biochemical laboratory.