罗氏Cobas8000全自动生化分析仪检测心肌酶谱的性能评价

目的对在罗氏公司Cobas8000型全自动生化分析仪上检测的心肌酶谱:天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)的分析性能进行评价。方法参考美国临床和实验室标准化协会性能评价方法和相关报道,并根据临床需求和实际要求,对罗氏公司Cobas8000型全自动生化分析仪测定血清心肌酶谱的准确度、精密度、线性范围、生物参考区间和最大稀释倍数5项分析性能进行验证和评价,并与强生公司Vitro5600型分析仪进行方法学比对。结果罗氏Cobas8000分析仪对心肌酶谱的检测准确度较好,各项指标的相对偏倚均小于允许总误差的1/2,符合美国临床实验室改进修正法案(CLIA′88)的指标要求。精密度验证结果显示批内变异系数和不同批次之间的检测标本变异系数分别小于允许总误差的1/4和1/3。线性回归方程的斜率在0.998~1.017,r 2均≥0.995。AST、LDH、CK、CK-MB的临床可报告范围分别为2~700 U/L、10~1000 U/L、7~2000 U/L、3~2000 U/L。参考范围验证除LDH有一个值超出该参考区间外,其他结果均在参考范围内。高浓度的标本可经稀释后再行测定,测定结果表明4项测定指标的相对偏差在允许误差范围内,具有较高的临床参考价值。实验室内结果比对,4个项目比对结果均符合CLIA′881/2允许偏倚,与Vitro5600型分析仪具有良好的一致性。结论罗氏Cobas8000型全自动生化分析仪检测心肌酶谱的主要分析性能均符合厂商声明的性能和有关的质量要求,检测结果准确性较高、可靠性较好,临床参考价值较高,故可满足临床需求。

Performance evaluation of Roche Cobas8000 automatic biochemical analyzer for detecting myocardial enzymes spectrum

Objective To evaluate the performance verification of serum myocardial enzymes spectrum(AST,LDH,CK,CK-MB)detected by Roche Cobas8000 automatic biochemical analyzer.Methods According to clinical and practical requirements,the accuracy and precision of AST,LDH,CK,CK-MB were detected by Cobas8000,and its linear range,biological reference range and maximum dilution multiple were evaluated referring to the evaluation method of the American association of clinical and laboratory standards.Meanwhile the methodological comparison with Johnson Vitro5600 analyzer was also carried out.Results The Roche Cobas8000 analyzer had a good accuracy in detecting myocardial enzyme spectrum.The relative bias of the 4 indexes was less than the 1/2 of allowed total error,which was in line with the requirements of the CLIA′88.The within-run precision and the between-run precision of the 4 items(AST,LDH,CK,CK-MB)of Cobas 8000 analyzer were less than the 1/4 and 1/3 of allowed total error,respectively.The slopes of linear regression equation were 0.998-1.017,r 2≥0.995.The clinical reportable ranges of AST,LDH,CK and CK-MB were 2-700 U/L,10-1000 U/L,7-2000 U/L,3-2000 U/L.Reference range validation results showed that except for a value beyond the reference interval of LDH,all other results were within the scope of reference.The samples of high concentration could be measured after dilution,and the results showed that the relative deviation of the 4 items was within the allowable error range,and had a high clinical reference value.The results of laboratory comparison showed that the comparison of the 4 items accorded with the CLIA′881/2 allowed total error and was in good agreement with the Vitro5600 analyzer.Conclusion The main analysis performance of Roche Cobas8000 automatic biochemical analyzer in the detection of myocardial enzyme spectrum is consistent with the performance and related quality requirements of the manufacturer.The accuracy and reliability of the test is high and good,meanwhile the clinical reference value is high,so it can meet the clinical needs.