目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e...目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e 411全自动化学发光分析仪具有良好的线性、准确性和重复性,是临床实验室较理想的免疫分析仪器。展开更多
Objective: to reduce the cost of Roche cobase801 luminescent reagent used in the department and study the feasibility of combining the residual reagents of seven different Roche tumor markers. Methods: the sera of 20 ...Objective: to reduce the cost of Roche cobase801 luminescent reagent used in the department and study the feasibility of combining the residual reagents of seven different Roche tumor markers. Methods: the sera of 20 hospitalized patients on the same day were collected, and 3-4 reagent bottle of the same item and batch number with reagent interface test number of 0 were collected and mixed into 1 bottle. The results of 20 samples of new reagents and mixed reagents were tested on Roche cobase801, and the test results of the two reagents were compared and analyzed. The quality control of original new reagents and combined reagents was monitored simultaneously using Roches tumor marker controls, PreciControlTumorMarkerLevel1 and PreciControlTumorMarkerLevel2. Results: by detecting AFP (alpha-fetoprotein) \TPSA (total prostate specific antigen) \CEA (carcinoembryonic antigen) \CA19-9 (carbohydrate antigen 19-9)\FPSA (free prostate specific antigen) \CA125 (carbohydrate antigen 125)\CA15-3 (carbohydrate antigen 15-3), there was no significant difference between the remaining combined reagent and the original new reagent (p > 0.05). The quality control of the combined reagent with the remaining amount is under control. Conclusion: the residual reagents of Roche cobase801 are well preserved. After 3-4 boxes of the same batch of residual reagents are combined, the quality control can be used as the original reagents under controlled conditions, which can ensure the accuracy of detection results.展开更多
目的探讨天冬氨酸转氨酶(AST)参考方法与常规检测系统Roche Cobas c 501全自动生化分析仪检测AST结果的可比性,为常规检测系统测定结果的正确性和可比性提供依据.方法依据国际临床化学与检验医学联合会(IFCC)推荐的参考测量程序建立AST...目的探讨天冬氨酸转氨酶(AST)参考方法与常规检测系统Roche Cobas c 501全自动生化分析仪检测AST结果的可比性,为常规检测系统测定结果的正确性和可比性提供依据.方法依据国际临床化学与检验医学联合会(IFCC)推荐的参考测量程序建立AST改良参考方法;以改良参考方法作为比较方法(X),Roche Cobas c 501检测系统作为实验方法(Y),参考美国临床实验室标准化委员会(CLSI)EP9-A2文件的要求,分别用以上2种方法检测40份单人份新鲜患者血清的AST,计算2种检测方法的测定结果的相关系数及在不同医学决定水平处的偏倚,并以美国临床实验室改进修正案′88(CLIA′88)规定的1/2允许总误差(TEa)为判断标准,判断常规检测系统Roche Cobas c 501与改良参考方法的可比性.结果常规检测系统Roche Cobas c 501全自动生化分析仪与改良参考方法的回归方程为Y=1.0201 X+0.9684,R2=0.9997,相关性良好,在不同医学决定水平处的相对偏倚均在CLIA′88规定的1/2 TEa内.结论常规检测系统Roche Cobas c 501全自动生化分析仪与改良参考方法的检测结果具有良好的可比性,其可被临床所接受.展开更多
文摘目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e 411全自动化学发光分析仪具有良好的线性、准确性和重复性,是临床实验室较理想的免疫分析仪器。
文摘Objective: to reduce the cost of Roche cobase801 luminescent reagent used in the department and study the feasibility of combining the residual reagents of seven different Roche tumor markers. Methods: the sera of 20 hospitalized patients on the same day were collected, and 3-4 reagent bottle of the same item and batch number with reagent interface test number of 0 were collected and mixed into 1 bottle. The results of 20 samples of new reagents and mixed reagents were tested on Roche cobase801, and the test results of the two reagents were compared and analyzed. The quality control of original new reagents and combined reagents was monitored simultaneously using Roches tumor marker controls, PreciControlTumorMarkerLevel1 and PreciControlTumorMarkerLevel2. Results: by detecting AFP (alpha-fetoprotein) \TPSA (total prostate specific antigen) \CEA (carcinoembryonic antigen) \CA19-9 (carbohydrate antigen 19-9)\FPSA (free prostate specific antigen) \CA125 (carbohydrate antigen 125)\CA15-3 (carbohydrate antigen 15-3), there was no significant difference between the remaining combined reagent and the original new reagent (p > 0.05). The quality control of the combined reagent with the remaining amount is under control. Conclusion: the residual reagents of Roche cobase801 are well preserved. After 3-4 boxes of the same batch of residual reagents are combined, the quality control can be used as the original reagents under controlled conditions, which can ensure the accuracy of detection results.
文摘目的探讨天冬氨酸转氨酶(AST)参考方法与常规检测系统Roche Cobas c 501全自动生化分析仪检测AST结果的可比性,为常规检测系统测定结果的正确性和可比性提供依据.方法依据国际临床化学与检验医学联合会(IFCC)推荐的参考测量程序建立AST改良参考方法;以改良参考方法作为比较方法(X),Roche Cobas c 501检测系统作为实验方法(Y),参考美国临床实验室标准化委员会(CLSI)EP9-A2文件的要求,分别用以上2种方法检测40份单人份新鲜患者血清的AST,计算2种检测方法的测定结果的相关系数及在不同医学决定水平处的偏倚,并以美国临床实验室改进修正案′88(CLIA′88)规定的1/2允许总误差(TEa)为判断标准,判断常规检测系统Roche Cobas c 501与改良参考方法的可比性.结果常规检测系统Roche Cobas c 501全自动生化分析仪与改良参考方法的回归方程为Y=1.0201 X+0.9684,R2=0.9997,相关性良好,在不同医学决定水平处的相对偏倚均在CLIA′88规定的1/2 TEa内.结论常规检测系统Roche Cobas c 501全自动生化分析仪与改良参考方法的检测结果具有良好的可比性,其可被临床所接受.
