Verification on the result accuracy of ALP by two routine measurement systems according to IFCC reference method

doi:10.3969/j.issn.1673-8640.2015.01.011

Abstract

Abstract:

Objective To evaluate the accuracy of serum alkaline phosphatase (ALP) determination by routine measurement systems. Methods The fresh serum samples were determined simultaneously by the International Federation and Clinical Chemistry(IFCC) reference method and 2 routine measurement systems (A method and B method). The accuracies were evaluated according to the guideline of EP9-A2, the Clinical and Laboratory Standards Institute(CLSI). Meanwhile, the consistency of results between routine measurement systems and IFCC reference method was evaluated by improved Bland-Altman graphical analysis. The accuracies were evaluated comprehensively. The matrix effects of A and B methods were evaluated according to CLSI EP14-A2. Results The regression equation of A method with IFCC reference method was Y_A = 0.982 9X_IFCC+0.010 8, and the average bias was -1.1%. The regression equation of B method with IFCC reference method was Y_B=0.938 3X_IFCC + 0.012 9, and the average bias was -5.5%. The correlation equation between A method and B method was Y_B=0.955 2X_A+0.001 36, R²=0.997 6. The calibrator matrix effects of both A method and B method were found, and the calibrator matrix effect of A method was more significant. Conclusions The accuracy of A method is consistent with that of IFCC reference method, and the accuracy of B method is inconsistent with that of IFCC reference method.

Key words: Alkaline phosphatase, Measurement system, Reference method, Matrix effect

CLC Number:

Q555

WU Lishan, CHEN Shufen, HU Zhibao, SHEN Min, ZHOU Jun.. Verification on the result accuracy of ALP by two routine measurement systems according to IFCC reference method[J]. Laboratory Medicine, 2015, 30(1): 44-48.

Figures/Tables 9

References 13

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样品	检测次数	参考值(μkat/L)^*	检测结果		结果
样品	检测次数	参考值(μkat/L)^*	测定均值 (μkat/L)		CV(%)
JC-ERM Lot.006	3	2.567±0.083	2.568	0.45	合格
2012年RELA-A	10	10.010	9.892	0.23	合格
2012年RELA-B	10	6.289	6.303	0.31	合格
2012E07	10	1.434	1.460	0.68	合格
2012E08	10	4.335	4.280	0.93	合格

样品	检测次数	参考值(μkat/L)^*	检测结果		结果
样品	检测次数	参考值(μkat/L)^*	测定均值 (μkat/L)		CV(%)
JC-ERM Lot.006	3	2.567±0.083	2.568	0.45	合格
2012年RELA-A	10	10.010	9.892	0.23	合格
2012年RELA-B	10	6.289	6.303	0.31	合格
2012E07	10	1.434	1.460	0.68	合格
2012E08	10	4.335	4.280	0.93	合格

样品	参考值 (μkat/L)^*	参考方法		A法		B法
样品	参考值 (μkat/L)^*	均值(μkat/L)	偏倚(%)^#	均值(μkat/L)	偏倚(%)^#	均值(μkat/L)	偏倚(%)^#
2012年RELA-A	10.010	9.892	-1.18	10.998	9.87	9.853	-1.57
2012年RELA-B	6.289	6.303	0.23	7.079	12.57	6.321	0.50

样品	参考值 (μkat/L)^*	参考方法		A法		B法
样品	参考值 (μkat/L)^*	均值(μkat/L)	偏倚(%)^#	均值(μkat/L)	偏倚(%)^#	均值(μkat/L)	偏倚(%)^#
2012年RELA-A	10.010	9.892	-1.18	10.998	9.87	9.853	-1.57
2012年RELA-B	6.289	6.303	0.23	7.079	12.57	6.321	0.50

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