Production of candidate secondary reference material for catalytic activity concentration of alpha-amylase in frozen human serum

doi:10.3969/j.issn.1673-8640.2021.03.005

Abstract

Abstract:

Objective To develop a candidate secondary reference material for the catalytic activity of alpha-amylase in frozen human serum as a standard for value transmission. Methods According to JJF 1343-2012 General and Statistical Principles for Characterization of Reference Materials and JJF 1644-2017 Production of Reference Materials for Clinical Enzymology,the homogeneity,stability and commutability were evaluated. The value of the reference material was determined by 6 China National Accreditation Service（CNAS） accredited reference laboratories. The uncertainties of the certified values were calculated. Results The results of homogeneity and stability were both good. The measured values were in the 95% confidence interval in the 4 conventional detection systems for commutability. The values were （106.3±4.3）U/L（k=2）on level 1 and （268.1±7.9）U/L（k=2）on level 2. Conclusions The candidate secondary reference material of alpha-amylase has promising homogeneity,stability and commutability,and its labeled values are reliable.

Key words: Alpha-amylase, Homogeneity, Stability, Commutability, Reference material

CLC Number:

R446

WANG Jianbing, HAN Liqiao, LIN Haibiao, ZHANG Qiaoxuan, YAN Jun, ZHUANG Junhua, HUANG Xianzhang. Production of candidate secondary reference material for catalytic activity concentration of alpha-amylase in frozen human serum[J]. Laboratory Medicine, 2021, 36(3): 255-258.

项目	组内均方	组间均方	F值	P值	u_{bb,rel /%}
水平1	0.533	0.657	1.232	0.304	0.2
水平2	11.889	19.689	1.656	0.120	0.6

项目	组内均方	组间均方	F值	P值	u_{bb,rel /%}
水平1	0.533	0.657	1.232	0.304	0.2
水平2	11.889	19.689	1.656	0.120	0.6

类别	样本	回归方程	\|β₁\|	t_0.95,n-2·s（b1）	u_rel/%
短期稳定性	水平1	Y=106.6-0.14X	0.140	1.920	1.0
	水平2	Y=267.5+0.076X	0.070	2.000	0.7
长期稳定性	水平1	Y=108-0.002 6X	0.003	0.012	1.4
	水平2	Y=277+0.001 8X	0.002	0.006	0.3
使用时稳定性	水平1（冰箱）	Y=101.8+0.019 5X	0.019	0.020	0.1
	水平1（室温）	Y=101.8-0.032X	0.020	0.173	1.3
	水平2（冰箱）	Y=264.3-0.069X	0.069	0.159	0.5
	水平2（室温）	Y=265.6+0.016 3X	0.016	0.187	0.5

类别	样本	回归方程	\|β₁\|	t_0.95,n-2·s（b1）	u_rel/%
短期稳定性	水平1	Y=106.6-0.14X	0.140	1.920	1.0
	水平2	Y=267.5+0.076X	0.070	2.000	0.7
长期稳定性	水平1	Y=108-0.002 6X	0.003	0.012	1.4
	水平2	Y=277+0.001 8X	0.002	0.006	0.3
使用时稳定性	水平1（冰箱）	Y=101.8+0.019 5X	0.019	0.020	0.1
	水平1（室温）	Y=101.8-0.032X	0.020	0.173	1.3
	水平2（冰箱）	Y=264.3-0.069X	0.069	0.159	0.5
	水平2（室温）	Y=265.6+0.016 3X	0.016	0.187	0.5

检测系统	参考物质	回归方程	r2	95%可信区间上限/ （U/L）	95%可信区间下限/ （U/L）	测量结果/（U/L）
系统1	水平1	Y=0.927 2X+5.149 2	0.999 8	114.2	97.5	102.5
	水平2	Y=0.927 2X+5.149 2	0.999 8	265.5	248.9	257.5
系统2	水平1	Y=1.023 4X+1.201 2	0.999 9	119.2	105.4	107.6
	水平2	Y=1.023 4X+1.201 2	0.999 9	286.2	272.6	275.8
系统3	水平1	Y=1.011 1X-0.212 8	0.999 9	116.3	102.9	108.0
	水平2	Y=1.011 1X-0.212 8	0.999 9	281.3	268.0	268.8
系统4	水平1	Y=0.964 3X+5.131 5	0.999 6	121.7	98.0	106.9
	水平2	Y=0.964 3X+5.131 5	0.999 6	278.9	255.6	269.5

Production of candidate secondary reference material for catalytic activity concentration of alpha-amylase in frozen human serum

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项目	正态分布检验	等精度检验	定值/（U/L）	U_CRM（k=2）/（U/L）
水平1	0.398	0.508 9	106.3	4.3
水平2	0.065	0.423 6	268.1	7.9

项目	正态分布检验	等精度检验	定值/（U/L）	U_CRM（k=2）/（U/L）
水平1	0.398	0.508 9	106.3	4.3
水平2	0.065	0.423 6	268.1	7.9