Uncertainty of serum electrolyte determinations based on ion chromatography as reference measurement procedures

doi:10.3969/j.issn.1673-8640.2016.12.017

Abstract

Abstract:

Objective To establish a method for evaluating the uncertainty of serum electrolyte determinations based on ion chromatography as reference measurement procedures.Methods The uncertainties of sodium,potassium,magnesium and calcium determinations in the External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine（RELA）-A 2014 sample were evaluated from peak areas of samples,concentration correction factors of standard solution,correction factor of sample processing and measurement repeatability,according to JJF1059-1999 Evaluation and Expression of Uncertainty in Measurement,JJF1135-2005 Evaluation of Uncertainty in Chemical Analysis Measurement and CNAS-GL06 Guidance on Evaluating the Uncertainty in Chemical Analysis. Results The levels of RELA-A 2014 sample were 3 177.79 mg/L for sodium,228.84 mg/L for potassium,48.95 mg/L for magnesium and 127.01 mg/L for calcium. Standard uncertainties were 5.66,1.38,0.38 and 0.75 mg/L. The expanded uncertainties（k=2） were 11.33,2.76,0.75 and 1.50 mg/L,respectively. Conclusions The uncertainty evaluation reference measurement procedure method has been established for serum electrolyte determinations recommended by the Joint Committee for Traceability in Laboratory Medicine（JCTLM）,which can meet the requirements of serum electrolyte determinations for clinical laboratories.

Key words: Electrolytes, Ion chromatography, Reference measurement procedure, Uncertainty

CLC Number:

R446.1

JIA Jianghua, TU Minmin, SHEN Min, ZOU Jihua, ZHANG Man. Uncertainty of serum electrolyte determinations based on ion chromatography as reference measurement procedures[J]. Laboratory Medicine, 2016, 31(12): 1087-1092.

Figures/Tables 7

项目	计算公式^[8]	计算结果
u_k	u_k=S $1 ∑ (c i - c ?) 2$	1.08×10^-4
$u b 0$	$u b 0$ =S $1 n + 1 ∑ (c i - c ?) 2$	9.86×10^-3
$u k, b 0$	$u k, b 0$ =-S^2×c/∑（c_i-c）²=u_k^2×c	-8.78×10^-7
$C b 0$	$C b 0$ = $?$ f/ $?$ b₀=1	1
C_k	C_k= $?$ f/ $?$ k=c	129.26

项目	计算公式^[8]	计算结果
u_k	u_k=S $1 ∑ (c i - c ?) 2$	1.08×10^-4
$u b 0$	$u b 0$ =S $1 n + 1 ∑ (c i - c ?) 2$	9.86×10^-3
$u k, b 0$	$u k, b 0$ =-S^2×c/∑（c_i-c）²=u_k^2×c	-8.78×10^-7
$C b 0$	$C b 0$ = $?$ f/ $?$ b₀=1	1
C_k	C_k= $?$ f/ $?$ k=c	129.26

项目	分量测定值	分量标准不确定度
标准物质纯度（%）	p=39.274 7	u_p=0.003 75
质量（g）	m_标准=1.910 27	um_标准=7.07×10^-6
	m_{50 mL}=50.032 39	um_{50 mL}=3.54×10^-5
	m_梯度2=0.497 54	um_梯度2=7.07×10^-6
体积（mL）	V_{500 mL}=500	uV_{500 mL}=0.250 10
	V_{50 mL}=50	uV_{50 mL}=0.031 70
	V_{25 mL}=25	uV_{25 mL}=0.017 23

项目	分量测定值	分量标准不确定度
水密度（g/mL）	ρ=0.998 443	u_ρ=5×10^-6
质量（g）	m_水=4.992 05	$u m 水$ =7.07×10^-6
	m_{1 mL}=1.039 78	$u m 1 mL$ =7.07×10^-6
	m_{10 mL}=10.224 90	$u m 10 mL$ =2.12×10^-5
体积（mL）	V_{10 mL}=10	$u V 10 mL$ =0.009 50
	V_{25 mL}=25	$u V 25 mL$ =0.017 23

项目	分量测定值	分量标准不确定度
水密度（g/mL）	ρ=0.998 443	u_ρ=5×10^-6
质量（g）	m_水=4.992 05	$u m 水$ =7.07×10^-6
	m_{1 mL}=1.039 78	$u m 1 mL$ =7.07×10^-6
	m_{10 mL}=10.224 90	$u m 10 mL$ =2.12×10^-5
体积（mL）	V_{10 mL}=10	$u V 10 mL$ =0.009 50
	V_{25 mL}=25	$u V 25 mL$ =0.017 23

参数	灵敏系数	不确定度
A=35.152 μs·min	C_A=90.45	u_A=8.09×10^-3μs·min
f_c=1	C_fc=3 177.74	u_fc=1.07×10^-3
f_m=24.58	C_fm=129.28	u_fm=0.031 37
b₀=0.018 4	$C b 0$ =-90.45	$u b 0$ =9.86×10^-3
k=0.271 76	C_k=-11 693.20	u_k=1.08×10^-4

参数	灵敏系数	不确定度
A=35.152 μs·min	C_A=90.45	u_A=8.09×10^-3μs·min
f_c=1	C_fc=3 177.74	u_fc=1.07×10^-3
f_m=24.58	C_fm=129.28	u_fm=0.031 37
b₀=0.018 4	$C b 0$ =-90.45	$u b 0$ =9.86×10^-3
k=0.271 76	C_k=-11 693.20	u_k=1.08×10^-4

项目	年份	样本	测定值（mg/L）	CV（%）	靶值（mg/L）^*	偏移（%）	等效限（%）^[9]
钠离子	2013	RELA-A	2 906.74	0.19	2 914.79	-0.28	±1.25
		RELA-B	2 995.06	0.13	2 987.24	0.26
	2014	RELA-A	3 177.79	0.08	3 179.98	-0.07
		RELA-B	3 466.97	0.05	3 477.60	-0.31
钾离子	2013	RELA-A	145.98	0.28	146.21	-0.16	±2.00
		RELA-B	261.53	0.18	260.95	0.22
	2014	RELA-A	228.84	0.11	229.24	-0.17
		RELA-B	114.68	0.38	114.58	0.09
镁离子	2013	RELA-A	34.44	0.18	34.39	0.14	±3.75
		RELA-B	33.05	0.08	32.78	0.81
	2014	RELA-A	48.96	0.04	48.77	0.39
		RELA-B	23.47	0.21	23.59	-0.51
钙离子	2013	RELA-A	102.52	0.15	103.28	-0.74	±2.50
		RELA-B	115.52	0.37	115.2	0.28
	2014	RELA-A	127.01	0.05	126.12	0.70
		RELA-B	73.28	0.28	73.04	0.33

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