5水平冰冻混合人血清尿酸候选二级标准物质的研制

doi:10.3969/j.issn.1673-8640.2021.01.021

摘要/Abstract

摘要：

目的研制5水平尿酸（UA）冰冻混合人血清候选二级标准物质,为UA常规检测方法的准确度验证提供稳定和互通性良好的真实值控制品。方法收集无肉眼可见脂血、溶血和黄疸的5个UA浓度混合血清,过滤并分装后,-70 ℃保存。参照《标准物质/标准样品定值的一般原则和统计方法》（简称ISO Guide 35）用常规方法进行均匀性和稳定性研究。3家UA候选参考实验室对血清物质进行定值,定值结果用“靶值±总不确定度（u_CRM）”表示。参照美国国家临床实验室标准委员会EP14-A2文件要求评价互通性。结果血清物质均匀性良好（P>0.05）,瓶间变异均<1%。室温和4 ℃ UA浓度的稳定性能满足日常使用需要,-20 ℃至少可稳定115 d,-70 ℃至少可稳定15个月。5水平物质的定值结果分别为（70.00±3.12）、（281.67±4.69）、（383.00±6.46）、（431.00±9.95）和（520.00±12.10）μmol/L。冰冻混合血清物质在15套UA常规检测系统中的互通性良好。结论研制的5水平冰冻混合人血清UA候选二级标准物质均匀性、稳定性、互通性良好,定值准确。

关键词: 尿酸, 均匀性, 稳定性, 互通性

Abstract:

Objective To prepare five frozen pooled human serum samples as secondary reference materials for uric acid（UA）,which were used to validate trueness of routine methods. Methods Five UA concentrations of fasting fresh serum samples without lipemia,hemolysisorcholoplania were collected selectively,mixed and centrifuged. The supernatants were filtrated,allotted,sealed and stored at -70 °C. The homogeneity and stability of the five frozen pooled serum samples were evaluated according to Reference Materials-General and Statistical Principles for Certification (ISO Guide 35 for short). The materials were assigned values by three candidate reference laboratories. The fixed values of the five serum samples presented as target value ± total uncertainty（u_CRM）. Commutability of the five serum samples was assessed according to the National Committee for Clinical Laboratory Standards EP14-A2. Results The five frozen pooled serum samples were homogeneous（P>0.05）,and the variation between bottles was less than 1%. The stability of UA concentration at room temperature and 4 ℃ could meet the needs of daily use. The samples were stable for at least 115 days at -20 ℃ and 15 months at -70 ℃. The fixed valuesof the five frozen pooled serum samples for UA were (70.00±3.12),(281.67±4.69),(383.00±6.46),(431.00±9.95) and (520.00±12.10) μmol/L. The five frozen pooled serum samples had good commutability among 15 routine analytical systems. Conclusion The fivefrozen pooled serum samples are homogeneous,stable,commutable and well assigned,which can be recommended as secondary reference materials for UA.

Key words: Uric acid, Homogeneity, Stability, Commutability

中图分类号:

R446.1

江雅平, 徐国兵, 刘欧. 5水平冰冻混合人血清尿酸候选二级标准物质的研制[J]. 检验医学, 2021, 36(1): 101-106.

JIANG Yaping, XU Guobing, LIU Ou. Preparation of five frozen pooled human serum samples as secondary reference materials for uric acid[J]. Laboratory Medicine, 2021, 36(1): 101-106.

图/表 7

参考文献 10

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仪器型号	试剂		校准品		质控品
仪器型号	生产者	批号	生产者	批号	生产者	批号
Roche Modular P	Roche	635694	Roche	153318	Roche cfas.	170066
Roche Modular P	Roche	639781	Roche	155208	Roche cfas.	170066
Roche Modular D	Roche	638054	Roche	171683	Roche cfas.	170066
Roche cobas 8000	Roche	640909	Roche	155211	Roche cfas.	170066
Beckman AU5800	Beckman-Coulter	AUZ6556	Beckman-Coulter	1121H	朗道	HN1530、HE1532
Dade RXL-MAX	Dade	GB1144	Dade	OCD030	朗道	HN1530、HE1532
Ortho-Vitros FS	Ortho	241799	Ortho	0149	Ortho	F2271、E2067
Ortho-Vitros 5600	Ortho	242913	Ortho	0150	Ortho	F2271、E2067
Ortho-Vitros 350	Ortho	241779	Ortho	0150	Ortho	F2271、E2067
Ortho-Vitros 950	Ortho	242684	Ortho	0150	Ortho	F2271、E2067
Hitachi 7600	Wako	KF087、EN775	Wako	EE602	朗道	374UN、224UE
Hitachi 7180	Wako	KF087、EN775	Wako	EE602	朗道	611UN、354UE
迪瑞CS-600B	Reebio（宁波瑞源）	2019062401	Reebio	2019052301	朗道	HN1530,HE1532
迈瑞BS-430	中元	190602	朗道	1029UE	朗道	1293UN、1007UE
迪瑞CS-380	迪瑞	20190123	迪瑞	20180921	朗道	1293UN、1007UE

仪器型号	试剂		校准品		质控品
仪器型号	生产者	批号	生产者	批号	生产者	批号
Roche Modular P	Roche	635694	Roche	153318	Roche cfas.	170066
Roche Modular P	Roche	639781	Roche	155208	Roche cfas.	170066
Roche Modular D	Roche	638054	Roche	171683	Roche cfas.	170066
Roche cobas 8000	Roche	640909	Roche	155211	Roche cfas.	170066
Beckman AU5800	Beckman-Coulter	AUZ6556	Beckman-Coulter	1121H	朗道	HN1530、HE1532
Dade RXL-MAX	Dade	GB1144	Dade	OCD030	朗道	HN1530、HE1532
Ortho-Vitros FS	Ortho	241799	Ortho	0149	Ortho	F2271、E2067
Ortho-Vitros 5600	Ortho	242913	Ortho	0150	Ortho	F2271、E2067
Ortho-Vitros 350	Ortho	241779	Ortho	0150	Ortho	F2271、E2067
Ortho-Vitros 950	Ortho	242684	Ortho	0150	Ortho	F2271、E2067
Hitachi 7600	Wako	KF087、EN775	Wako	EE602	朗道	374UN、224UE
Hitachi 7180	Wako	KF087、EN775	Wako	EE602	朗道	611UN、354UE
迪瑞CS-600B	Reebio（宁波瑞源）	2019062401	Reebio	2019052301	朗道	HN1530,HE1532
迈瑞BS-430	中元	190602	朗道	1029UE	朗道	1293UN、1007UE
迪瑞CS-380	迪瑞	20190123	迪瑞	20180921	朗道	1293UN、1007UE

标准物质	瓶间变异/%	MS_among	MS_within	P值	u_bb/ （μmol/L）
C1	0.72	0.459	0.267	0.149	0.253
C2	0.39	1.930	0.900	0.075	0.586
C3	0.38	3.337	1.433	0.055	0.797
C4	0.44	4.978	2.900	0.150	0.832
C5	0.47	8.389	5.200	0.178	1.031

标准物质	瓶间变异/%	MS_among	MS_within	P值	u_bb/ （μmol/L）
C1	0.72	0.459	0.267	0.149	0.253
C2	0.39	1.930	0.900	0.075	0.586
C3	0.38	3.337	1.433	0.055	0.797
C4	0.44	4.978	2.900	0.150	0.832
C5	0.47	8.389	5.200	0.178	1.031

保存时间	C1	C2	C3	C4	C5
0个月	77.5	284.0	382.5	424.0	511.0
1个月	77.5	283.5	380.0	423.5	508.0
1.5个月	76.5	284.0	375.5	420.5	503.0
2个月	76.0	285.0	381.5	424.0	513.5
4个月	78.0	281.0	379.5	420.5	505.0
5个月	76.5	282.0	376.5	421.5	501.0
7个月	77.0	282.5	380.5	423.5	510.0
9个月	77.5	283.5	381.0	423.0	510.0
11个月	76.5	284.0	381.0	422.5	511.5
13个月	77.5	285.0	379.5	424.0	510.0
15个月	76.5	282.0	381.0	424.5	510.5
P值	0.806	0.799	0.626	0.329	0.402
u_lts（15个月）	0.615	1.245	2.010	1.305	3.600