2016年上海地区肌酐、尿酸、尿素正确度验证结果分析

doi:10.3969/j.issn.1673-8640.2018.04.017

摘要/Abstract

摘要：

目的分析上海地区2016年度小分子正确度验证数据,了解上海地区临床实验室肌酐（Cr）、尿酸（UA）、尿素（Urea）的检测质量。方法收集临床实验室检验剩余样本,制备高、低2个水平的冰冻混合人血液样本。临床实验室在不同工作日对样本进行重复检测,通过网络回报结果。采用参考方法对样本进行赋值,分析所有回报结果的临床实验室3个项目的室内变异系数（CV）、偏移及按不同系统分组后的CV、偏移。结果按仪器进行分组,Cr-2016A、Cr-2016B、UA-2016A、UA-2016B、Urea-2016A、Urea-2016B测定结果与靶值的偏移分别为-5.54%~0.62%、-5.34%~2.89%、-1.43%~2.62%、-1.49%~3.73%、-1.74%~0.81%、-0.08%~1.16%。以参考方法定值结果为靶值,并以临床生物化学检验常规项目分析质量指标（WS/T 403—2012）中偏移的标准来评价回报结果的临床实验室的不合格率,Cr 2个水平分别有17.14%、7.14%的实验室不合格;UA 2个水平分别有10.00%、14.29%的实验室不合格;Urea 2个水平分别有为41.43%、37.14%的实验室不合格。结论上海地区大部分临床实验室检测Cr、UA的正确度水平符合标准,Urea的正确度水平还需改进。

关键词: 肌酐, 尿酸, 尿素, 参考方法, 正确度验证

Abstract:

Objective To evaluate the determination quality of creatinine（Cr）,uric acid（UA） and urea（Urea） determinations in clinical laboratories,through analyzing the results of small molecule determination trueness verification in Shanghai,2016. Methods Remaining samples from clinical laboratories were collected,and high-level and low-level frozen mixed blood samples were prepared. These samples were determined repeatedly in different working days,and the results were returned through network. Reference methods were used to assignment simultaneously. Biases and coefficients of variation（CV） of the 3 parameters were obtained and analyzed according to different instrument systems. Results According to different instrument systems,the bias between Cr-2016A determination results and target value was -5.54%-0.62%,and that between Cr-2016B determination results and target value was -5.34%-2.89%. The bias between UA-2016A determination results and target value was -1.43%-2.62%,and that between UA-2016B determination results and target value was -1.49%-3.73%. The bias between Urea-2016A determination results and target value was -1.74%-0.81%,and that between Urea-2016B determination results and target value was -0.08%-1.16%. The performance was assessed according to the criterion listed in the analytical quality specification for routine analysis in clinical biochemistry （WS/T 403—2012） and the target value by reference methods. The failure ratios of Cr determination in high-level and low-level frozen mixed blood samples were 17.14% and 7.14%,the failure ratios of UA determination were 10.00% and 14.29%,and the failure ratios of Urea determination were 41.43% and 37.14%,respectively. Conclusions The accuracies of Cr and UA can meet related requirements in most clinical laboratories. However,the determination quality of Urea still should be improved.

Key words: Creatinine, Uric acid, Urea, Reference method, Trueness verification

中图分类号:

R446.1

金中淦, 居漪, 李卿, 唐立萍, 虞啸炫, 刘文彬, 欧元祝. 2016年上海地区肌酐、尿酸、尿素正确度验证结果分析[J]. 检验医学, 2018, 33(4): 348-352.

JIN Zhonggan, JU Yi, LI Qing, TANG Liping, YU Xiaoxuan, LIU Wenbin, OU Yuanzhu. Analysis on the results of creatinine,uric acid and urea determination trueness verification in Shanghai,2016[J]. Laboratory Medicine, 2018, 33(4): 348-352.

图/表 5

参考文献 9

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[6]	金中淦,居漪,唐立萍,等. 尿素参考方法建立及在正确度验证中的应用[J]. 临床检验杂志,2016,34(12):897-900.
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项目	测定均值	参考值
Cr（μmol/L）	72.12	72.89±1.61
UA（μmol/L）	274.96	278±6
Urea（mmol/L）	4.29	4.321±0.089

项目	测定均值	参考值
Cr（μmol/L）	72.12	72.89±1.61
UA（μmol/L）	274.96	278±6
Urea（mmol/L）	4.29	4.321±0.089

仪器	偏移						CV
系统	Cr-2016A	Cr-2016B	UA-2016A	UA-2016B	Urea-2016A	Urea-2016B	Cr-2016A	Cr-2016B	UA-2016A	UA-2016B	Urea-2016A	Urea-2016B
1	-3.25	-5.12	-0.28	-0.52	0.25	0.54	6.25	1.65	2.56	2.45	4.22	3.94
2	-2.55	-2.16	1.3	1.19	-1.09	0.17	3.22	3.18	2.39	2.97	3.94	3.5
3	-5.54	-5.34	2.62	1.26	-1.74	-0.58	6.07	4.72	2.05	3.02	1.24	1.65
4	-0.54	-0.97	1.51	3.73	0.11	-0.08	1.83	1.69	2.07	1.31	4.07	2.85
5	0.1	2.89	-0.23	-1.48	-0.66	0.15	3.32	0.92	0.55	2.45	3.64	0.53
6	0.62	-1.16	2.28	1.9	0.19	1.16	4.62	3.55	3.22	3.65	1.89	1.85
7	-4.44	-4	0.01	-0.56	0.42	0.48	2.68	2.14	4.72	3.84	2.39	2.78
8	-2.64	-2.34	-0.14	-0.31	0.81	0.09	2.78	2.94	2.99	2.64	4.32	4.15
9	0.3	-1.31	-1.43	-1.49	0.47	0.49	1.71	1.19	0.54	0.85	2.47	3.28
10	-0.75	-1.94	0.03	-0.19	-0.92	-0.09	3.86	2.37	3.24	3.19	4.98	3.98

仪器	偏移						CV
系统	Cr-2016A	Cr-2016B	UA-2016A	UA-2016B	Urea-2016A	Urea-2016B	Cr-2016A	Cr-2016B	UA-2016A	UA-2016B	Urea-2016A	Urea-2016B
1	-3.25	-5.12	-0.28	-0.52	0.25	0.54	6.25	1.65	2.56	2.45	4.22	3.94
2	-2.55	-2.16	1.3	1.19	-1.09	0.17	3.22	3.18	2.39	2.97	3.94	3.5
3	-5.54	-5.34	2.62	1.26	-1.74	-0.58	6.07	4.72	2.05	3.02	1.24	1.65
4	-0.54	-0.97	1.51	3.73	0.11	-0.08	1.83	1.69	2.07	1.31	4.07	2.85
5	0.1	2.89	-0.23	-1.48	-0.66	0.15	3.32	0.92	0.55	2.45	3.64	0.53
6	0.62	-1.16	2.28	1.9	0.19	1.16	4.62	3.55	3.22	3.65	1.89	1.85
7	-4.44	-4	0.01	-0.56	0.42	0.48	2.68	2.14	4.72	3.84	2.39	2.78
8	-2.64	-2.34	-0.14	-0.31	0.81	0.09	2.78	2.94	2.99	2.64	4.32	4.15
9	0.3	-1.31	-1.43	-1.49	0.47	0.49	1.71	1.19	0.54	0.85	2.47	3.28
10	-0.75	-1.94	0.03	-0.19	-0.92	-0.09	3.86	2.37	3.24	3.19	4.98	3.98

项目	靶值	允许偏移（%）	允许范围	不合格实验室[家（%）]
Cr-2016A（μmol/L）	142.16	5.5	134.34~149.98	12（17.14）
Cr-2016B（μmol/L）	304.27	5.5	287.54~321.00	5（7.14）
UA-2016A（μmol/L）	351.14	4.5	335.34~366.94	7（10）
UA-2016B（μmol/L）	581.58	4.5	555.41~607.75	10（14.29）
Urea-2016A（mmol/L）	7.94	3	7.70~8.18	29（41.43）
Urea-2016B（mmol/L）	15.63	3	15.16~16.10	26（37.14）