迈瑞H50糖化血红蛋白分析仪性能评价

doi:10.3969/j.issn.1673-8640.2017.12.016

摘要/Abstract

摘要：

目的全面评价迈瑞H50糖化血红蛋白分析仪（简称H50）的临床性能,确认该仪器是否能满足临床应用要求。方法依据我国卫生行业标准YY/T1246—2014《糖化血红蛋白分析仪》、WS/T 461—2015《糖化血红蛋白检测》和美国临床实验室标准化协会（CLSI）EP5-A2、EP6-A、EP9-A3文件的要求对H50的携带污染率、重复性、批内精密度、批间精密度、室内精密度、线性范围、与对比仪器[BIO-RAD VariantⅡ糖化血红蛋白分析仪（简称VariantⅡ）]的可比性、正确度、样本稳定性、干扰试验及在扩展模式下对血红蛋白E（HbE）的识别能力等项目进行评价。结果 H50检测糖化血红蛋白（HbA_1c）的携带污染率低（-0.56%）,高值样本对低值样本无携带污染;重复性结果显示不同浓度样本变异系数（CV）均<1%,批内、批间及室内精密度（CV）均<1%,低于WS/T 461—2015的要求;具有较宽的检测线性范围（4.2%~16.6%）,可覆盖绝大多数患者的检测结果。样本在低温环境（4 ℃）及常温环境（18~24 ℃）保存6 d,结果仍然稳定。采用国际临床化学和检验医学联合会（IFCC）标准品进行正确度验证,绝对偏差在±0.3%HbA_1c内。与VariantⅡ的检测结果呈正相关（r=0.996）,医学决定水平处的预期偏移<1%,低于美国病理学家协会（CAP）的要求（6%）。甘油三酯（TG）、胆红素及葡萄糖（Glu）对H50检测HbA_1c不存在干扰。采用扩展模式可有效提示HbE。结论 H50具有优异的性能,可满足HbA_1c临床检测的需要。

关键词: 糖化血红蛋白, 糖化血红蛋白分析仪, 性能评价

Abstract:

Objective To evaluate the performance of Mindray automatic H50 glycohemoglobin analyzer,and to confirm whether it meets clinical requirements. Methods According to guidelines published by the People's Republic of China health industry standard YY/T1246—2014 Glycohemoglobin Analyzer,WS/T 461—2015 Measurement of Hemoglobin A1 and the Clinical and Laboratory Standards Institute（CLSI） EP5-A2,EP6-A and EP9-A3,the carryover rate,repeatability,within-run precision,between-run precision,within-laboratory precision,linearity,comparability with BIO-RAD VariantⅡ glycohemoglobin analyzer,trueness,sample stability,interference and glycated hemoglobin E（HbE） identification were evaluated. Results The carryover rate of H50 for the determination of glycated hemoglobin A_1c（HbA_1c） was low（-0.56%）,and high-value samples were not carried to low-value samples. The results of repeatability showed that the coefficient of variation（CV） was <1%. The within-run precision,between-run precision and within-laboratory precision（CV） were <1%,which met the requirements of WS/T 461—2015. There was a wide linear range（4.2%-16.6%）,which can cover the majority of samples. The samples after storing in cold environment（4 ℃） and room temperature（18-24 ℃） were stable for 6 d. According to the requirements of the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）,the absolute bias was within ±0.3% HbA_1c. There was a positive relation with VariantⅡ（r=0.996）. The expected bias at medical decision level was <1% below the requirements of the College of American Pathologists（CAP）（6%）. Triglyceride（TG）,bilirubin and glucose（Glu） had no interference to HbA_1c. The extended model can effectively prompt for HbE. Conclusions H50 glycohemoglobin analyzer has good performance,which can meet clinical requirements.

Key words: Glycated hemoglobin A_1c, Glycohemoglobin analyzer, Performance evaluation

中图分类号:

R446.1

赵智赟, 袁文华, 宋云霄. 迈瑞H50糖化血红蛋白分析仪性能评价[J]. 检验医学, 2017, 32(12): 1137-1142.

ZHAO Zhiyun, YUAN Wenhua, SONG Yunxiao. Performance of Mindray automatic H50 glycohemoglobin analyzer[J]. Laboratory Medicine, 2017, 32(12): 1137-1142.

图/表 12

参考文献 12

[1]	World Health Organization.Use of glycated haemoglobin(HbA1c) in the diagnosis of diabetes mellitus:abbreviated report of a WHO consultation[R]. Geneva:WHO,2011.
[2]	Standards of medical care in diabetes-2016:summary of revisions[J]. Diabetes Care,2016,39(Suppl 1):S4-S5.
[3]	吴炯,邵文琦,周琰,等. 上海地区糖化血红蛋白一致性计划建立和结果初步评价[J]. 中华检验医学杂志,2012,35(4):370-372.
[4]	邵文琦,孙林,王蓓丽,等. 上海地区糖化血红蛋白一致性计划研究进展[J]. 检验医学,2015,30(9):948-952.
[5]	中华人民共和国医药行业标准. YY/T1246—2014 糖化血红蛋白分析仪[S]. 2014.
[6]	Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods[S]. EP5-A2,CLSI,2004.
[7]	Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures[S]. EP6-A,CLSI,2003.
[8]	Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples[S]. EP9- A3,CLSI,2013.
[9]	LITTLE R. College of American Pathologists(CAP) GH5 survey data [EB /OL].(2015-08-15) [2017-07-05]. .
[10]	中华人民共和国医药行业标准.WS/T461—2015 糖化血红蛋白检测[S]. 2015.
[11]	NATHAN D M,KUENEN J,BORG R,et al.Translating the A1C assay into estimated average glucose values[J]. Diabetes Care,2008,31(8):1473-1478.
[12]	LENTERS-WESTRA E,SLINGERLAND R J.Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria[J]. Clin Chem,2014,60(8):1062-1072.

序号	$\overline{x}$	s	CV	极差
样本1	6.11	0.02	0.37	0.1
样本2	9.95	0.06	0.61	0.2
样本3	7.31	0.04	0.54	0.2

序号	$\overline{x}$	s	CV	极差
样本1	6.11	0.02	0.37	0.1
样本2	9.95	0.06	0.61	0.2
样本3	7.31	0.04	0.54	0.2

HbA_1c	$\overline{x}$	批内精密度	批间精密度	室内精密度
水平1	5.98	0.67	0.33	0.84
水平2	12.69	0.32	0.24	0.47

HbA_1c	$\overline{x}$	批内精密度	批间精密度	室内精密度
水平1	5.98	0.67	0.33	0.84
水平2	12.69	0.32	0.24	0.47

稀释比例	第1次	第2次	第3次	$\overline{x}$
4∶0	4.3	4.3	4.3	4.3
3∶1	7.6	7.5	7.5	7.5
2∶2	11.2	10.9	10.9	11.0
1∶3	14.3	14.0	14.0	14.1
0∶4	16.9	16.8	16.9	16.9