评估Sebia Capillarys 3 Tera系统和Bio-Rad D-100系统用于测量糖化血红蛋白A1c的性能。

Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 Systems for the Measurement of Hemoglobin A1c.

作者信息

Herpol Margaux, Lanckmans Katrien, Van Neyghem Stefaan, Clement Pascale, Crevits Stefanie, De Crem Kim, Gorus Frans K, Weets Ilse

机构信息

From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.

出版信息

Am J Clin Pathol. 2016 Jul;146(1):67-77. doi: 10.1093/ajcp/aqw081. Epub 2016 Jun 29.

DOI:10.1093/ajcp/aqw081

PMID:27357293

Abstract

OBJECTIVES

We evaluated the Bio-Rad (Irvine, CA) D-100 and the Sebia (Lisses, France) Capillarys 3 Tera for the measurement of hemoglobin A1c (HbA1c) in venous blood samples.

METHODS

Whole-blood samples and control material were analyzed with the D-100 and Capillarys 3 Tera and compared with our routine method, HLC-723G7 (Tosoh, Tokyo, Japan). An evaluation protocol to test precision, trueness, linearity, carryover, and selectivity was set up according to Clinical and Laboratory Standards Institute guidelines. The results were presented in National Glycohemoglobin Standardization Program and International Federation of Clinical Chemistry (IFCC) units.

RESULTS

Both systems showed excellent precision (total coefficients of variation <2%, IFCC) and bias (<0.3% or 3 mmol/mol). Linearity was demonstrated for HbA1c values from 3.8% (18 mmol/mol) to 18.5% (179 mmol/mol). Results were correlated with the routine method using Bland-Altman analysis, showing a mean difference of 0.33% or 3.6 mmol/mol for the D-100 and of 0.25% or 2.6 mmol/mol for the Capillarys 3 Tera vs HLC-723G7. None of the automated instruments were prone to interferences by labile HbA1c (≤10 g/L glucose), carbamylated hemoglobin (≤0.5 mmol/L potassium cyanate), hemoglobin variants, bilirubin (≤15 mg/dL), and triglycerides (≤3,360 mg/dL).

CONCLUSIONS

The Bio-Rad D-100 and the Sebia Capillarys 3 Tera instruments performed well for the determination of HbA1c in terms of quality criteria as well as for sample throughput.

摘要

目的

我们评估了伯乐公司（加利福尼亚州欧文市）的D - 100和赛比公司（法国利斯）的Capillarys 3 Tera用于检测静脉血样本中糖化血红蛋白（HbA1c）的性能。

方法

使用D - 100和Capillarys 3 Tera对全血样本和对照物质进行分析，并与我们的常规方法HLC - 723G7（日本东京东曹公司）进行比较。根据临床和实验室标准协会的指南制定了一个评估方案，以测试精密度、准确性、线性、残留和选择性。结果以国家糖化血红蛋白标准化计划和国际临床化学联合会（IFCC）单位呈现。

结果

两个系统均显示出优异的精密度（总变异系数<2%，IFCC）和偏差（<0.3%或3 mmol/mol）。对于3.8%（18 mmol/mol）至18.5%（179 mmol/mol）的HbA1c值，线性良好。使用Bland - Altman分析将结果与常规方法进行相关性分析，结果显示D - 100与HLC - 723G7相比，平均差异为0.33%或3.6 mmol/mol；Capillarys 3 Tera与HLC - 723G7相比，平均差异为0.25%或2.6 mmol/mol。没有一台自动化仪器容易受到不稳定HbA1c（葡萄糖≤10 g/L）、氨基甲酰化血红蛋白（氰酸钾≤0.5 mmol/L）、血红蛋白变异体、胆红素（≤15 mg/dL）和甘油三酯（≤3360 mg/dL）的干扰。