评价 Olympus AU5400 分析仪上五种常规血糖检测方法，采用美国 CDC 己糖激酶参考方法。

Evaluation of five routine glucose methods on an Olympus AU5400 analyzer using the CDC hexokinase reference method.

机构信息

Department of Clinical Laboratory, Peking University Third Hospital, Beijing, China.

出版信息

Clin Chem Lab Med. 2010 Mar;48(3):361-4. doi: 10.1515/CCLM.2010.018.

DOI:10.1515/CCLM.2010.018

PMID:20170396

Abstract

BACKGROUND

In China, two common methods are used to detect serum glucose, glucose oxidase (GOD) and hexokinase (HK) methods. We evaluated five commercially available glucose reagent kits with the Center of Disease Control (CDC) HK reference method.

METHODS

Five routine methods were compared with the HK reference method according to Clinical and Laboratory Standards Institute (CLSI) guideline (EP9-A2). These five routine methods were performed on an "open channel" Olympus 5400 analyzer.

RESULTS

All five evaluated methods were closely correlated to the reference method (r > 0.9998). Compared to the HK reference method, the Olympus-HK method and Roche-GOD method showed a very small positive bias (mean +/- SD: 0.08 +/- 0.09 mmol/L and 0.03 +/- 0.08 mmol/L); while the Biosino-HK method, Osborne-GOD method and Baiding-GOD method showed a very small negative bias (mean +/- SD: -0.07 +/- 0.06 mmol/L, -0.09 +/- 0.07 mmol/L and -0.01 +/- 0.04 mmol/L).

CONCLUSIONS

All five reagents we evaluated using matching calibrators showed good correlation to the reference method and small bias. These five glucose reagents are acceptable for use in clinical laboratories.

摘要

背景

在中国，检测血清葡萄糖有两种常用的方法，即葡萄糖氧化酶（GOD）法和己糖激酶（HK）法。我们用疾病预防控制中心（CDC）的 HK 参考方法评估了五种市售的葡萄糖试剂。

方法

根据临床和实验室标准协会（CLSI）指南（EP9-A2），将五种常规方法与 HK 参考方法进行比较。这五种常规方法在 Olympus 5400 分析仪的“开放式通道”上进行。

结果

所有五种评估方法与参考方法都有密切的相关性（r > 0.9998）。与 HK 参考方法相比，Olympus-HK 方法和 Roche-GOD 方法显示出非常小的正偏差（均值 +/- SD：0.08 +/- 0.09 mmol/L 和 0.03 +/- 0.08 mmol/L）；而 Biosino-HK 方法、Osborne-GOD 方法和 Baiding-GOD 方法则显示出非常小的负偏差（均值 +/- SD：-0.07 +/- 0.06 mmol/L、-0.09 +/- 0.07 mmol/L 和 -0.01 +/- 0.04 mmol/L）。