基于护士的即时糖化血红蛋白检测评估

Nurse-based evaluation of point-of-care assays for glycated haemoglobin.

作者信息

St John Andrew, Davis Timothy M E, Goodall Ian, Townsend Mary Anne, Price Christopher P

机构信息

ARC Consulting, Perth, W Australia 6050, Australia.

出版信息

Clin Chim Acta. 2006 Mar;365(1-2):257-63. doi: 10.1016/j.cca.2005.09.003. Epub 2005 Oct 3.

DOI:10.1016/j.cca.2005.09.003

PMID:16202401

Abstract

BACKGROUND

Various devices are now available to measure glycated haemoglobin (HbA1c) outside of the laboratory. The aim of this study was to assess the performance of these point-of-care instruments in the hands of non-laboratory trained personnel.

METHODS

Two nursing staff tested samples from patients attending a diabetes research clinic using the following point-of-care devices for HbA1c-Metrica A1C Now, Bayer DCA 2000, Cholestech GDX and Axis-Shield Nycocard HbA1c. In addition they performed regular analysis of quality control samples. The effects on analytical performance of multiple operators as well as laboratory-trained staff, were also assessed. All measurements were compared to a boronate-affinity HPLC method in the central laboratory.

RESULTS

The mean HbA1c difference of the point-of-care devices compared to the laboratory reference method ranged from -0.31% to +0.39%. Only the DCA device had a between batch imprecision of less than 5%. The analytical performance obtained by laboratory staff was similar to nursing staff for 3 devices and better for the Nycocard device.

CONCLUSIONS

On the basis of the results obtained by nursing staff, only the DCA of the devices tested, can be recommended for measurement of HbA1c outside of the laboratory.

摘要

背景

目前有多种设备可用于在实验室外测量糖化血红蛋白（HbA1c）。本研究的目的是评估这些即时检测仪器在未经实验室培训人员手中的性能。

方法

两名护理人员使用以下用于HbA1c的即时检测设备，对糖尿病研究诊所患者的样本进行检测——美迪卡A1C即时检测仪、拜耳DCA 2000、胆固醇技术公司GDX和Axis-Shield Nycocard HbA1c检测仪。此外，他们还对质量控制样本进行常规分析。还评估了多个操作人员以及经过实验室培训的人员对分析性能的影响。所有测量结果均与中心实验室的硼酸亲和高效液相色谱法进行比较。