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糖化血红蛋白A1c:两种即时检测设备与实验室分析仪性能比较

Haemoglobin A1c: comparing performance of two point of care devices with laboratory analyser.

作者信息

Wan Mohd Zin Ruziana Mona, Ahmad Kamil Zati Iwani, Tuan Soh Tuan Rosidah, Embong Mustaffa, Wan Mohamud Wan Nazaimoon

机构信息

Department of Diabetes & Endocrine, Cardiovascular Diabetes and Nutrition Research Centre, Institute for Medical Research, Jalan Pahang, Kuala Lumpur, 50588, Malaysia.

出版信息

BMC Res Notes. 2013 Dec 18;6:540. doi: 10.1186/1756-0500-6-540.

Abstract

BACKGROUND

Measurement of HbA1c has been widely used for long-term monitoring and management of diabetes control. There is increasing use of point-of-care (POC) devices for measuring HbA1c where quicker results would allow immediate clinical management decisions to be made. Therefore, it is important to evaluate and compare the performance of such devices to the reference laboratory method.

FINDINGS

A total of 274 venous blood was collected from normal healthy adults during the community screening programmes. The performance of POC devices, Afinion and Quo-test were compared to central laboratory HPLC method; Adams A1c HA 8160. Both POC devices showed good correlation to HA 8160 with r = 0.94 (p < 0.001) and r = 0.95 (p < 0.001) for Afinion and Quo-test respectively. The means difference were statistically higher between POC and HA 8160 with 0.23% (95% CI 0.19-0.26, p < 0.001) and 0.29% (95% CI 0.24-0.34, p < 0.001) for Afinion and Quo-test respectively.

CONCLUSIONS

Both POC devices could be considered in health clinics for diabetes management but not to be used for the diagnostic purposes.

摘要

背景

糖化血红蛋白(HbA1c)的测定已广泛用于糖尿病控制的长期监测和管理。即时检测(POC)设备在测定HbA1c方面的应用越来越多,其更快的检测结果能够使临床医生立即做出管理决策。因此,评估和比较此类设备与参考实验室方法的性能很重要。

研究结果

在社区筛查项目期间,共从正常健康成年人中采集了274份静脉血样。将POC设备Afinion和Quo-test的性能与中心实验室的高效液相色谱法(HPLC)——Adams A1c HA 8160进行了比较。两种POC设备与HA 8160均显示出良好的相关性,Afinion和Quo-test的相关系数r分别为0.94(p < 0.001)和0.95(p < 0.001)。POC设备与HA 8160之间的平均差异具有统计学意义,Afinion和Quo-test分别为0.23%(95%置信区间0.19 - 0.26,p < 0.001)和0.29%(95%置信区间0.24 - 0.34,p < 0.001)。

结论

在健康诊所进行糖尿病管理时可以考虑使用这两种POC设备,但不能用于诊断目的。

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