张洪瑞 周青雪 程璐

[摘要] 目的 对三种品牌的便携式血糖仪进行临床应用评价，了解临床血糖测定值之间的差异，建立院内血糖仪质量保证体系。 方法 选择15份血糖在0.94～24.78 mmol/L的样本，分别抽取EDTA和肝素抗凝全血。用血糖仪和生化仪测定血糖浓度进行比较。 结果 全院74台血糖仪检测高低浓度样本结果重复性好，CV值在3.68%～5.76%；血糖仪的比对试验通过率分别为96.55%（品牌Ⅰ）、100%（品牌Ⅱ）和100%（品牌Ⅲ）。相关性分析显示血糖仪与生化分析仪的结果有高度正相关，相关系数均大于0.99，具有较好的一致性。配对t检验结果显示不同抗凝全血检测血糖浓度结果差异无统计学意义（P>0.05）。 结论 血糖仪与生化仪检测的血糖结果均具有良好的相关性，但仍有2台品牌Ⅰ的仪器未能通过比对试验，必须重新校准后才能用于临床筛查和治疗监测。因此，必须定期对院内便携式血糖仪进行比对，并建立血糖仪质量保证体系，以保证便携式血糖仪检测结果的准确性。

[关键词] POCT血糖仪；全自动生化仪；比对分析；抗凝剂

[中图分类号] R446.1 [文献标识码] B [文章编号] 1673-9701（2018）25-0135-05

[Abstract] Objective To evaluate the clinical application of three brands of portable blood glucose meters to investigate the difference between observed values of blood glucose and build the quality assurance system of in-hospital blood glucose meters. Methods 15 samples of which the levels of blood glucose ranged 0.94-24.78 mmol/L were selected. EDTA and whole blood with heparin anticoagulant were drawn. The levels assessed by blood glucose meter and biochemical analyzer were compared. Results 74 meters of the hospital showed good repeatability when testing samples of high and low concentration. The value of CV ranged 3.68%-5.76%. Pass rates of compare test of meters were 96.55%（brand Ⅰ）， 100%（brand Ⅱ） and 100%（brand Ⅲ） respectively. Correlation analysis showed the results of meters and analyzer were highly positive related with correlation coefficients more than 0.99， which indicated good consistency. Results of paired t-test showed there were no statistical differences in the blood glucose levels of whole blood with different anticoagulants（P<0.05）. Conclusion There was good correlation in the results of blood glucose assessed by blood glucose meters and biochemical analyzer. There were two meters of brand Ⅰ failing to pass the compare test. They needed to be recalibrated before applied in clinical screening and treatment monitoring. Thus， it is necessary to compare the portable blood glucose meters in hospital regularly and build the quality assurance system to make sure of accuracy of portable blood glucose meters results.

[Key words] POCT blood glucose meter； Automatic biochemical analyzer； Comparative analysis； Anticoagulant

近年來，随着我国经济的快速发展和人民生活水平的提高，糖尿病已成为临床上最常见的慢性疾病之一，我国拥有庞大的糖尿病患者人群并有逐年年轻化的趋势[1，2]。随着高新技术的发展和医学科学的进步，便携式（point-care testing，POCT）血糖仪体积更加小型化，操作更加简便，报告结果即时生成[3]。因此，便携式血糖仪越来越受到人们的青睐。但是在临床实践中，POCT血糖仪品牌复杂，仪器性能与参数存在不可避免的差异，并且环境温度、湿度等因素对不同品牌仪器的影响程度也存在差异[4，5]，因此，便携式血糖仪的检测结果不能得到可靠保证，这将对临床决策及治疗效果产生影响。为……