3款床旁糖化血红蛋白检测系统社区人群适用性研究

目的 研究3款血红蛋白(HbA1c)床旁检测(Point of care testing, POCT)系统在社区医疗机构的适用性.方法 收集658例社区临床机构EDTA抗凝全血标本,借助可溯源的二级参考测量程序(SRMP)结果将人群进行分组比较,得出3款POCT HbA1c检测系统在临床检测的一致性.并采用受试者工作曲线(ROC)评价各检测系统在临床诊断关键点的灵敏度和特异性.结果 POCT HbA1c-1、2、3 与溯源到IFCC参考方法的SRMP检测结果Kappa一致性分析结果为,κPOCT-1=0.828、κPOCT-2=0.794、κPOCT-3=0.756;ROC曲线下面积(AUC)分别为0.900、0.901、0.898;在临床诊断切点6.5%处,灵敏度分别为87.0%、83.8%、84.8%,特异性分别为78.8%、81.9%、81.0%;结论 3款POCT HbA1c检测系统在社区人群检测中,均具有良好的灵敏度、特异性和检测一致性,适用于临床使用.

The Study of the Application of the 3 POCT HbA1cInstruments in Community Clinics

Objective To evaluate the applicability of 3 hemoglobin A1c (HbA1c) point-of-care testing (POCT) instruments in community medical institutions.Methods The 658 subjects from community medical institutions were collected with their EDTA-antcoagulated whole blood specimens.The sensitivity and specificity of the key points in the clinical diagnosis were evaluated by the receiver operating characteristic (ROC) curve.The results were compared with the clinical diagnosis and the traceable secondary reference measurement procedure (SRMP).The consistency of the 3 POCT HbA1c was obtained.Results The results of κ test for consistency analysis were κPOCT-1=0.828, κPOCT-2=0.794 and κPOCT-3=0.756;The area under the ROC curve of the POCT HbA1c-1,2,3 were 0.900, 0.901 and 0.898 respectively.The sensitivity were 87.0%,83.8% and 84.8% and specificity were 78.8%, 81.9%, and 81.0% respectively at the key point of 6.5%.Conclusion 3 POCT HbA1c testing systems have good sensitivity, specificity and consistency, and they were suitable for clinical use in the community medical institutions.