Evaluation of the Roche Cobas b 101 Glycosylated Hemoglobin Point-of-Care Analyzer

Chetanand Imrit, V. Neergheen-Bhujun, N. Joonas
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引用次数: 4

Abstract

Background Glycosylated hemoglobin (HbA1c) is a biomarker to assess long-term glycemic control in diabetic patients and has recently been recommended for diagnosis of diabetes. An evaluation of the Roche Cobas b 101 point-of-care (POC) HbA1c analyzer was conducted to assess its analytical performance. Methods Precision and accuracy were estimated by analyzing 2 control samples 11 times for the within-run experiment and over 11 days for the between-batch precision. Agreement was correlated to the laboratory method, Tosoh Biosciences G8 HbA1c analyzer (n = 51; range of results, 4.7%–15.1%), and a POC method, the Siemens DCA Vantage Hemoglobin A1c System, using leftover EDTA samples from laboratory analysis (n = 16; range of results, 5.5%–14.2%). Lot-to-lot reproducibility was investigated using 11 patient samples analyzed with 2 different reagent lots. Interference from the presence of hemoglobin variants was also investigated. Results The Cobas b 101 analyzer showed good precision. Within-run and between-batch coefficient of variations were 1.6% and 3.5% for level 1 control (mean value, 5.2%), and for level 2 control (mean, 10.2%), coefficient of variations were 0.3% for within run and 3% for between batch. The analyzer had a good agreement with both Tosoh G8 (r = 1, P < 0.001) and DCA Vantage (r = 0.99, P < 0.001). Comparison of 2 different reagent lots showed good agreement, and a linearity experiment confirmed the system to be linear for values from 4% to 14%. Compared with the Tosoh G8 values, no interference from common hemoglobin variants was found on the Cobas b 101 analyzer. Conclusions The Cobas b 101 is a reliable POC analyzer showing good correlation with the laboratory method and acceptable precision. The equipment is easy to use and will be suitable for HbA1c testing at pediatric and intensive care units and for mobile screening programs of our health system.
罗氏Cobas b 101糖化血红蛋白即时分析仪的评价
糖化血红蛋白(HbA1c)是评估糖尿病患者长期血糖控制的生物标志物,最近被推荐用于糖尿病的诊断。对罗氏Cobas b101即时护理(POC) HbA1c分析仪进行了评估,以评估其分析性能。方法对2个对照样品进行精密度和准确度评价,运行内分析11次,批间精密度评价11 d。一致性与实验室方法相关,Tosoh Biosciences G8 HbA1c分析仪(n = 51;结果范围,4.7%-15.1%),以及POC方法,即西门子DCA Vantage血红蛋白A1c系统,使用实验室分析剩余的EDTA样品(n = 16;结果范围:5.5%-14.2%)。使用2个不同的试剂批次分析11个患者样本,对批次间的重复性进行了调查。还研究了血红蛋白变异存在的干扰。结果Cobas b101分析仪具有良好的精密度。一级对照的组内和批间变异系数分别为1.6%和3.5%(平均值为5.2%),二级对照的组内变异系数为0.3%,批间变异系数为3%。该分析仪与Tosoh G8 (r = 1, P < 0.001)和DCA Vantage (r = 0.99, P < 0.001)具有良好的一致性。两个不同试剂批次的比较结果显示出良好的一致性,线性实验证实该系统在4%到14%的范围内呈线性。与Tosoh G8值相比,Cobas b 101分析仪未发现常见血红蛋白变异的干扰。结论Cobas b101是一种可靠的POC分析仪,与实验室方法相关性好,精密度可接受。该设备易于使用,适用于儿科和重症监护病房的糖化血红蛋白检测以及我们卫生系统的移动筛查项目。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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