一种用于糖尿病护理的高通量检测：新一代罗氏Cobas c 513糖化血红蛋白检测的评估

A high-throughput test for diabetes care: An evaluation of the next generation Roche Cobas c 513 hemoglobin A assay.

作者信息

Gifford Jessica L, Higgins Trefor, Sadrzadeh S M Hossein

机构信息

Calgary Laboratory Services, 9, 3535 Research Rd NW, Calgary, AB, T2L 2K8, Canada.

Department of Pathology and Laboratory Medicine, University of Calgary, Health Sciences Centre, 3330 Hospital Drive NW, Calgary, Alberta, T2N 4N1, Canada.

出版信息

Pract Lab Med. 2019 Nov 9;17:e00147. doi: 10.1016/j.plabm.2019.e00147. eCollection 2019 Nov.

DOI:10.1016/j.plabm.2019.e00147

PMID:31799362

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6881683/

Abstract

OBJECTIVES

The level of glycated hemoglobin A (HbA) in blood is the preferred marker for diabetes monitoring and treatment. Here, we evaluate the analytical performance of the Roche Diagnostics Cobas c 513, a stand-alone HbA immunoassay analyzer.

DESIGN AND METHODS

Performance was assessed with regards to imprecision, accuracy, linearity, method comparison against the Roche Cobas Integra 800 CTS, specimen stability, interference from common hemoglobin variants and hemoglobin F, and throughput.

RESULTS

Within-run and between-run precisions were 0.5-0.7 and 0.8-1.3%CV, respectively. An average bias of -1.6% to proficiency survey samples was observed. The c 513 correlated well with the Integra (slope = 0.94, -intercept = 0.50, and correlation coefficient = 0.998). The effect of hemoglobin variants on this assay was negligible while specimens containing ≥10% HbF demonstrated a negative bias. The c 513 instrument can process up to 340 samples per hour.

CONCLUSIONS

The c 513 is a precise, accurate, automated high throughput analyzer for measuring HbA in large laboratories.

摘要

目的

血液中糖化血红蛋白A（HbA）水平是糖尿病监测和治疗的首选标志物。在此，我们评估罗氏诊断公司的Cobas c 513，一款独立的HbA免疫分析分析仪的分析性能。

设计与方法

从精密度、准确性、线性、与罗氏Cobas Integra 800 CTS的方法比较、样本稳定性、常见血红蛋白变异体和血红蛋白F的干扰以及通量等方面评估性能。

结果

批内和批间精密度分别为0.5 - 0.7%CV和0.8 - 1.3%CV。观察到与能力验证样本的平均偏差为 -1.6%。c 513与Integra相关性良好（斜率 = 0.94，截距 = 0.50，相关系数 = 0.998）。血红蛋白变异体对该检测的影响可忽略不计，而含有≥10% HbF的样本表现出负偏差。c 513仪器每小时最多可处理340个样本。