使用TOSOH G8分析仪稳定HbA1c测量的商业QC的成本效益方法

G. K. Tetteh, Rajeswari Shanmugam, Steven Alderson
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摘要

糖化血红蛋白(HbA1c)是糖尿病诊断和管理的关键生物标志物,因为它指示前2-3个月的血糖控制。从事糖化血红蛋白测量的实验室利用质量控制(QC)来监测所产生结果的精度、准确性和可重复性,这是任何卫生保健实验室不可缺少的一部分。商业公司提供冻干QC材料的目标平均和可接受范围。根据对照说明书,重组后7天稳定。重建的冻干QC材料超过7天的稳定性还没有很好地建立,在文献中有关于重建QC材料在0℃以下温度下的稳定性的空白。本研究的目的是开发一种简单的方法来延长已制成的商用HbA1c冻干QC材料的稳定性,以最大限度地利用它,减少浪费并显著节省成本。临床实验室可以很容易地采用这种方法,因为它易于实施,并且可以延长其重组的冻干质量控制(QC)材料的稳定性更长时间。
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A cost effective method for stabilizing commercial QC for the measurement of HbA1c using TOSOH G8 analyser
Haemoglobin A1c(HbA1c) represents a key biomarker in diabetes diagnosis and management, as it is indicative of glucose control during the preceding 2-3 months. Laboratories undertaking the measurement of HbA1c utilize Quality Controls (QC) to monitor precision, accuracy and reproducibility of results generated which is an integral part of any health care laboratory. Commercial companies supply lyophilised QC materials with Target mean and acceptable range. After reconstitution it is stable for 7 days as per the control inserts. The stability of reconstituted lyophilised QC material beyond 7 days is not well established and there are lacunae in the literature about the stability of reconstituted QC material at temperatures below 0C. The purpose of this study was to develop a simple method to extend the stability of are constituted commercial HbA1c lyophilised QC material in an attempt to maximize its usage, reduce wastage and make significant cost savings. Clinical laboratories could easily adopt this proposed method as it is easy to implement, and would extend the stability of their reconstituted lyophilised Quality Control (QC) material for a much longer period.
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