两种用于设定和评估糖化血红蛋白（HbA1c）质量目标的模型研究：生物学变异和西格玛度量
Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics.
作者信息
Weykamp Cas, John Garry, Gillery Philippe, English Emma, Ji Linong, Lenters-Westra Erna, Little Randie R, Roglic Gojka, Sacks David B, Takei Izumi
机构信息
Department of Clinical Chemistry and European Reference Laboratory, Location Queen Beatrix Hospital, Winterswijk, the Netherlands;
Norfolk and Norwich University Hospital, Norwich, UK;
出版信息
Clin Chem. 2015 May;61(5):752-9. doi: 10.1373/clinchem.2014.235333. Epub 2015 Mar 3.
BACKGROUND
A major objective of the IFCC Task Force on Implementation of HbA1c Standardization is to develop a model to define quality targets for glycated hemoglobin (Hb A1c).
METHODS
Two generic models, biological variation and sigma-metrics, are investigated. We selected variables in the models for Hb A1c and used data of external quality assurance/proficiency testing programs to evaluate the suitability of the models to set and evaluate quality targets within and between laboratories.
RESULTS
In the biological variation model, 48% of individual laboratories and none of the 26 instrument groups met the minimum performance criterion. In the sigma-metrics model, with a total allowable error (TAE) set at 5 mmol/mol (0.46% NGSP), 77% of the individual laboratories and 12 of 26 instrument groups met the 2σ criterion.
CONCLUSIONS
The biological variation and sigma-metrics models were demonstrated to be suitable for setting and evaluating quality targets within and between laboratories. The sigma-metrics model is more flexible, as both the TAE and the risk of failure can be adjusted to the situation-for example, requirements related to diagnosis/monitoring or international authorities. With the aim of reaching (inter)national consensus on advice regarding quality targets for Hb A1c, the Task Force suggests the sigma-metrics model as the model of choice, with default values of 5 mmol/mol (0.46%) for TAE and risk levels of 2σ and 4σ for routine laboratories and laboratories performing clinical trials, respectively. These goals should serve as a starting point for discussion with international stakeholders in the field of diabetes.
背景
国际临床化学和检验医学联合会（IFCC）糖化血红蛋白（HbA1c）标准化实施工作组的一个主要目标是开发一个模型，以定义糖化血红蛋白的质量目标。
方法
研究了两种通用模型，即生物学变异模型和西格玛度量模型。我们在HbA1c模型中选择变量，并使用外部质量保证/能力验证计划的数据来评估模型在实验室内部和实验室之间设定和评估质量目标的适用性。
结果
在生物学变异模型中，48%的单个实验室和26个仪器组中无一达到最低性能标准。在西格玛度量模型中，总允许误差（TAE）设定为5 mmol/mol（0.46% NGSP）时，77%的单个实验室和26个仪器组中的12个达到了2σ标准。
结论
生物学变异模型和西格玛度量模型被证明适用于在实验室内部和实验室之间设定和评估质量目标。西格玛度量模型更灵活，因为TAE和失败风险都可以根据具体情况进行调整，例如与诊断/监测或国际权威机构相关的要求。为了就HbA1c质量目标的建议达成（国际）共识，工作组建议选择西格玛度量模型，TAE的默认值为5 mmol/mol（0.46%），常规实验室和进行临床试验的实验室的风险水平分别为2σ和4σ。这些目标应作为与糖尿病领域国际利益相关者讨论的起点。
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