Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics.
Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics.
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DOI：
10.1373/clinchem.2014.235333
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发表时间：
2015-05
影响因子：
9.3
通讯作者：
IFCC Task Force on Implementation of HbA1c Standardization
中科院分区：
文献类型：
--
作者：
Weykamp C;John G;Gillery P;English E;Ji L;Lenters-Westra E;Little RR;Roglic G;Sacks DB;Takei I;IFCC Task Force on Implementation of HbA1c Standardization
IFCC 实施 HbA1c 标准化工作组的一个主要目标是开发一个模型来定义 HbA1c 的质量目标。研究了两种通用模型，即生物变异模型和西格玛度量模型。选择 HbA1c 模型中的变量，并使用 EQA/PT 程序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。在生物变异模型中，48% 的单个实验室和 26 个仪器组均未达到最低性能标准。在 Sigma-metrics 模型中，总允许误差 (TAE) 设置为 5 mmol/mol (0.46% NGSP)，77% 的单个实验室和 26 个仪器组中的 12 个满足 2 sigma 标准。生物变异和西格玛度量模型被证明适合在实验室内部和实验室之间设定和评估质量目标。 Sigma-metrics 模型更加灵活，因为 TAE 和故障风险都可以根据相关要求进行调整，例如：用于诊断/监测或国家（国际）当局的要求。为了就 HbA1c 质量目标的建议达成国际共识，工作组建议选择 Sigma-metrics 模型作为选择模型，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 2 和 4 sigma。这些目标应作为与糖尿病领域的国际利益相关者讨论的起点。
A major objective of the IFCC Task Force on implementation of HbA1c standardization is to develop a model to define quality targets for HbA1c. Two generic models, the Biological Variation and Sigma-metrics model, are investigated. Variables in the models were selected for HbA1c and data of EQA/PT programs were used to evaluate the suitability of the models to set and evaluate quality targets within and between laboratories. 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 2 sigma criterion. The Biological Variation and Sigma-metrics model 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 requirements related to e.g. use for diagnosis/monitoring or requirements of (inter)national authorities. With the aim of reaching international consensus on advice regarding quality targets for HbA1c, 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 2 and 4 sigma 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.