Abstract

Background

It is crucial to improve the accuracy of HbA_1c measurement as its essential role in diabetes diagnosis and treatment. We aimed to establish the biological variation (BV) and sigma metrics (SM) models and apply the models to evaluate the analytical performance of HbA_1c in external quality assessment (EQA) program.

Methods

Data of HbA_1c EQA (2021) and internal quality control (IQC) (March–August 2021) were collected. The group-specific bias and coefficient of variance (CV) were computed for measuring systems with laboratory number >9 in EQA program. The analytical bias and CV for individual laboratory were estimated from EQA and IQC data. The CV% and bias% were plotted in the BV-SM models for performance evaluation of measuring system and individual laboratory.

Results

Totally, 380 laboratories participated in EQA program. The overall inter-laboratory CV of five EQA samples ranged from 3.02% to 3.63%. There were five measuring systems that met the minimum performance for 5/5 samples: Arkary, Primus, Roche, Mindray and Tosoh, but none of them achieved the optimum performance. Half of the 196 laboratories that reported IQC and EQA results simultaneously achieved 3σ and minimum performance limits. Further analysis indicated that 88.8%, and 31.6% of the laboratories met the minimum performance for bias and CV, respectively.

Conclusions

The biological variation and sigma metrics are appropriate quality management models for evaluating the performance of HbA_1c in EQA program. The intra-laboratory and inter-laboratory imprecision need to be improved in order to achieve the required analytical goals for diabetes diagnosis.

中文翻译：

---

应用生物变异和 sigma 度量来评估 HbA1c 在外部质量评估中的表现

摘要

背景

作为其在糖尿病诊断和治疗中的重要作用，提高 HbA _{1c测量的准确性至关重要。}我们旨在建立生物变异 (BV) 和 sigma 度量 (SM) 模型，并应用这些模型来评估 HbA _1c在外部质量评估 (EQA) 计划中的分析性能。

方法

收集了 HbA _1c EQA（2021 年）和内部质量控制（IQC）（2021 年 3 月至 8 月）的数据。对于 EQA 程序中实验室编号 >9 的测量系统，计算了组特异性偏差和方差系数 (CV)。从 EQA 和 IQC 数据估计各个实验室的分析偏差和 CV。CV% 和偏差% 绘制在 BV-SM 模型中，用于测量系统和各个实验室的性能评估。

结果

共有 380 个实验室参加了 EQA 项目。五个 EQA 样品的整体实验室间 CV 范围为 3.02% 至 3.63%。有五种测量系统满足 5/5 样品的最低性能要求：Arkary、Primus、Roche、Mindray 和 Tosoh，但没有一个达到最佳性能。在报告 IQC 和 EQA 结果的 196 个实验室中，有一半同时达到了 3σ 和最低性能限值。进一步分析表明，分别有 88.8% 和 31.6% 的实验室达到了偏差和 CV 的最低性能。

结论

生物学变异和 sigma 指标是用于评估 HbA _1c在 EQA 计划中的性能的适当质量管理模型。为了达到糖尿病诊断所需的分析目标，需要改善实验室内和实验室间的不精确性。