中国临床实验室使用商业冻干与内部全血对照定量血红蛋白A2和胎儿血红蛋白检测的性能评价:国家外部质量评估数据的12年分析

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Yating Ma, Zhongli Du, Juan Tang, Chengshan Xu, Gaofeng Hu, Yukun Han, Chenbin Li, Jie Ma
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引用次数: 0

摘要

目的:分析实验室在HbA2和HbF检测国家外部质量评价体系(China NEQAS)中的表现,并提出质量改进策略。方法:从2013年至2024年中国NEQAS获取数据,使用商业冻干对照和内部全血对照。分析了方法和仪器的分布。比较了12 年间两种对照和方法-仪器平台之间的实验室间系数变化(cv)和目标值。结果:内部对照在2-8 °C下保持均匀和稳定近一个月,在-80 °C下保持一年。毛细管电泳(CE)成为主导方法,2024年有84.3 %的实验室采用毛细管电泳。对于HbA2,两个EQA对照具有可比的浓度范围和实验室间CVs。HbF内部对照涵盖的病理浓度比商业对照更广泛。CE显示两种分析物的实验室间CVs较低:HbA2分别为2.1±1.8 %和5.5±4.8 %(高效液相色谱,HPLC)和6.5±4.1 %(琼脂糖凝胶电泳,AGE), HbF分别为3.2±1.9 %和5.0±1.6 % (HPLC)和8.6±6.8 % (AGE)。当检测相同的对照时,在不同的方法-仪器平台上观察到最大和最小平均浓度的显著差异(HbF高达10 %)。结论:内部控制具有均匀性、稳定性和内在可交换性,并且具有扩大的浓度范围,可以作为EQA商业控制的可靠替代方案。像CE这样的高精度技术应该受到青睐。此外,标准方法和可交换标准物质的发展对标准化至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Objectives: To analyze the performance of laboratories in the China National External Quality Assessment Scheme (China NEQAS) for HbA2 and HbF testing, and to propose strategies for quality improvement.

Methods: Data were obtained from China NEQAS from 2013 to 2024 using both commercially lyophilized controls and in-house whole blood controls. The distributions of methods and instruments were analyzed. Inter-laboratory coefficient variations (CVs) and target values were compared between two types of controls and between method-instrument platforms over 12 years.

Results: The in-house controls remained homogeneous and stable for almost one month at 2-8 °C and for one year at -80 °C. Capillary electrophoresis (CE) became the dominant method, adopted by 84.3 % of labs in 2024. For HbA2, two EQA controls had comparable concentration ranges and inter-laboratory CVs. HbF in-house controls covered broader pathological concentrations than commercial ones. CE demonstrated lower inter-laboratory CVs for both analytes: HbA2 was 2.1 ± 1.8 % vs. 5.5 ± 4.8 % (high-performance liquid chromatography, HPLC) and 6.5 ± 4.1 % (agarose gel electrophoresis, AGE), while HbF was 3.2 ± 1.9 % vs. 5.0 ± 1.6 % (HPLC) and 8.6 ± 6.8 % (AGE). Significant discrepancies in maximum-to-minimum mean concentrations were observed among different method-instrument platforms when testing the same controls (up to 10 % for HbF).

Conclusions: In-house controls demonstrate homogeneity, stability and intrinsic commutability, and have an expanded concentration range, can serve as a reliable alternative to commercial controls for EQA. High-precision techniques such as CE should be favoured. Furthermore, the development of reference methods and commutable reference materials is essential for standardization.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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