Yating Ma, Zhongli Du, Juan Tang, Chengshan Xu, Gaofeng Hu, Yukun Han, Chenbin Li, Jie Ma
{"title":"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","authors":"Yating Ma, Zhongli Du, Juan Tang, Chengshan Xu, Gaofeng Hu, Yukun Han, Chenbin Li, Jie Ma","doi":"10.1515/cclm-2025-0683","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To analyze the performance of laboratories in the China National External Quality Assessment Scheme (China NEQAS) for HbA<sub>2</sub> and HbF testing, and to propose strategies for quality improvement.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 HbA<sub>2</sub>, 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: HbA<sub>2</sub> 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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Performance evaluation of quantitative hemoglobin A<sub>2</sub> 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.\",\"authors\":\"Yating Ma, Zhongli Du, Juan Tang, Chengshan Xu, Gaofeng Hu, Yukun Han, Chenbin Li, Jie Ma\",\"doi\":\"10.1515/cclm-2025-0683\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To analyze the performance of laboratories in the China National External Quality Assessment Scheme (China NEQAS) for HbA<sub>2</sub> and HbF testing, and to propose strategies for quality improvement.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 HbA<sub>2</sub>, 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: HbA<sub>2</sub> 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).</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":10390,\"journal\":{\"name\":\"Clinical chemistry and laboratory medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-09-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical chemistry and laboratory medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1515/cclm-2025-0683\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical chemistry and laboratory medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1515/cclm-2025-0683","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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.
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
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