Coefficients of variation analyses of internal quality control status for blood lead in China from 2015 to 2023.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2024-11-18 DOI:10.1177/00045632241297885

Han Ma, Wei Wang, Na Dong, Jiali Liu, Shuai Yuan, Chuanbao Zhang, Chao Zhang, Jie Zeng, Ying Yan, Zhiguo Wang

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引用次数: 0

Abstract

Background: Blood lead test is widely conducted in Chinese laboratories, while the imprecision of blood lead measurement based on internal quality control (IQC) across China has not been comprehensively evaluated nowadays.

Methods: Using the IQC data of blood lead collected through a web-based external quality assessment (EQA) reporting system, we analysed current coefficients of variation (CVs) of blood lead from 2015 to 2023 among Chinese laboratories. Two allowable total error (TEa) imprecision levels from EQA were applied to calculate the pass rates, namely percentages of laboratories meeting precision quality specifications. Besides, CV values and pass rates by different subgroups were further performed to assess potential differences.

Results: Generally, median CV values significantly declined year by year from 6.8% in February 2015 to 5.9% in March 2023. The pass rates based on 1/3 TEa showed upward trends increasing from 15.3% in February 2015 to 20.0% in March 2023, but these percentages were non-ideal with less than 25%. No significant differences in CVs were found between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories. Significant time trends were observed in tertiary hospitals and non-accredited laboratories. As for manufacturers, Bohui and self-made QC sample were most widely used with obvious interannual declining trends of CVs.

Conclusions: The CVs of blood lead demonstrated continuous overall improvements in the past twenty years. However, relatively lower pass rates indicated the non-ideal imprecision performance, and more proper performance specifications are warranted. Thus, imprecision improvement and ongoing investigation for blood lead IQC are still needed.

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2015-2023年中国血铅内部质量控制状况的变异系数分析。

背景：血铅检测在中国实验室广泛开展，而基于内部质量控制（IQC）的血铅测量在中国的不精确性尚未得到全面评估：血铅检测在中国实验室中广泛开展，而基于内部质量控制（IQC）的血铅测量在中国各地的不精确性尚未得到全面评估：方法：通过基于网络的外部质量评估（EQA）报告系统收集的血铅IQC数据，我们分析了目前中国实验室从2015年至2023年的血铅变异系数（CVs）。应用 EQA 的两个允许总误差（TEa）不精密度水平计算合格率，即符合精密度质量规范的实验室百分比。此外，还进一步对不同分组的CV值和合格率进行了分析，以评估潜在的差异：总体而言，中位 CV 值逐年明显下降，从 2015 年 2 月的 6.8% 降至 2023 年 3 月的 5.9%。基于 1/3 TEa 的合格率呈上升趋势，从 2015 年 2 月的 15.3% 上升至 2023 年 3 月的 20.0%，但这些百分比都不理想，低于 25%。三甲医院与非三甲医院之间以及通过评审的实验室与未通过评审的实验室之间的 CV 值无明显差异。在三级医院和非认证实验室中观察到了明显的时间趋势。在生产厂家方面，博汇和自制质控样本的使用最为广泛，CVs呈明显的年际下降趋势：结论：近二十年来，血铅的 CV 值总体上持续改善。结论：在过去的二十年中，血铅的 CV 值总体上持续改善，但相对较低的合格率表明其不精密度表现并不理想，因此有必要制定更合理的性能指标。因此，仍需对血铅 IQC 的不精确度进行改进和持续调查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).