Ying Huang, Yan Zhang, Dahai He, Yehong Xie, Xiaohua Xu, Chaoqiong Zhou, Dian Yuan, Lirui Kong
{"title":"跨分析系统的甲状腺功能指标的实验室间参考变化值：比较分析","authors":"Ying Huang, Yan Zhang, Dahai He, Yehong Xie, Xiaohua Xu, Chaoqiong Zhou, Dian Yuan, Lirui Kong","doi":"10.1155/ijcp/6664598","DOIUrl":null,"url":null,"abstract":"<div>\n <p><b>Background:</b> The clinical application of reference change values (RCVs) is primarily used within the same laboratory analytical system, with limited research addressing its application across different analytical systems in various laboratories. The aim of this study is to estimate the analytical variation (CV<sub>A</sub>) and interlaboratory reference variation values (IL-RCV) using external quality assessment (EQA) data and biological variation data, to assess the interoperability of test results for thyroid function indicators across laboratories, and to provide reliable information for clinicians.</p>\n <p><b>Methods:</b> Data for thyroid function indicators, including thyroid-stimulating hormone (TSH), triiodothyronine (T<sub>3</sub>), thyroxine (T<sub>4</sub>), free T<sub>3</sub> (FT<sub>3</sub>), and free T<sub>4</sub> (FT<sub>4</sub>), were obtained from eight analytical systems participating in the first EQA conducted by the Clinical Laboratory Center of the National Health Commission in the United States in 2022. The average coefficient of variation (CV) from the five quality control materials was used to determine the CV<sub>A</sub> of each indicator across laboratories. Within-subject variation (CV<sub>I</sub>) and between-subject biological variation (CV<sub>G</sub>) data were obtained on the European Federation of clinical Chemistry and Laboratory Medicine (EFLM) biological variation website. IL-RCV values for each indicator with 95% (bilateral) probability were calculated using the log-normal method and the application of these values between laboratories was evaluated.</p>\n <p><b>Results:</b> The coefficients of CV<sub>A</sub> of thyroid function indicators differ across various analytical systems, with 27 individual items having a CV<sub>A</sub> greater than the Analyze Performance Specification target values (7%), and the overall range spanning from 3.08% to 11.85%. In addition to TSH and Abbott’s T<sub>3</sub>, the average CV<sub>A</sub> for all the tests exceeded the estimated data from the EFLM website. With 95% bilateral probability, the positive IL-RCV (IL-RCVpos) ranged from 17.7% to 68.4%, while the negative IL-RCV (IL-RCVneg) ranged from −15.0% to −40.6%, with the percentage of IL-RCVpos is higher than that of IL-RCVneg.</p>\n <p><b>Conclusions:</b> There are differences in the CV<sub>A</sub> of thyroid function indicators across different analytical systems, and the IL-RCV is not comparable. Clinicians should pay attention when interpreting reports and it is recommended to use analytical systems from the same manufacturer for the management and follow-up of patients with thyroid diseases.</p>\n </div>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2025 1","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/ijcp/6664598","citationCount":"0","resultStr":"{\"title\":\"Interlaboratory Reference Change Values for Thyroid Function Indicators Across Analytical Systems: A Comparative Analysis\",\"authors\":\"Ying Huang, Yan Zhang, Dahai He, Yehong Xie, Xiaohua Xu, Chaoqiong Zhou, Dian Yuan, Lirui Kong\",\"doi\":\"10.1155/ijcp/6664598\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n <p><b>Background:</b> The clinical application of reference change values (RCVs) is primarily used within the same laboratory analytical system, with limited research addressing its application across different analytical systems in various laboratories. The aim of this study is to estimate the analytical variation (CV<sub>A</sub>) and interlaboratory reference variation values (IL-RCV) using external quality assessment (EQA) data and biological variation data, to assess the interoperability of test results for thyroid function indicators across laboratories, and to provide reliable information for clinicians.</p>\\n <p><b>Methods:</b> Data for thyroid function indicators, including thyroid-stimulating hormone (TSH), triiodothyronine (T<sub>3</sub>), thyroxine (T<sub>4</sub>), free T<sub>3</sub> (FT<sub>3</sub>), and free T<sub>4</sub> (FT<sub>4</sub>), were obtained from eight analytical systems participating in the first EQA conducted by the Clinical Laboratory Center of the National Health Commission in the United States in 2022. The average coefficient of variation (CV) from the five quality control materials was used to determine the CV<sub>A</sub> of each indicator across laboratories. Within-subject variation (CV<sub>I</sub>) and between-subject biological variation (CV<sub>G</sub>) data were obtained on the European Federation of clinical Chemistry and Laboratory Medicine (EFLM) biological variation website. IL-RCV values for each indicator with 95% (bilateral) probability were calculated using the log-normal method and the application of these values between laboratories was evaluated.</p>\\n <p><b>Results:</b> The coefficients of CV<sub>A</sub> of thyroid function indicators differ across various analytical systems, with 27 individual items having a CV<sub>A</sub> greater than the Analyze Performance Specification target values (7%), and the overall range spanning from 3.08% to 11.85%. In addition to TSH and Abbott’s T<sub>3</sub>, the average CV<sub>A</sub> for all the tests exceeded the estimated data from the EFLM website. With 95% bilateral probability, the positive IL-RCV (IL-RCVpos) ranged from 17.7% to 68.4%, while the negative IL-RCV (IL-RCVneg) ranged from −15.0% to −40.6%, with the percentage of IL-RCVpos is higher than that of IL-RCVneg.</p>\\n <p><b>Conclusions:</b> There are differences in the CV<sub>A</sub> of thyroid function indicators across different analytical systems, and the IL-RCV is not comparable. Clinicians should pay attention when interpreting reports and it is recommended to use analytical systems from the same manufacturer for the management and follow-up of patients with thyroid diseases.</p>\\n </div>\",\"PeriodicalId\":13782,\"journal\":{\"name\":\"International Journal of Clinical Practice\",\"volume\":\"2025 1\",\"pages\":\"\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-06-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1155/ijcp/6664598\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1155/ijcp/6664598\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Practice","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1155/ijcp/6664598","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Interlaboratory Reference Change Values for Thyroid Function Indicators Across Analytical Systems: A Comparative Analysis
Background: The clinical application of reference change values (RCVs) is primarily used within the same laboratory analytical system, with limited research addressing its application across different analytical systems in various laboratories. The aim of this study is to estimate the analytical variation (CVA) and interlaboratory reference variation values (IL-RCV) using external quality assessment (EQA) data and biological variation data, to assess the interoperability of test results for thyroid function indicators across laboratories, and to provide reliable information for clinicians.
Methods: Data for thyroid function indicators, including thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), free T3 (FT3), and free T4 (FT4), were obtained from eight analytical systems participating in the first EQA conducted by the Clinical Laboratory Center of the National Health Commission in the United States in 2022. The average coefficient of variation (CV) from the five quality control materials was used to determine the CVA of each indicator across laboratories. Within-subject variation (CVI) and between-subject biological variation (CVG) data were obtained on the European Federation of clinical Chemistry and Laboratory Medicine (EFLM) biological variation website. IL-RCV values for each indicator with 95% (bilateral) probability were calculated using the log-normal method and the application of these values between laboratories was evaluated.
Results: The coefficients of CVA of thyroid function indicators differ across various analytical systems, with 27 individual items having a CVA greater than the Analyze Performance Specification target values (7%), and the overall range spanning from 3.08% to 11.85%. In addition to TSH and Abbott’s T3, the average CVA for all the tests exceeded the estimated data from the EFLM website. With 95% bilateral probability, the positive IL-RCV (IL-RCVpos) ranged from 17.7% to 68.4%, while the negative IL-RCV (IL-RCVneg) ranged from −15.0% to −40.6%, with the percentage of IL-RCVpos is higher than that of IL-RCVneg.
Conclusions: There are differences in the CVA of thyroid function indicators across different analytical systems, and the IL-RCV is not comparable. Clinicians should pay attention when interpreting reports and it is recommended to use analytical systems from the same manufacturer for the management and follow-up of patients with thyroid diseases.
期刊介绍：
IJCP is a general medical journal. IJCP gives special priority to work that has international appeal.
IJCP publishes:
Editorials. IJCP Editorials are commissioned. [Peer reviewed at the editor''s discretion]
Perspectives. Most IJCP Perspectives are commissioned. Example. [Peer reviewed at the editor''s discretion]
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Original data from clinical investigations. In particular: Primary research papers from RCTs, observational studies, epidemiological studies; pre-specified sub-analyses; pooled analyses. [Always peer reviewed]
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Letters. [Peer reviewed at the editor''s discretion]
International scope
IJCP publishes work from investigators globally. Around 30% of IJCP articles list an author from the UK. Around 30% of IJCP articles list an author from the USA or Canada. Around 45% of IJCP articles list an author from a European country that is not the UK. Around 15% of articles published in IJCP list an author from a country in the Asia-Pacific region.
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