血清胆碱酯酶催化浓度的生物学变异

M. Altilia, F. Braga, Alessia Capoferri, M. Panteghini
{"title":"血清胆碱酯酶催化浓度的生物学变异","authors":"M. Altilia, F. Braga, Alessia Capoferri, M. Panteghini","doi":"10.1515/cclm-2022-0346","DOIUrl":null,"url":null,"abstract":"Measurements of serum cholinesterase (CHE, also called pseudocholinesterase) catalytic concentrations are primarily used as a test of liver function and, less frequently, as an indicator of possible organic phosphorous insecticide poisoning in agriculture or organic chemical industry workers [1]. Preoperative screening of CHE activity has been also advocated to identify individuals bearing genetic causes of enzyme deficiency in whom some muscle relaxant drugs, such as suxamethonium, administrated to aid in endotracheal intubation in surgery, may not be hydrolysed by CHE rapidly enough and cause apnea by a prolonged paralysis of respiratorymuscles [1]. Historically, many methods were proposed to measure CHE, using different acyl(thio)choline esters as substrates [2]. At present, however, all the most popular automated measuring systems use butyrylthiocholine for determining the CHE activity as this substrate provides the best reproducibility. To check the quality of CHEmeasurements it is essential to correctly define analytical performance specifications (APS). In 2014, the Strategic Conference organized by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) proposed models for establishing APS, recommending that the choice of the most appropriate model for a specific measurand should be based on its biological and clinical characteristics [3]. Allocation of CHE to the correctmodel to derive APS can be however not easy. Although this enzyme surely plays a role in monitoring the clinical conditions mentioned above, the measurand has not a defined role in the decision making of a specific disease and test results are not interpreted through established decision limits, so that outcome-based APS cannot be defined. On the other hand, its exact biological role is unknown, and this might be a limitation for applying the model based on biological variation (BV). As CHE demonstrated rather stable concentrations in healthy individuals, it appears however rational to use the BV model to derive APS [4]. This requires the availability of reliable BVdata. Unfortunately, all the available studies evaluating CHE BV suffered important limitations, among those the collection of serial samples in enrolled individuals at a variable time distance, the derivation of the within-subject BV (CVI) without subtracting analytical variation, the analysis of samples in different batches without considering the between-run analytical variation, or the wrong inclusion of the CHE seasonal variation in CVI estimate. Table 1 summarizes the drawbacks of each published study evaluated on the basis of the compliance with the EFLM critical appraisal checklist quality items (BIVAC-QI) [5]. Maybe for these major limitations, the EFLM BV database (https://biologicalvariation.eu/) does not include CHE in the list of evaluated measurands. Therefore, we decided to perform a study assessing BV components of CHE catalytic concentration by adopting an accurately designed experimental protocol in accordance with previous remmendations for the BV data production [6]. We employed frozen (−80 °C) serum samples from 35 apparently healthy Caucasian volunteers (13 men, 12 pre-, and 10 post-menopausal women; ages 19–62 years) obtained for a previous BV study [7]. CHE activity in serum is stable for several years if stored at temperature lower than −20 °C [1]. All sample donors were free of any evident disease, had no history of chronic disease, and did not receive any medication, including hormonal contraceptives if women, previously shown to decrease CHE [8, 9]. Other criteria for inclusion were that the subjects should be within 80–120% of ideal body weight and maintain their *Corresponding author: Federica Braga, UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157, Milan, Italy, Phone: +39 0239042743, Fax: +39 0250319835, E-mail: federica.braga@unimi.it. https://orcid.org/0000-00033562-7180 Mariangela Altilia, Alessia Capoferri andMauro Panteghini, Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Università Degli Studi di Milano, Milan, Italy Clin Chem Lab Med 2022; 60(8): e177–e180","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Biological variation of serum cholinesterase catalytic concentrations\",\"authors\":\"M. Altilia, F. Braga, Alessia Capoferri, M. Panteghini\",\"doi\":\"10.1515/cclm-2022-0346\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Measurements of serum cholinesterase (CHE, also called pseudocholinesterase) catalytic concentrations are primarily used as a test of liver function and, less frequently, as an indicator of possible organic phosphorous insecticide poisoning in agriculture or organic chemical industry workers [1]. Preoperative screening of CHE activity has been also advocated to identify individuals bearing genetic causes of enzyme deficiency in whom some muscle relaxant drugs, such as suxamethonium, administrated to aid in endotracheal intubation in surgery, may not be hydrolysed by CHE rapidly enough and cause apnea by a prolonged paralysis of respiratorymuscles [1]. Historically, many methods were proposed to measure CHE, using different acyl(thio)choline esters as substrates [2]. At present, however, all the most popular automated measuring systems use butyrylthiocholine for determining the CHE activity as this substrate provides the best reproducibility. To check the quality of CHEmeasurements it is essential to correctly define analytical performance specifications (APS). In 2014, the Strategic Conference organized by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) proposed models for establishing APS, recommending that the choice of the most appropriate model for a specific measurand should be based on its biological and clinical characteristics [3]. Allocation of CHE to the correctmodel to derive APS can be however not easy. Although this enzyme surely plays a role in monitoring the clinical conditions mentioned above, the measurand has not a defined role in the decision making of a specific disease and test results are not interpreted through established decision limits, so that outcome-based APS cannot be defined. On the other hand, its exact biological role is unknown, and this might be a limitation for applying the model based on biological variation (BV). As CHE demonstrated rather stable concentrations in healthy individuals, it appears however rational to use the BV model to derive APS [4]. This requires the availability of reliable BVdata. Unfortunately, all the available studies evaluating CHE BV suffered important limitations, among those the collection of serial samples in enrolled individuals at a variable time distance, the derivation of the within-subject BV (CVI) without subtracting analytical variation, the analysis of samples in different batches without considering the between-run analytical variation, or the wrong inclusion of the CHE seasonal variation in CVI estimate. Table 1 summarizes the drawbacks of each published study evaluated on the basis of the compliance with the EFLM critical appraisal checklist quality items (BIVAC-QI) [5]. Maybe for these major limitations, the EFLM BV database (https://biologicalvariation.eu/) does not include CHE in the list of evaluated measurands. Therefore, we decided to perform a study assessing BV components of CHE catalytic concentration by adopting an accurately designed experimental protocol in accordance with previous remmendations for the BV data production [6]. We employed frozen (−80 °C) serum samples from 35 apparently healthy Caucasian volunteers (13 men, 12 pre-, and 10 post-menopausal women; ages 19–62 years) obtained for a previous BV study [7]. CHE activity in serum is stable for several years if stored at temperature lower than −20 °C [1]. All sample donors were free of any evident disease, had no history of chronic disease, and did not receive any medication, including hormonal contraceptives if women, previously shown to decrease CHE [8, 9]. Other criteria for inclusion were that the subjects should be within 80–120% of ideal body weight and maintain their *Corresponding author: Federica Braga, UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157, Milan, Italy, Phone: +39 0239042743, Fax: +39 0250319835, E-mail: federica.braga@unimi.it. https://orcid.org/0000-00033562-7180 Mariangela Altilia, Alessia Capoferri andMauro Panteghini, Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Università Degli Studi di Milano, Milan, Italy Clin Chem Lab Med 2022; 60(8): e177–e180\",\"PeriodicalId\":10388,\"journal\":{\"name\":\"Clinical Chemistry and Laboratory Medicine (CCLM)\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-05-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Chemistry and Laboratory Medicine (CCLM)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1515/cclm-2022-0346\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Chemistry and Laboratory Medicine (CCLM)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1515/cclm-2022-0346","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1

摘要

血清胆碱酯酶(CHE,也称为假胆碱酯酶)催化浓度的测定主要用于肝功能测试,较少用作农业或有机化工工人可能有机磷杀虫剂中毒的指标[1]。术前筛查CHE活性也被提倡用于识别具有酶缺乏症遗传原因的个体,在这些个体中,一些肌肉松弛药物,如suxamethonium,在手术中用于辅助气管内插管,可能不能被CHE迅速水解,并通过长时间的呼吸肌肉麻痹引起呼吸暂停[1]。历史上,人们提出了许多方法来测量CHE,使用不同的酰基(硫)胆碱酯作为底物[2]。然而,目前,所有最流行的自动化测量系统都使用丁基硫代胆碱来测定CHE活性,因为这种底物提供了最好的重现性。为了检查化学测量的质量,必须正确定义分析性能规范(APS)。2014年,欧洲临床化学与检验医学联合会(European Federation of Clinical Chemistry and Laboratory Medicine, EFLM)组织的战略会议提出了建立APS的模型,建议根据具体措施的生物学和临床特点选择最合适的模型[3]。然而,将CHE分配到正确的模型以派生APS可能并不容易。虽然这种酶在上述临床情况的监测中确实发挥了作用,但该测量在特定疾病的决策中没有明确的作用,并且测试结果没有通过既定的决策限制来解释,因此无法定义基于结果的APS。另一方面,其确切的生物学作用尚不清楚,这可能是基于生物变异(BV)模型应用的局限性。由于CHE在健康个体中表现出相当稳定的浓度,因此使用BV模型推导APS似乎是合理的[4]。这需要可靠的bv数据的可用性。不幸的是,所有评估CHE BV的现有研究都存在重要的局限性,其中包括在可变时间距离上收集入组个体的系列样本,在不减去分析变异的情况下推导受试者内BV (CVI),在不考虑运行间分析变异的情况下分析不同批次的样本,或者在CVI估计中错误地包含CHE季节变化。表1总结了根据EFLM关键评估清单质量项目(BIVAC-QI)的依从性评估的每个已发表研究的缺陷[5]。也许是由于这些主要的限制,EFLM BV数据库(https://biologicalvariation.eu/)没有将CHE包括在评估指标列表中。因此,我们决定根据先前对BV数据生成的建议[6],采用精确设计的实验方案,进行一项评估CHE催化浓度的BV组分的研究。我们使用了35名明显健康的高加索志愿者(13名男性,12名绝经前和10名绝经后妇女)的冷冻(- 80°C)血清样本;年龄19-62岁),既往BV研究[7]。如果在低于- 20°C的温度下保存,血清中的CHE活性可稳定数年[1]。所有样本供者均无任何明显疾病,无慢性疾病史,未接受任何药物治疗,包括先前显示可降低CHE的女性激素避孕药[8,9]。其他纳入标准为受试者应在理想体重的80-120%以内,并保持其体重。通讯作者:Federica Braga, UOC Patologia Clinica,助理医生Fatebenefratelli-Sacco, Via GB Grassi 74, 20157,意大利米兰,电话:+39 0239042743,传真:+39 0250319835,E-mail: federica.braga@unimi.it。https://orcid.org/0000-00033562-7180 Mariangela Altilia, Alessia Capoferri和mauro Panteghini,检验医学计量溯源研究中心(CIRME),米兰Degli研究大学,米兰,意大利临床化学实验室医学2022;60 (8): e177-e180
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biological variation of serum cholinesterase catalytic concentrations
Measurements of serum cholinesterase (CHE, also called pseudocholinesterase) catalytic concentrations are primarily used as a test of liver function and, less frequently, as an indicator of possible organic phosphorous insecticide poisoning in agriculture or organic chemical industry workers [1]. Preoperative screening of CHE activity has been also advocated to identify individuals bearing genetic causes of enzyme deficiency in whom some muscle relaxant drugs, such as suxamethonium, administrated to aid in endotracheal intubation in surgery, may not be hydrolysed by CHE rapidly enough and cause apnea by a prolonged paralysis of respiratorymuscles [1]. Historically, many methods were proposed to measure CHE, using different acyl(thio)choline esters as substrates [2]. At present, however, all the most popular automated measuring systems use butyrylthiocholine for determining the CHE activity as this substrate provides the best reproducibility. To check the quality of CHEmeasurements it is essential to correctly define analytical performance specifications (APS). In 2014, the Strategic Conference organized by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) proposed models for establishing APS, recommending that the choice of the most appropriate model for a specific measurand should be based on its biological and clinical characteristics [3]. Allocation of CHE to the correctmodel to derive APS can be however not easy. Although this enzyme surely plays a role in monitoring the clinical conditions mentioned above, the measurand has not a defined role in the decision making of a specific disease and test results are not interpreted through established decision limits, so that outcome-based APS cannot be defined. On the other hand, its exact biological role is unknown, and this might be a limitation for applying the model based on biological variation (BV). As CHE demonstrated rather stable concentrations in healthy individuals, it appears however rational to use the BV model to derive APS [4]. This requires the availability of reliable BVdata. Unfortunately, all the available studies evaluating CHE BV suffered important limitations, among those the collection of serial samples in enrolled individuals at a variable time distance, the derivation of the within-subject BV (CVI) without subtracting analytical variation, the analysis of samples in different batches without considering the between-run analytical variation, or the wrong inclusion of the CHE seasonal variation in CVI estimate. Table 1 summarizes the drawbacks of each published study evaluated on the basis of the compliance with the EFLM critical appraisal checklist quality items (BIVAC-QI) [5]. Maybe for these major limitations, the EFLM BV database (https://biologicalvariation.eu/) does not include CHE in the list of evaluated measurands. Therefore, we decided to perform a study assessing BV components of CHE catalytic concentration by adopting an accurately designed experimental protocol in accordance with previous remmendations for the BV data production [6]. We employed frozen (−80 °C) serum samples from 35 apparently healthy Caucasian volunteers (13 men, 12 pre-, and 10 post-menopausal women; ages 19–62 years) obtained for a previous BV study [7]. CHE activity in serum is stable for several years if stored at temperature lower than −20 °C [1]. All sample donors were free of any evident disease, had no history of chronic disease, and did not receive any medication, including hormonal contraceptives if women, previously shown to decrease CHE [8, 9]. Other criteria for inclusion were that the subjects should be within 80–120% of ideal body weight and maintain their *Corresponding author: Federica Braga, UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157, Milan, Italy, Phone: +39 0239042743, Fax: +39 0250319835, E-mail: federica.braga@unimi.it. https://orcid.org/0000-00033562-7180 Mariangela Altilia, Alessia Capoferri andMauro Panteghini, Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Università Degli Studi di Milano, Milan, Italy Clin Chem Lab Med 2022; 60(8): e177–e180
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信