Reliable quantification of fecal elastase-1: A study on sample stability, IDK ELISA and IDK Extract® device.

IF 2.9 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-07 DOI:10.1016/j.cca.2025.120541
Jenny K Kiviaho, Mikko Anttonen, Henrik Alfthan, Outi Itkonen
{"title":"Reliable quantification of fecal elastase-1: A study on sample stability, IDK ELISA and IDK Extract® device.","authors":"Jenny K Kiviaho, Mikko Anttonen, Henrik Alfthan, Outi Itkonen","doi":"10.1016/j.cca.2025.120541","DOIUrl":null,"url":null,"abstract":"<p><p>Quantitation of fecal elastase 1 (FE-1) is a non-invasive test for pancreatic function to detect moderate or severe exocrine insufficiency. The enzyme-linked immunosorbent assays (ELISA) are well-established tests for FE-1 detection. Traditional sample preparation by manual weighing and extraction is laborious, but new sample devices allow more effective sample preparation. FE-1 in stool has good stability but systematic studies on FE-1 stability in sampling and extraction devices are lacking. We examined the stability of FE-1 in the IDK Extract® device and intact stool samples at room temperature, 4 °C or -20 °C. Furthermore, we assessed the suitability of the IDK Extract® device for FE-1 testing and compared the performance of IDK FE-1 ELISA to that of the established ScheBo assay. FE-1 is stable in IDK Extract® device and intact stool for at least 29 days at all storage temperatures tested with deviation < 20 % from day zero concentration. When compared to weighing, the IDK Extract® device proved to be a reliable tool for sample preparation. Based on common clinical decision limits of pancreatic exocrine function, the ScheBo and IDK assays showed good agreement. In conclusion, IDK FE-1 assay together with the IDK Extract® device offers an effective and reliable method to determine exocrine pancreatic insufficiency. FE-1 is stable at various temperatures and the IDK and ScheBo assays perform equally. Thus, stool samples from outpatient clinics can be transported to the analytical laboratory cost-effectively at room temperature.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120541"},"PeriodicalIF":2.9000,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cca.2025.120541","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/7 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Quantitation of fecal elastase 1 (FE-1) is a non-invasive test for pancreatic function to detect moderate or severe exocrine insufficiency. The enzyme-linked immunosorbent assays (ELISA) are well-established tests for FE-1 detection. Traditional sample preparation by manual weighing and extraction is laborious, but new sample devices allow more effective sample preparation. FE-1 in stool has good stability but systematic studies on FE-1 stability in sampling and extraction devices are lacking. We examined the stability of FE-1 in the IDK Extract® device and intact stool samples at room temperature, 4 °C or -20 °C. Furthermore, we assessed the suitability of the IDK Extract® device for FE-1 testing and compared the performance of IDK FE-1 ELISA to that of the established ScheBo assay. FE-1 is stable in IDK Extract® device and intact stool for at least 29 days at all storage temperatures tested with deviation < 20 % from day zero concentration. When compared to weighing, the IDK Extract® device proved to be a reliable tool for sample preparation. Based on common clinical decision limits of pancreatic exocrine function, the ScheBo and IDK assays showed good agreement. In conclusion, IDK FE-1 assay together with the IDK Extract® device offers an effective and reliable method to determine exocrine pancreatic insufficiency. FE-1 is stable at various temperatures and the IDK and ScheBo assays perform equally. Thus, stool samples from outpatient clinics can be transported to the analytical laboratory cost-effectively at room temperature.

粪便弹性酶-1的可靠定量:样品稳定性、IDK ELISA和IDK Extract®装置的研究。
定量粪便弹性蛋白酶1 (FE-1)是胰腺功能的一种非侵入性测试,用于检测中度或重度外分泌功能不全。酶联免疫吸附试验(ELISA)是一种成熟的FE-1检测方法。传统的样品制备通过人工称重和提取是费力的,但新的样品设备允许更有效的样品制备。粪便中FE-1具有良好的稳定性,但对FE-1在采样和提取装置中的稳定性缺乏系统的研究。我们在室温、4 °C或-20 °C下检测了FE-1在IDK Extract®装置和完整粪便样品中的稳定性。此外,我们评估了IDK Extract®设备用于FE-1检测的适用性,并比较了IDK FE-1 ELISA与建立的ScheBo检测的性能。在IDK Extract®设备和完整的粪便中,FE-1在所有测试偏差的存储温度下至少稳定29 天
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Clinica Chimica Acta
Clinica Chimica Acta 医学-医学实验技术
CiteScore
10.10
自引率
2.00%
发文量
1268
审稿时长
23 days
期刊介绍: The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
×
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:604180095
Book学术官方微信