T50钙蛋白结晶试验的验证:偏差估计和干扰。

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Joyce Y Xu, Didier Falconnet, Tarah van den Berkmortel, Sandra de la Rosa, Vincent Linder, Robert de Jonge, Andreas Pasch, Marc G Vervloet, Henrike M Hamer
{"title":"T50钙蛋白结晶试验的验证:偏差估计和干扰。","authors":"Joyce Y Xu, Didier Falconnet, Tarah van den Berkmortel, Sandra de la Rosa, Vincent Linder, Robert de Jonge, Andreas Pasch, Marc G Vervloet, Henrike M Hamer","doi":"10.1515/cclm-2025-0600","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based <i>in vitro</i> diagnostic assay that determines the calciprotein crystallization time in patients. It is based on the one-half maximum transition time of calciprotein particle 1 (CPP1) to calciprotein particle 2 (CPP2) in serum, as detected by nephelometry. To date, the T50 test has only been performed at Calciscon AG, where the assay has been developed and is manufactured. The aim of this study was to compare the agreement and precision of the T50 test in a routine clinical laboratory. Additionally, the interference of free hemoglobin, bilirubin, lipid and low molecular weight heparin (LMWH) was analyzed in the T50 test.</p><p><strong>Methods: </strong>Serum samples were measured at both laboratory sites to determine the agreement. The CLSI EP15-A3 protocol was used to evaluate the precision. Interference was analyzed by spiking pooled serum samples with interfering analytes.</p><p><strong>Results: </strong>Both laboratories showed excellent agreement in the T50 values (y=1.002x-4). Furthermore, high precision was observed for the clinically relevant lower range of T50 with a total variation coefficient of 6.4 %. Serum samples with mid and higher ranges of T50 failed the CLSI precision criteria with a total variance of 10.1 % and 6.2 %, respectively. Lastly, no interferences were observed within the normally observed clinical serum concentrations of free hemoglobin, bilirubin, lipid, and LMWH.</p><p><strong>Conclusions: </strong>The T50 test was successfully implemented in a routine laboratory setting. Additionally, the precision and interference observed in this study largely agreed with the manufacturer's claims.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Verification of the T50 Calciprotein Crystallization test: bias estimation and interferences.\",\"authors\":\"Joyce Y Xu, Didier Falconnet, Tarah van den Berkmortel, Sandra de la Rosa, Vincent Linder, Robert de Jonge, Andreas Pasch, Marc G Vervloet, Henrike M Hamer\",\"doi\":\"10.1515/cclm-2025-0600\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based <i>in vitro</i> diagnostic assay that determines the calciprotein crystallization time in patients. It is based on the one-half maximum transition time of calciprotein particle 1 (CPP1) to calciprotein particle 2 (CPP2) in serum, as detected by nephelometry. To date, the T50 test has only been performed at Calciscon AG, where the assay has been developed and is manufactured. The aim of this study was to compare the agreement and precision of the T50 test in a routine clinical laboratory. Additionally, the interference of free hemoglobin, bilirubin, lipid and low molecular weight heparin (LMWH) was analyzed in the T50 test.</p><p><strong>Methods: </strong>Serum samples were measured at both laboratory sites to determine the agreement. The CLSI EP15-A3 protocol was used to evaluate the precision. Interference was analyzed by spiking pooled serum samples with interfering analytes.</p><p><strong>Results: </strong>Both laboratories showed excellent agreement in the T50 values (y=1.002x-4). Furthermore, high precision was observed for the clinically relevant lower range of T50 with a total variation coefficient of 6.4 %. Serum samples with mid and higher ranges of T50 failed the CLSI precision criteria with a total variance of 10.1 % and 6.2 %, respectively. Lastly, no interferences were observed within the normally observed clinical serum concentrations of free hemoglobin, bilirubin, lipid, and LMWH.</p><p><strong>Conclusions: </strong>The T50 test was successfully implemented in a routine laboratory setting. Additionally, the precision and interference observed in this study largely agreed with the manufacturer's claims.</p>\",\"PeriodicalId\":10390,\"journal\":{\"name\":\"Clinical chemistry and laboratory medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-20\",\"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-2025-0600\",\"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-2025-0600","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:T50钙蛋白结晶试验(T50试验)是一种新的基于血液的体外诊断方法,可测定患者的钙蛋白结晶时间。它是基于血清中钙蛋白颗粒1 (CPP1)到钙蛋白颗粒2 (CPP2)的最大过渡时间的一半,通过比浊法检测。迄今为止,T50测试仅在Calciscon AG公司进行,该检测是在那里开发和制造的。本研究的目的是比较常规临床实验室T50检测的一致性和准确性。分析游离血红蛋白、胆红素、脂质、低分子肝素(LMWH)对T50试验的干扰。方法:测定两个实验室的血清样本,以确定两者的一致性。采用CLSI EP15-A3方案进行精密度评价。干扰分析方法是用干扰分析物对混合血清样品进行尖峰处理。结果:两个实验室在T50值上有很好的一致性(y=1.002x-4)。此外,T50的临床相关下限精度较高,总变异系数为6.4 %。T50中高范围的血清样品不符合CLSI精度标准,总方差分别为10.1%和6. %。最后,在正常观察的临床血清游离血红蛋白、胆红素、脂质和低分子肝素浓度中未观察到干扰。结论:T50测试在常规实验室环境中成功实施。此外,在本研究中观察到的精度和干扰在很大程度上与制造商的说法一致。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Verification of the T50 Calciprotein Crystallization test: bias estimation and interferences.

Objectives: The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based in vitro diagnostic assay that determines the calciprotein crystallization time in patients. It is based on the one-half maximum transition time of calciprotein particle 1 (CPP1) to calciprotein particle 2 (CPP2) in serum, as detected by nephelometry. To date, the T50 test has only been performed at Calciscon AG, where the assay has been developed and is manufactured. The aim of this study was to compare the agreement and precision of the T50 test in a routine clinical laboratory. Additionally, the interference of free hemoglobin, bilirubin, lipid and low molecular weight heparin (LMWH) was analyzed in the T50 test.

Methods: Serum samples were measured at both laboratory sites to determine the agreement. The CLSI EP15-A3 protocol was used to evaluate the precision. Interference was analyzed by spiking pooled serum samples with interfering analytes.

Results: Both laboratories showed excellent agreement in the T50 values (y=1.002x-4). Furthermore, high precision was observed for the clinically relevant lower range of T50 with a total variation coefficient of 6.4 %. Serum samples with mid and higher ranges of T50 failed the CLSI precision criteria with a total variance of 10.1 % and 6.2 %, respectively. Lastly, no interferences were observed within the normally observed clinical serum concentrations of free hemoglobin, bilirubin, lipid, and LMWH.

Conclusions: The T50 test was successfully implemented in a routine laboratory setting. Additionally, the precision and interference observed in this study largely agreed with the manufacturer's claims.

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
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
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 Follow @cclm_degruyter on Twitter!
×
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