Evaluación analítica del inmunoanálisis Lumipulse® G BRAHMS PCT para la medida de procalcitonina

Luis García de Guadiana Romualdo , Verónica Ramos Arenas , Concepción Campillo Martín , María Isabel García Sánchez , Juan Antonio Vílchez Aguilera , María Dolores Albaladejo Otón
{"title":"Evaluación analítica del inmunoanálisis Lumipulse® G BRAHMS PCT para la medida de procalcitonina","authors":"Luis García de Guadiana Romualdo ,&nbsp;Verónica Ramos Arenas ,&nbsp;Concepción Campillo Martín ,&nbsp;María Isabel García Sánchez ,&nbsp;Juan Antonio Vílchez Aguilera ,&nbsp;María Dolores Albaladejo Otón","doi":"10.1016/j.labcli.2018.02.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Procalcitonin (PCT) is a useful biomarker for the management of patients with severe bacterial infection and sepsis. Different types of assays are currently available for its measurement. This study presents an evaluation of the analytical performance of the novel Lumipulse G BRAHMS PCT™ immunoassay on the Lumipulse 600II analyser.</p></div><div><h3>Material and methods</h3><p>This analytical evaluation included the calculation of the limit of blank, limit of detection, functional sensitivity, intra-assay and total imprecision, confirmation of linearity and the comparison with the ELECSYS BRAHMS PCT™ assay.</p></div><div><h3>Results</h3><p>Limit of blank, limit of detection and functional sensitivity were 0.0011 ng/mL, 0.0025 ng/mL, and 0.008 ng/mL, respectively. Intra-assay and total imprecision ranged from 0.78 to 2.16 and from 1.31 to 2.06, respectively, when control levels were used. The linearity was excellent (r=0.999) in the range of concentrations established by manufacturer. A highly significant agreement was found in the comparison between both assays (Lumipulse BRAHMS PCT = −0.016 + 1.006 * ELECSYS BRAHMS PCT). The mean bias was 0.2 ng/mL (95% CI: −0.906 to 0.430). When PCT levels were stratified according to the ranges normally used for their clinical interpretation, the agreement was very high (kappa index: 0.9874 (95% CI: 0.9696 to 1.0000).</p></div><div><h3>Conclusion</h3><p>The novel assay Lumipulse BRAHMS PCT, with CLEIA technology, appears to be acceptable for clinical use.</p></div>","PeriodicalId":101105,"journal":{"name":"Revista del Laboratorio Clínico","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.labcli.2018.02.001","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista del Laboratorio Clínico","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1888400818300084","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction

Procalcitonin (PCT) is a useful biomarker for the management of patients with severe bacterial infection and sepsis. Different types of assays are currently available for its measurement. This study presents an evaluation of the analytical performance of the novel Lumipulse G BRAHMS PCT™ immunoassay on the Lumipulse 600II analyser.

Material and methods

This analytical evaluation included the calculation of the limit of blank, limit of detection, functional sensitivity, intra-assay and total imprecision, confirmation of linearity and the comparison with the ELECSYS BRAHMS PCT™ assay.

Results

Limit of blank, limit of detection and functional sensitivity were 0.0011 ng/mL, 0.0025 ng/mL, and 0.008 ng/mL, respectively. Intra-assay and total imprecision ranged from 0.78 to 2.16 and from 1.31 to 2.06, respectively, when control levels were used. The linearity was excellent (r=0.999) in the range of concentrations established by manufacturer. A highly significant agreement was found in the comparison between both assays (Lumipulse BRAHMS PCT = −0.016 + 1.006 * ELECSYS BRAHMS PCT). The mean bias was 0.2 ng/mL (95% CI: −0.906 to 0.430). When PCT levels were stratified according to the ranges normally used for their clinical interpretation, the agreement was very high (kappa index: 0.9874 (95% CI: 0.9696 to 1.0000).

Conclusion

The novel assay Lumipulse BRAHMS PCT, with CLEIA technology, appears to be acceptable for clinical use.

Lumipulse®G BRAHMS PCT免疫分析测定降钙素原的分析评价
降钙素原(PCT)是治疗严重细菌感染和脓毒症患者的有用生物标志物。目前有不同类型的测定方法可用于其测量。本研究对新型Lumipulse G BRAHMS PCT™免疫分析在Lumipulse 600II分析仪上的分析性能进行了评估。材料和方法本分析评价包括空白限、检测限、功能灵敏度、测定内和总不精密度的计算、线性确认以及与ELECSYS BRAHMS PCT™测定法的比较。结果空白限为0.0011 ng/mL,检测限为0.0025 ng/mL,功能灵敏度为0.008 ng/mL。当使用对照水平时,测定内不精密度和总不精密度分别为0.78 ~ 2.16和1.31 ~ 2.06。在生产厂家规定的浓度范围内,线性良好(r=0.999)。在两种检测方法的比较中发现了高度显著的一致性(Lumipulse BRAHMS PCT = - 0.016 + 1.006 * ELECSYS BRAHMS PCT)。平均偏倚为0.2 ng/mL (95% CI: - 0.906 ~ 0.430)。当PCT水平根据通常用于临床解释的范围进行分层时,一致性非常高(kappa指数:0.9874 (95% CI: 0.9696至1.0000)。结论采用CLEIA技术的Lumipulse BRAHMS PCT检测方法可用于临床。
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
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