实验室内相同仪器间的偏差是否会影响绝对高敏感肌钙蛋白δ在第99百分位上限附近的解释?

Q3 Medicine
E. Stenner, R. Russo, M. Ruscio, G. Barbati, A. Aleksova
{"title":"实验室内相同仪器间的偏差是否会影响绝对高敏感肌钙蛋白δ在第99百分位上限附近的解释?","authors":"E. Stenner, R. Russo, M. Ruscio, G. Barbati, A. Aleksova","doi":"10.36648/2472-1646.5.1.56","DOIUrl":null,"url":null,"abstract":"Aim of the study: To measure high-sensitive troponin (Access hsTnI) interidentical- instrument bias (DxI800 Beckman Coulter) in order to understand if it can compromise the interpretation of absolute delta value for rapid algorithms 0/1-0/3 hours. Materials and methods: One hundred fifty-nine lithium/heparin plasma samples were processed sequentially on three DxI800 (DxI1, DxI2, DxI3). The results given by the three instruments were analyzed as followed: DxI1 vs. DxI2, DxI1 vs. DxI3, DxI2 vs. DxI3. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen’s Kappa statistic. Results: PB regression did not show any significant deviation from linearity and no proportional nor constant differences were observed among instruments. Moreover, the mean absolute bias, even though among the three instruments the lowest 95%CI lower limit was -3.75 and the highest 95%CI upper limit was 3.92 ng/L, was within the acceptance limits (all results<reference change value). The concordance between each couple of instruments was mostly strong. Conclusion: Our data suggest that inter-identical-instrument bias needs to be considered before evaluating the clinical diagnostic accuracy of one absolute delta with respect to another, in order to define the minimum absolute delta that the laboratory can guarantee to the clinicians.","PeriodicalId":39398,"journal":{"name":"Open Biomarkers Journal","volume":"20 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?\",\"authors\":\"E. Stenner, R. Russo, M. Ruscio, G. Barbati, A. Aleksova\",\"doi\":\"10.36648/2472-1646.5.1.56\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Aim of the study: To measure high-sensitive troponin (Access hsTnI) interidentical- instrument bias (DxI800 Beckman Coulter) in order to understand if it can compromise the interpretation of absolute delta value for rapid algorithms 0/1-0/3 hours. Materials and methods: One hundred fifty-nine lithium/heparin plasma samples were processed sequentially on three DxI800 (DxI1, DxI2, DxI3). The results given by the three instruments were analyzed as followed: DxI1 vs. DxI2, DxI1 vs. DxI3, DxI2 vs. DxI3. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen’s Kappa statistic. Results: PB regression did not show any significant deviation from linearity and no proportional nor constant differences were observed among instruments. Moreover, the mean absolute bias, even though among the three instruments the lowest 95%CI lower limit was -3.75 and the highest 95%CI upper limit was 3.92 ng/L, was within the acceptance limits (all results<reference change value). The concordance between each couple of instruments was mostly strong. Conclusion: Our data suggest that inter-identical-instrument bias needs to be considered before evaluating the clinical diagnostic accuracy of one absolute delta with respect to another, in order to define the minimum absolute delta that the laboratory can guarantee to the clinicians.\",\"PeriodicalId\":39398,\"journal\":{\"name\":\"Open Biomarkers Journal\",\"volume\":\"20 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Open Biomarkers Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.36648/2472-1646.5.1.56\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Open Biomarkers Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.36648/2472-1646.5.1.56","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 1

摘要

研究目的:测量高灵敏度肌钙蛋白(Access hsTnI)同质仪器偏差(DxI800 Beckman Coulter),以了解它是否会影响快速算法0/1-0/3小时的绝对delta值的解释。材料与方法:在3台DxI800 (DxI1、DxI2、DxI3)上依次处理159份锂/肝素血浆样品。三种仪器给出的结果分析如下:DxI1与DxI2, DxI1与DxI3, DxI2与DxI3。统计分析采用Passing-Bablok回归、Bland-Altman检验和Cohen’s Kappa统计。结果:PB回归与线性关系无显著偏差,各仪器间无成比例或恒定差异。此外,尽管三种仪器的95%CI下限为-3.75,95%CI上限为3.92 ng/L,但平均绝对偏差仍在可接受范围内(所有结果均<参考变化值)。每一对乐器之间的一致性大多很强。结论:我们的数据表明,在评估一个绝对增量相对于另一个绝对增量的临床诊断准确性之前,需要考虑相同仪器间的偏差,以便确定实验室可以向临床医生保证的最小绝对增量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?
Aim of the study: To measure high-sensitive troponin (Access hsTnI) interidentical- instrument bias (DxI800 Beckman Coulter) in order to understand if it can compromise the interpretation of absolute delta value for rapid algorithms 0/1-0/3 hours. Materials and methods: One hundred fifty-nine lithium/heparin plasma samples were processed sequentially on three DxI800 (DxI1, DxI2, DxI3). The results given by the three instruments were analyzed as followed: DxI1 vs. DxI2, DxI1 vs. DxI3, DxI2 vs. DxI3. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen’s Kappa statistic. Results: PB regression did not show any significant deviation from linearity and no proportional nor constant differences were observed among instruments. Moreover, the mean absolute bias, even though among the three instruments the lowest 95%CI lower limit was -3.75 and the highest 95%CI upper limit was 3.92 ng/L, was within the acceptance limits (all results
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
Open Biomarkers Journal
Open Biomarkers Journal Medicine-Medicine (miscellaneous)
CiteScore
0.80
自引率
0.00%
发文量
9
期刊介绍: The Open Biomarkers Journal is an Open Access online journal, which publishes original full-length, short research articles and reviews on biomarkers in clinical, medical and pharmaceutical research. The coverage includes biomarkers of disease, new biomarkers, exposure to drugs, genetic effects, and applications of biomarkers. The Open Biomarkers Journal, a peer reviewed journal, aims to provide the most complete and reliable source of information on current developments in the field. The emphasis will be on publishing quality articles rapidly and freely available to researchers worldwide.
×
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
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