输血医学中的抗体滴度:对检测准确性、可靠性和临床应用的关键性重新评估。

IF 3.7 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Matthew S Karafin, Robert A DeSimone, James Dvorak, Ryan A Metcalf, Monica B Pagano, Yara A Park, Joseph Schwartz, Rhona J Souers, Zbigniew M Szczepiorkowski, Lynne Uhl, Glenn Ramsey
{"title":"输血医学中的抗体滴度:对检测准确性、可靠性和临床应用的关键性重新评估。","authors":"Matthew S Karafin, Robert A DeSimone, James Dvorak, Ryan A Metcalf, Monica B Pagano, Yara A Park, Joseph Schwartz, Rhona J Souers, Zbigniew M Szczepiorkowski, Lynne Uhl, Glenn Ramsey","doi":"10.5858/arpa.2022-0248-CP","DOIUrl":null,"url":null,"abstract":"<p><strong>Context.—: </strong>Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008.</p><p><strong>Objective.—: </strong>To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing.</p><p><strong>Design.—: </strong>Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice.</p><p><strong>Results.—: </strong>A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less.</p><p><strong>Conclusions.—: </strong>Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making.</p>","PeriodicalId":8305,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Antibody Titers in Transfusion Medicine: A Critical Reevaluation of Testing Accuracy, Reliability, and Clinical Use.\",\"authors\":\"Matthew S Karafin, Robert A DeSimone, James Dvorak, Ryan A Metcalf, Monica B Pagano, Yara A Park, Joseph Schwartz, Rhona J Souers, Zbigniew M Szczepiorkowski, Lynne Uhl, Glenn Ramsey\",\"doi\":\"10.5858/arpa.2022-0248-CP\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context.—: </strong>Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008.</p><p><strong>Objective.—: </strong>To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing.</p><p><strong>Design.—: </strong>Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice.</p><p><strong>Results.—: </strong>A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less.</p><p><strong>Conclusions.—: </strong>Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making.</p>\",\"PeriodicalId\":8305,\"journal\":{\"name\":\"Archives of pathology & laboratory medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2023-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of pathology & laboratory medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.5858/arpa.2022-0248-CP\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of pathology & laboratory medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5858/arpa.2022-0248-CP","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

上下文。-:自2008年统一程序的开发和引入以来,已经确定了不同抗体滴定方法之间的实质性差异。-:确定使用熟练度测试测量的最新方法或技术是否减少了实验室间和实验室内的差异。-: 2014年至2018年抗体滴定能力测试数据来自美国病理学家学会。通过按方法和相分析滴度结果的分布,将结果与供应商的质量控制滴度进行比较,并通过评估每个实验室两次收到相同滴度的样品时成对滴度结果的分布,比较实验室间和实验室内的差异。-:研究期间共有1337个实验室参与了抗体效价熟练度测试。只有54.1%(10852例中5874例)的抗d和63.4%(5680例中3603例)的抗a报告反应与供应商预期结果在1滴以内。对同一方法实验室间一致性的审查发现,抗a抗体的78.4%(4004例中的3139例)和抗d抗体的89.0%(10852例中的9655例)的实验室反应低于模式反应的1滴度。当提供2个相同滴度(抗- d滴度:16)的连续样品时,使用统一方法的实验室中有85%(434个实验室中有367个)和使用其他方法的实验室中有80%(576个实验室中有458个)报告的滴度差异为1或更小。-:尽管取得了进展,但与临床实践中对滴度结果的强烈依赖相比,该检测的实验室间和实验室内差异仍然很高。有必要重新评估该测试在临床决策中的作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Antibody Titers in Transfusion Medicine: A Critical Reevaluation of Testing Accuracy, Reliability, and Clinical Use.

Context.—: Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008.

Objective.—: To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing.

Design.—: Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice.

Results.—: A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less.

Conclusions.—: Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making.

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
CiteScore
9.20
自引率
2.20%
发文量
369
审稿时长
3-8 weeks
期刊介绍: Welcome to the website of the Archives of Pathology & Laboratory Medicine (APLM). This monthly, peer-reviewed journal of the College of American Pathologists offers global reach and highest measured readership among pathology journals. Published since 1926, ARCHIVES was voted in 2009 the only pathology journal among the top 100 most influential journals of the past 100 years by the BioMedical and Life Sciences Division of the Special Libraries Association. Online access to the full-text and PDF files of APLM articles is free.
×
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