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自动化血库系统 IH-500 与手动试管法在抗血型抗体效价滴定中的比较:一种定量方法。

A comparison of the automated blood bank system IH-500 and manual tube method for anti-blood group antibody titration: a quantitative approach.

机构信息

Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, South Korea.

Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Seoul, South Korea.

出版信息

Transfus Apher Sci. 2020 Aug;59(4):102806. doi: 10.1016/j.transci.2020.102806. Epub 2020 May 17.

DOI:10.1016/j.transci.2020.102806
PMID:32446633
Abstract

BACKGROUND

Anti-blood group antibody titers (ABTs) reported in titer values are variable depending on the testing method used. The introduction of new test methods such as automated methods requires proper method comparison. In this study, the automated blood bank system and manual tube method for ABT were compared using a log-transformed dataset to evaluate the alternative statistical approach.

METHODS

ABT was conducted using specimens referred for solid organ transplantation. Methods for comparison were conventional manual tube method and IH-500 automated blood bank system using column agglutination (CAT). Criteria for agreement were exact match and 1-titer match. Measured titer values were log-transformed into interval scale for Deming regression analysis.

RESULTS

From the comparison of the tube and CAT methods using titer values and the two criteria, the exact and 1-titer match were 15.9-41.5 % and 65.9-97.6 %, respectively. Deming regression was used to demonstrate the presence of both proportional and constant difference between the two methods.

CONCLUSION

The method comparison using conventional statistical approaches had limits due to the semi-quantitative value of the test. Log-transformed interval scale values for comparison were useful for interpretation of method comparison datasets. This alternative statistical approach could contribute to a more accurate comparison between assays and standardization of ABT testing.

摘要

背景

抗血型抗体效价(ABTs)以效价值报告,其值因所用检测方法而异。新的检测方法(如自动化方法)的引入需要进行适当的方法比较。在这项研究中,使用对数转换数据集比较了自动化血型库系统和手动试管法的 ABT,以评估替代的统计方法。

方法

使用因实体器官移植而转介的标本进行 ABT。比较的方法是传统的手动试管法和使用柱状凝聚(CAT)的 IH-500 自动化血库系统。一致性的标准是完全匹配和 1 倍匹配。测量的效价值被对数转换为区间尺度,用于 Deming 回归分析。

结果

从试管法和 CAT 方法的效价值和两个标准的比较来看,完全匹配和 1 倍匹配分别为 15.9-41.5%和 65.9-97.6%。Deming 回归用于证明两种方法之间存在比例和常数差异。

结论

由于测试的半定量值,使用传统统计方法进行方法比较存在局限性。比较用的对数转换区间尺度值有助于解释方法比较数据集。这种替代的统计方法可以为更准确的检测比较和 ABT 检测的标准化做出贡献。

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引用本文的文献

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ABO antibody titres: a multisite comparative study of equivalency and reproducibility for automated solid-phase and haemagglutination titration, and manual dilution with gel column agglutination technology.ABO 抗体效价:自动化固相和血凝滴定与凝胶柱凝集技术的手动稀释比较的多中心研究,评估其等效性和可重复性。
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