评价一种新的快速抗 HbF-FITC 检测试剂盒 Trillium QuikQuant 用于检测和定量胎儿-母体出血。

Evaluation of a new rapid anti-HbF FITC assay, Trillium QuikQuant, for detection and quantitation of foetomaternal haemorrhage.

机构信息

Haematology Department, PathWest Laboratory Medicine WA, Perth, WA, Australia.

出版信息

Int J Lab Hematol. 2013 Feb;35(1):106-10. doi: 10.1111/j.1751-553X.2012.01463.x. Epub 2012 Aug 14.

DOI:10.1111/j.1751-553X.2012.01463.x

PMID:22889294

Abstract

INTRODUCTION

This study evaluated a new product for flow cytometric foetomaternal haemorrhage (FMH) quantitation, Trillium QuikQuant anti-HbF FITC kit (Trillium Diagnostics, USA), in comparison with the Millipore anti-HbF FITC method.

METHODS

Blood from 67 antenatal or postpartum RhD-negative women together with 108 samples spiked with 0.2%, 0.4%, 0.6%, 2%, 4%, 5%, 6%, 8% and 10% of foetal red cells were analysed by both methods.

RESULTS

Results for both methods were linear to 10% foetal red cells. Analysis using the Wilcoxon test found that there was no difference between the paired results of Trillium QuikQuant and the expected values of the spiked samples (P = 0.48). In contrast, Millipore anti-HbF FITC gave statistically higher results compared with both the expected values and Trillium QuikQuant anti-HbF FITC (P = 0.0003 and P < 0.0001, respectively). The Bland-Altman plot for Trillium QuikQuant showed a mean difference of only 0.06% below the expected values, whilst Millipore was 0.13% above. The analysis time with Trillium QuikQuant was approximately 40 min, requiring significantly less hands-on time than the Millipore method that required an additional four wash steps.

CONCLUSION

Trillium QuikQuant is a new precise, accurate and rapid flow cytometric kit method for the quantitation of FMH in both the antenatal and postpartum period.

摘要

简介

本研究评估了一种用于流式细胞术胎儿母体出血（FMH）定量的新产品，即 Trillium QuikQuant 抗 HbF FITC 试剂盒（美国 Trillium Diagnostics），并将其与 Millipore 抗 HbF FITC 方法进行了比较。

方法

使用这两种方法分析了 67 名产前或产后 RhD 阴性妇女的血液以及 108 份分别添加了 0.2%、0.4%、0.6%、2%、4%、5%、6%、8%和 10%胎儿红细胞的样本。

结果

两种方法的结果在 10%胎儿红细胞时均呈线性关系。使用 Wilcoxon 检验分析发现，Trillium QuikQuant 的配对结果与添加样本的预期值之间没有差异（P=0.48）。相比之下，Millipore 抗 HbF FITC 与预期值和 Trillium QuikQuant 抗 HbF FITC 相比，结果均具有统计学意义上的更高（P=0.0003 和 P<0.0001）。Trillium QuikQuant 的 Bland-Altman 图显示，其平均差值仅比预期值低 0.06%，而 Millipore 则高出 0.13%。使用 Trillium QuikQuant 的分析时间约为 40 分钟，所需的手工操作时间明显少于需要额外进行四个洗涤步骤的 Millipore 方法。