Variability in combinations of APTT reagent and substrate plasma for a one-stage clotting assay to measure factor VIII products

IF 2.2 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2024-03-01 DOI:10.1111/ijlh.14258

Atsuo Suzuki, Nobuaki Suzuki, Takeshi Kanematsu, Shuichi Okamoto, Naruko Suzuki, Shogo Tamura, Ryosuke Kikuchi, Akira Katsumi, Tetsuhito Kojima, Tadashi Matsushita

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Abstract

Introduction

An investigation of the suitability of reagents for measuring FVIII products in a one-stage clotting assay (OSA) showed variations in their FVIII activity (FVIII:C). Most studies have focused on the activated partial thromboplastin time (APTT) reagent rather than FVIII-deficient plasma (F8DP), even though the APTT-based OSA is comprised of APTT reagents and factor-deficient plasma.

Aim

A single-centre study was conducted to clarify variations in measurements of FVIII products in an OSA using a total of 12 reagent combinations, including four APTT reagents and three types of F8DP.

Methods

FVIII:C in nine types of FVIII product-spiked plasma was measured using an OSA with four different APTT reagents and three types of F8DP.

Results

F8DP-dependent variations were found in addition to differences derived from APTT reagents. Variations in target recovery (TR) were observed for NovoEight®, Eloctate®, and Jivi®. Reduced TR for Jivi was found only for Pathromtin SL in combination with congenital F8DP (F8DP-3). This lower TR was not observed with alternative manufacturing lots of F8DP-3. The reduced TR for Jivi might be related to impaired contact activation due to lower factor XI activity in F8DP-3.

Conclusion

In addition to APTT reagents, variations in F8DPs used for OSAs can also affect FVIII:C results. F8DPs as well as the APTT reagent used for OSA should be chosen with caution, and laboratories should evaluate reagents for F8DPs as they currently do for APTT reagents, especially when lot changes occur.

Abstract Image

查看原文本刊更多论文

用于测量因子 VIII 产品的单阶段凝血测定的 APTT 试剂和底物血浆组合的变异性。

导言：一项关于在单阶段凝血测定（OSA）中测定 FVIII 产物的试剂适用性的调查显示，这些试剂的 FVIII 活性（FVIII:C）存在差异。大多数研究的重点是活化部分凝血活酶时间（APTT）试剂，而不是 FVIII 缺乏血浆（F8DP），尽管基于 APTT 的 OSA 是由 APTT 试剂和因子缺乏血浆组成的。目的：我们进行了一项单中心研究，以澄清在使用 12 种试剂组合（包括 4 种 APTT 试剂和 3 种 F8DP）的 OSA 中 FVIII 产物测量值的变化：方法：使用 OSA 测量九种 FVIII 产品加标血浆中的 FVIII:C，其中包括四种不同的 APTT 试剂和三种 F8DP：结果：除了 APTT 试剂导致的差异外，还发现了 F8DP 导致的差异。观察到 NovoEight®、Eloctate® 和 Jivi® 的目标恢复（TR）存在差异。仅在 Pathromtin SL 与先天性 F8DP（F8DP-3）联合使用时发现 Jivi 的 TR 值降低。在使用其他生产批次的 F8DP-3 时，未发现 TR 降低的情况。Jivi 的 TR 值降低可能与 F8DP-3 中因子 XI 活性较低导致接触激活受损有关：除 APTT 试剂外，用于 OSA 的 F8DPs 的变化也会影响 FVIII:C 的结果。应谨慎选择 F8DPs 和用于 OSA 的 APTT 试剂，实验室应像目前评估 APTT 试剂一样评估 F8DPs 试剂，尤其是当批次发生变化时。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.