Augustsson Cecilia, Norström Eva, Andersson Nadine Gretenkort, Zetterberg Eva, Astermark Jan, Strandberg Karin
Division of Laboratory Medicine, Coagulation Department of Clinical Chemistry and Pharmacology University and Regional Laboratories Region Skåne Malmö Sweden.
Department of Hematology, Oncology and Radiation Physics Center for Thrombosis and Hemostasis Skåne University Hospital Lund University Malmö Sweden.
Res Pract Thromb Haemost. 2020 Aug 11;4(7):1114-1120. doi: 10.1002/rth2.12421. eCollection 2020 Oct.
Monitoring hemophilia treatment with extended half-life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one-stage assay (OSA) and the chromogenic substrate assay (CSA).
The aim of this study was to evaluate and compare different factor assays and global coagulation methods.
Factor VIII (FVIII) and IX (FIX) activities and global assay parameters were analyzed in pre- and postinfusion samples (5 patients 2 samples/product/method).
Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA. The correlation was excellent ( ≥ .97) while biases of 42%-72% of mean (CSA-OSA) were obtained. With FVIII (OSA) as independent variable, the correlations to kaolin clot time (CT) and thrombin generation assay (TGA) peak were modest ( = .71-.72 and .64-.65, respectively), except for Nuwiq for which there was a poor correlation to TGA peak ( = .08). Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA-OSA), and the correlation was excellent ( = .96). With FIX (CSA) as independent variable for both Alprolix and Refixia, the correlations to Innovin CT and TGA peaks were weak ( = .33-.45 and .44-.76, respectively).
Our data show that factor activity assays differ between methods used and agents. These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half-life products. Global assays gave complementary information indicated by the modest correlations to factor activities.
对于凝血实验室而言，使用半衰期延长产品监测血友病治疗颇具挑战性，因为因子检测在单步检测法（OSA）和发色底物检测法（CSA）所获结果之间可能显示出显著差异。
本研究旨在评估和比较不同的因子检测方法及整体凝血方法。
对输注前和输注后样本（5例患者，每种产品/方法2份样本）中的凝血因子VIII（FVIII）和IX（FIX）活性以及整体检测参数进行分析。
与OSA相比，使用CSA检测含FVIII产品（NovoEight、Elocta和Nuwiq）的样本时活性水平更高。相关性极佳（≥0.97），而（CSA - OSA）的偏差为均值的42% - 72%。以FVIII（OSA）作为自变量，与高岭土凝血时间（CT）和凝血酶生成检测（TGA）峰值的相关性一般（分别为0.71 - 0.72和0.64 - 0.65），Nuwiq与TGA峰值的相关性较差（= 0.08）。含FIX产品Alprolix的样本活性水平差异较小（CSA - OSA），相关性极佳（= 0.96）。以Alprolix和Refixia的FIX（CSA）作为自变量，与Innovin CT和TGA峰值的相关性较弱（分别为0.33 - 0.45和0.44 - 0.76）。
我们的数据表明，因子活性检测方法因所使用的方法和试剂而异。这些差异表明，在用半衰期延长产品监测血友病治疗时，凝血实验室采用多种检测方法的价值。整体检测提供了与因子活性一般相关性所表明的补充信息。
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