Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
Anzac Research Institute, University of Sydney, Sydney, NSW, Australia.
Haemophilia. 2018 May;24(3):492-501. doi: 10.1111/hae.13446. Epub 2018 Feb 28.
Chromogenic substrate assays (CSA) to measure Factor IX (FIX) have recently become commercially available. However, information on their performance characteristics and use in diagnostic haemostasis laboratories remains limited.
To evaluate the Hyphen Biomed (Hyphen) and Rossix FIX CSAs on fully automated coagulation analysers and compare them to the FIX one-stage assay (OSA). This study was conducted in a tertiary referral haemostasis laboratory associated with a haemophilia treatment centre.
Automated CSA protocols were adapted to the Sysmex CS2500 (CS2500) and Diagnostica Stago STA-R (STA-R) analysers. Samples assayed were from healthy volunteers, haemophilia B patients and FIX deficient plasma spiked with either plasma derived, recombinant or extended half-life FIX products.
Reference intervals for Hyphen and Rossix assays were 73 IU/dL to 164 IU/dL and 73 IU/dL to 168 IU/dL, respectively, on the CS2500 analyser; and 84 IU/dL to 165 IU/dL for the Rossix assay on the STA-R. Repeatability across all method/analyser combinations resulted in CVs ranging from 0.8% to 5.4%. Between run reproducibility gave CVs <6.7% for all method/analyser combinations. In spiked samples, FIX recoveries were mostly within an acceptable limit of 100 ± 25% for BeneFIX , Rixubis and Alprolix with some differences between CSAs.
Both commercial factor FIX CSA kits can be adapted for Stago and Sysmex automated coagulation analysers. Reagent cost and workflow practices will need to be considered. These assays are potentially more consistent than OSA in measurement of replacement FIX products in haemophilia B patients.
最近，用于测定因子 IX（FIX）的显色底物测定法（CSA）已可商业化获得。然而，有关其性能特征以及在诊断性止血实验室中的应用的信息仍然有限。
评估 Hyphen Biomed（Hyphen）和 Rossix FIX CSA 在全自动凝血分析仪上的性能，并将其与 FIX 一步法测定法（OSA）进行比较。本研究在与血友病治疗中心相关联的三级转诊止血实验室中进行。
针对 Sysmex CS2500（CS2500）和 Diagnostica Stago STA-R（STA-R）分析仪，对自动 CSA 方案进行了调整。所分析的样本来自健康志愿者、血友病 B 患者和用血浆衍生的、重组的或延长半衰期的 FIX 产品进行了外源性添加的 FIX 缺乏血浆。
Hyphen 和 Rossix 测定法在 CS2500 分析仪上的参考区间分别为 73 IU/dL 至 164 IU/dL 和 73 IU/dL 至 168 IU/dL；在 STA-R 分析仪上，Rossix 测定法的参考区间为 84 IU/dL 至 165 IU/dL。在所有方法/分析仪组合中，重复性的变异系数（CV）范围为 0.8%至 5.4%。在所有方法/分析仪组合中，批间重现性的 CV 均<6.7%。在添加样本中，BeneFIX、Rixubis 和 Alprolix 的 FIX 回收率大多在可接受的 100±25%范围内，而不同 CSA 之间存在一些差异。
两种商业因子 FIX CSA 试剂盒均可适用于 Stago 和 Sysmex 全自动凝血分析仪。需要考虑试剂成本和工作流程实践。与 OSA 相比，这些测定法在测定血友病 B 患者的替代 FIX 产品时可能更具一致性。
