Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital.
Sydney Centres for Thrombosis and Haemostasis, Westmead.
Blood Coagul Fibrinolysis. 2022 Oct 1;33(7):402-411. doi: 10.1097/MBC.0000000000001155. Epub 2022 Jul 22.
Coagulation factor testing is commonly performed within haemostasis laboratories, either to assess for bleeding disorders, such as haemophilia, or to investigate unexplained prolongation in routine coagulation assays. The aim of this evaluation was to harmonize procedures and normal reference ranges (NRRs) for investigation of coagulation factors on the ACL TOP 50 family of instruments in a large laboratory network. We employed comparative evaluations using newly installed ACL TOPs 550 and 750 and HemosIL reagents vs. existing 'reference' instrumentation and reagents, predominantly Stago and Siemens, as well as assessment of factor sensitivity in routine coagulation assays, prothrombin time (PT) and activated partial thromboplastin time (APTT). Also, establishment of coagulation factor NRRs using normal plasma samples. HemosIL factor assays showed good comparability with the existing reference methods ( R > 0.9). Factor sensitivity for PT and APTT assays were acceptable at around 30 U/dl. NRRs were established and harmonized across the laboratory network. This evaluation of factor testing on ACL TOP 50 Family instruments identified overall acceptable performance using Werfen reagents and enabled harmonization of coagulation factor testing in our large network.
凝血因子检测通常在止血实验室中进行，目的是评估出血性疾病，如血友病，或调查常规凝血检测中不明原因的延长。本次评估旨在协调在大型实验室网络中使用 ACL TOP 50 系列仪器检测凝血因子的程序和正常参考范围 (NRR)。我们采用了新安装的 ACL TOPs 550 和 750 与 HemosIL 试剂与现有“参考”仪器和试剂（主要是 Stago 和 Siemens）的比较评估，以及常规凝血检测（PT 和 APTT）中因子敏感性的评估。此外，还使用正常血浆样本建立了凝血因子 NRR。HemosIL 因子检测与现有的参考方法具有良好的可比性（R>0.9）。PT 和 APTT 检测的因子敏感性在 30U/dl 左右可接受。在整个实验室网络中建立并协调了 NRR。本次 ACL TOP 50 系列仪器的因子检测评估确定了使用 Werfen 试剂的整体可接受性能，并实现了我们大型网络中凝血因子检测的协调。
