Favaloro Emmanuel J, Arunachalam Sandya, Dean Elysse, Salwa Mahzuza, Ahuja Monica, Connelly Lynne, Chapman Kent, Vong Ronny, Pasalic Leonardo
Department of Haematology, Sydney Centres for Thrombosis and Haemostasis, Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital, Westmead, New South Wales, Australia.
Faculty of Science and Health, Charles Sturt University, Wagga Wagga, New South Wales, Australia.
Int J Lab Hematol. 2025 Aug;47(4):720-729. doi: 10.1111/ijlh.14447. Epub 2025 Feb 19.
Activated protein C resistance (APCR) represents a risk factor for thrombosis and is usually due to factor V Leiden (FVL). Clinicians may order either test (i.e., APCR or FVL) to help assess 'thrombophilia' in patients who present with thrombosis. APCR testing is usually achieved using clot-based assays, whereas FVL is assessed by genetic testing. There are advantages and disadvantages to either approach.
We report updated findings for APCR testing in our geographic region, in part using recent data from the RCPAQAP, an international external quality assessment (EQA) program, with some 50-60 participants for APCR testing over the past decade. Data have been updated to cover the past 13 years (2010-2023 inclusive), with four samples assessed each year, but with a primary focus on new data from 2020 to 2023 inclusive. In addition, data for APCR testing over several years from four large tertiary-level hospital laboratories have been assessed following a recent change in instrumentation and haemostasis methods.
EQA data continue to show variable performance in both numerical values and their interpretation for APCR testing, with certain methods providing more consistently correct findings than others. In addition, participant interpretation of their own numerical values and transcription errors seem problematic. Finally, the change in recent laboratory testing has also evidenced local improvements.
APCR assays and testing laboratories continue to show variability in performance, with two methods (Pefakit and Staclot) showing the best performance overall. Targeted education may be of benefit, as most of the errors appear to originate from a small proportion of laboratories.
活化蛋白C抵抗(APCR)是血栓形成的一个风险因素,通常由因子V莱顿(FVL)引起。临床医生可能会进行这两项检测(即APCR或FVL)中的任何一项,以帮助评估出现血栓形成的患者的“易栓症”。APCR检测通常使用基于凝血的检测方法,而FVL则通过基因检测进行评估。这两种方法都有优缺点。
我们报告了我们所在地理区域APCR检测的最新结果,部分使用了来自国际外部质量评估(EQA)计划RCPAQAP的近期数据,在过去十年中约有50 - 60名参与者进行APCR检测。数据已更新以涵盖过去13年(包括2010年至2023年),每年评估四个样本,但主要关注2020年至2023年(包括)的新数据。此外,在仪器和止血方法最近发生变化后,对四家大型三级医院实验室多年来的APCR检测数据进行了评估。
EQA数据在APCR检测的数值及其解释方面继续显示出不同的表现,某些方法提供的结果比其他方法更一致正确。此外,参与者对自己数值的解释和转录错误似乎存在问题。最后,最近实验室检测的变化也证明了当地的改进。
APCR检测方法和检测实验室的性能继续存在差异,两种方法(Pefakit和Staclot)总体表现最佳。有针对性的教育可能会有所帮助,因为大多数错误似乎源于一小部分实验室。