Wong Wan Hui, Tan Chuen Wen, Abdul Khalid Nabeelah Binti, Dalimoenthe Nadjwa Zamalek, Yip Christina, Tantanate Chaicharoen, Lim Rodelio D, Kim Ji Hyun, Ng Heng Joo
Department of Haematology, Singapore General Hospital, Singapore 169608, Singapore.
Department of Pathology, Hospital Pulau Pinang, Pulau Pinang 10990, Malaysia.
Diagnostics (Basel). 2023 Jul 22;13(14):2447. doi: 10.3390/diagnostics13142447.
(1) Background: The activated partial thromboplastin time (APTT)- based clot waveform analysis (CWA) quantitatively extends information obtained from the APTT waveform through its derivatives. However, pre-analytical variables including reagent effects on the CWA parameters are poorly understood and must be standardized as a potential diagnostic assay. (2) Methods: CWA was first analysed with patient samples to understand reagent lot variation in three common APTT reagents: Pathromtin SL, Actin FS, and Actin FSL. A total of 1055 healthy volunteers were also recruited from seven institutions across the Asia-Pacific region and CWA data were collected with the Sysmex CS analysers. (3) Results: CWA parameters varied less than 10% between lots and the linear mixed model analysis showed few site-specific effects within the same reagent group. However, the CWA parameters were significantly different amongst all reagent groups and thus reagent-specific 95% reference intervals could be calculated using the nonparametric method. Post-hoc analysis showed some degree of influence by age and gender with weak correlation to the CWA (r < 0.3). (4) Conclusions: Reagent type significantly affects APTT-based CWA with minimal inter-laboratory variations with the same coagulometer series that allow for data pooling across laboratories with more evidence required for age- and gender-partitioning.
(1) 背景：基于活化部分凝血活酶时间（APTT）的凝血波形分析（CWA）通过其导数定量扩展了从APTT波形获得的信息。然而，包括试剂对CWA参数影响在内的分析前变量了解甚少，作为一种潜在的诊断检测方法必须进行标准化。(2) 方法：首先用患者样本分析CWA，以了解三种常见APTT试剂（Pathromtin SL、Actin FS和Actin FSL）的试剂批次差异。还从亚太地区的七个机构招募了1055名健康志愿者，并使用Sysmex CS分析仪收集CWA数据。(3) 结果：各批次间CWA参数变化小于10%，线性混合模型分析显示同一试剂组内几乎没有特定部位的影响。然而，所有试剂组之间的CWA参数存在显著差异，因此可以使用非参数方法计算特定试剂的95%参考区间。事后分析显示年龄和性别有一定程度的影响，与CWA的相关性较弱（r < 0.3）。(4) 结论：试剂类型对基于APTT的CWA有显著影响，同一凝血仪系列的实验室间差异最小，这使得跨实验室的数据合并成为可能，但年龄和性别划分需要更多证据。
