Cozzi Maria Rita, Del Ben Fabio, Corso Chiara, Steffan Agostino
Centro di Riferimento Oncologico (CRO) Aviano, National Cancer Institute, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Immunopathology and Cancer Biomarkers Unit, Department of Cancer Research and Advanced Diagnostics, Aviano, Italy.
Res Pract Thromb Haemost. 2024 Jul 22;8(5):102525. doi: 10.1016/j.rpth.2024.102525. eCollection 2024 Jul.
Thrombotic thrombocytopenic purpura, particularly its immune-mediated variant (iTTP), necessitates accurate diagnostic approaches for effective management.
To compare a chemiluminescence immunoassay (CLIA) and an enzyme-linked immunosorbent assay (ELISA) for testing ADAMTS-13 activity and detecting anti-ADAMTS-13 autoantibodies (AAbs) in patients with iTTP.
This study involved 31 paired samples from 12 iTTP patients. ADAMTS-13 activity was measured using the HemosIL AcuStar (Instrumentation Laboratory, CLIA) and Technozym (Technoclone) activity assay (ELISA). The presence of AAbs was assessed using Technozym ADAMTS-13-INH assay (ELISA) and HemosIL AcuStar activity (CLIA) within a Bethesda assay following mixing with normal pool plasma. von Willebrand factor (VWF) multimers were analyzed using the HYDRASYS-2 SCAN system and the HYDRAGEL 5- or 11-VW Multimer kits (Sebia). VWF activity levels were measured with the HemosIL AcuStar VWF:GPIbR on the ACL AcuStar Analyzer (IL).
For ADAMTS-13 activity, a strong linear relationship and no bias between CLIA and ELISA were confirmed (slope = 1.01 [0.91, 1.11], intercept = 0.00 [-0.47, 0]). However, significant discrepancies were found in AAb detection during remission phases with ADAMTS-13 activity between 10% and 50%, with CLIA and ELISA showing significant divergence ( < .001, Cohen's = 0.34). Consistently, VWF multimers and activity levels exhibited significantly different values between remission samples with ADAMTS-13 activity below 50% and above 50%. In longitudinal analysis of patients with multiple iTTP relapses, positivity to CLIA appears to precede ELISA in predicting exacerbations.
While CLIA and ELISA might be interchangeable for assessing ADAMTS-13 activity, they are not equivalent for detecting AAbs, particularly in patients in clinical remission with ADAMTS-13 activity between 10% and 50%.
血栓性血小板减少性紫癜，尤其是其免疫介导型（iTTP），需要准确的诊断方法以进行有效管理。
比较化学发光免疫分析法（CLIA）和酶联免疫吸附测定法（ELISA）检测iTTP患者中ADAMTS-13活性及抗ADAMTS-13自身抗体（AAbs）的效果。
本研究纳入了12例iTTP患者的31对样本。使用HemosIL AcuStar（仪器实验室，CLIA）和Technozym（Technoclone）活性测定法（ELISA）测量ADAMTS-13活性。与正常混合血浆混合后，使用Technozym ADAMTS-13-INH测定法（ELISA）和HemosIL AcuStar活性（CLIA）在贝塞斯达测定法中评估AAbs的存在情况。使用HYDRASYS-2 SCAN系统和HYDRAGEL 5-或11-VW多聚体试剂盒（Sebia）分析血管性血友病因子（VWF）多聚体。在ACL AcuStar分析仪（IL）上使用HemosIL AcuStar VWF:GPIbR测量VWF活性水平。
对于ADAMTS-13活性，CLIA和ELISA之间确认存在强线性关系且无偏差（斜率 = 1.01 [0.91, 1.11]，截距 = 0.00 [-0.47, 0]）。然而，在ADAMTS-13活性为10%至50%的缓解期检测AAbs时发现了显著差异，CLIA和ELISA显示出显著差异（< .001，科恩氏 = 0.34）。一致地，ADAMTS-13活性低于50%和高于50%的缓解期样本之间，VWF多聚体和活性水平表现出显著不同的值。在对多次复发的iTTP患者进行的纵向分析中，CLIA阳性似乎在预测病情加重方面先于ELISA。
虽然CLIA和ELISA在评估ADAMTS-13活性方面可能可互换，但在检测AAbs方面并不等效，尤其是在ADAMTS-13活性为10%至50%的临床缓解患者中。
