Assessment of light transmission aggregometry on the routine coagulation analyzer Sysmex CS-2500 using CE-marked agonists from Hyphen Biomed

Light transmission aggregometry (LTA) is still considered as the “gold standard” for platelet function assessment but, as acompletely manual technology, it is labour intensive. This challenge can be overcome by performing platelet aggregometry in anautomated method on a routine coagulation analyzer. We aimed to compare and correlate results obtained from a traditional manual LTA solution realized in our Reference Center with an optimized automated system using CE-marked agonist reagents. Platelet rich plasma from patients with suspected platelet disorders, von Willebrand disease or antiplatelet therapy have been assessed using a wide range of agonist concentrations. Results were expressed as Maximal Platelet Aggregation and correlation was analyzed using the Passing and Bablok regression test. Platelet aggregometry studies were performed in 49 samples. Maximal aggregation response with ADP (0.5-10 μM), collagen (2 mg/μL), ristocetin (1.2 mg/mL) and arachidonic acid (1 mM) agonists showed significant correlation between the two aggregometers (p< .001). We observed a more variable response using lowconcentrations of ADP (≤5 μM). Moreover, we also noted discrepancies with the low dose of ristocetin, showing excessive paradoxical agglutination with the CS-2500, suggesting that a lower ristocetin dose should be used with this system. These data show that CS-2500 has the advantages of a walk-away technology and the use of CE-marked reagents also permit the possibility of an easier certification.

光透比浊法血小板聚集试验（Light transmission aggregometry, LTA）目前仍被视为血小板功能评估的“金标准”，但作为完全手工化的技术，其劳动强度极高。这一局限可通过在常规凝血分析仪上以自动化方法开展血小板聚集试验得以解决。本研究旨在对比并关联本参考中心采用传统手工LTA方案所得结果，与使用经CE认证激动剂试剂的优化自动化系统的检测结果。研究纳入疑似血小板疾病、血管性血友病或接受抗血小板治疗的患者的富血小板血浆，使用一系列浓度梯度的激动剂进行检测。以最大血小板聚集率作为检测结果的表达形式，并采用Passing和Bablok回归检验分析相关性。本研究共纳入49份样本开展血小板聚集试验分析。针对腺苷二磷酸（ADP，0.5~10 μM）、胶原（2 mg/μL）、瑞斯托霉素（1.2 mg/mL）及花生四烯酸（1 mM）四种激动剂，两种检测方法的最大聚集反应均存在显著相关性（p<0.001）。研究观察到，当使用低浓度ADP（≤5 μM）时，检测结果的变异度更高。此外，还发现低剂量瑞斯托霉素的检测结果存在不一致：CS-2500系统出现了过度的反常凝集现象，提示该系统应使用更低剂量的瑞斯托霉素。上述数据表明，CS-2500系统具备无人值守检测技术的优势，且使用经CE认证的试剂也可简化认证流程。