Kaiser Thorsten, Liebscher Karin, Scholz Ute, Pfrepper Christian, Netto Jeffrey, Drogies Tim, Tiebel Oliver, Knöfler Ralf, Krause Michael
Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig, Paul-List-Str., Leipzig, Germany.
Institute of Transfusion Medicine and Clinical Hemostaseology, Klinikum St. Georg gGmbH, Delitzscher Straße, Leipzig, Germany.
TH Open. 2022 Aug 22;6(3):e213-e220. doi: 10.1055/a-1827-7025. eCollection 2022 Jul.
Light transmission aggregometry (LTA) is regarded as the gold standard in platelet function diagnostics. However, there is a relevant degree of interlaboratory variability in practical applications. The aim of the present study was to develop a practicable laboratory comparison on LTA and to analyze differences and influencing factors in regard to standardization in five specialized hemostaseological centers. The study was performed on 30 patients in total. Each center performed LTA on blood samples from six healthy volunteers (three men and three women) using the inductors collagen (Col), adenosine diphosphate (ADP), arachidonic acid (ARA), and ristocetin. The LTA was performed three times using different methods as follows: (1) International Society on Thrombosis and Haemostasis recommendations with identical reagents, (2) in-house protocols and the identical reagents; and (3) in-house protocols and in-house reagents. A total of 396 measurements of 30 probands were performed. Even after standardization of the protocol and using identical reagents, there were significant differences between the centers regarding the final and maximum aggregation ( = 0.002 and <0.001) and further significant differences in the maximum and final aggregation according to the wavelength of the device used to measure the LTA (PAP-8: 430 nm, APACT 4004: 740 nm [ < 0.001 each]). Using identical reagents but individual inductor concentrations and laboratory protocols also resulted in different maximum and final aggregation. The largest differences were seen with Col and ristocetin; there were significant influences from the reagents' manufacturers in the results of aggregometry for the inductor Col ( < 0.01) but not for ADP, ARA, and ristocetin. In this study, we proved that there are significant influences from the used aggregometers, inductors concentrations, and manufacturers. These results illustrate the challenges and importance of standardization of LTA.
透光聚集法(LTA)被视为血小板功能诊断的金标准。然而,在实际应用中存在相当程度的实验室间变异性。本研究的目的是开展一项关于LTA的可行的实验室比较,并分析五个专业止血学中心在标准化方面的差异及影响因素。本研究共纳入30例患者。每个中心使用诱导剂胶原(Col)、二磷酸腺苷(ADP)、花生四烯酸(ARA)和瑞斯托霉素,对6名健康志愿者(3名男性和3名女性)的血样进行LTA检测。LTA采用以下不同方法进行3次检测:(1)使用相同试剂遵循国际血栓与止血学会的建议;(2)采用内部方案并使用相同试剂;(3)采用内部方案并使用内部试剂。共对30名受试者进行了396次检测。即使在方案标准化并使用相同试剂后,各中心在最终聚集和最大聚集方面仍存在显著差异(P = 0.002和<0.001),并且根据用于测量LTA的设备波长,在最大聚集和最终聚集方面进一步存在显著差异(PAP - 8:430nm,APACT 4004:740nm [各P < 0.001])。使用相同试剂但诱导剂浓度和实验室方案不同也导致最大聚集和最终聚集不同。Col和瑞斯托霉素的差异最大;诱导剂Col的聚集检测结果受试剂制造商的影响显著(P < 0.01),而ADP、ARA和瑞斯托霉素则不受影响。在本研究中,我们证明了所用聚集仪、诱导剂浓度和制造商存在显著影响。这些结果说明了LTA标准化的挑战和重要性。