An appropriate preclinical thrombogenicity evaluation of a blood-contacting device is important to reduce thrombosis and thromboembolism risks to patients. The in vitro platelet and leukocyte count assay, as described in the ASTM F2888 test standard, aims to assess thrombogenic potentials of blood-contacting materials. The goals of this study were to evaluate whether this standardized test method can effectively differentiate materials with different thrombogenic potentials and to investigate the impact of anticoagulation conditions on test sensitivity. Using human blood with various anticoagulation conditions, we performed the platelet and leukocyte count assays on four biomaterials and three positive control materials. We found that the use of sodium citrate anticoagulation as stipulated in the 2013 version of the ASTM F2888 standard cannot differentiate materials with different thrombogenic potentials. The modification to use low-concentration heparin, either with recalcified citrated blood or with direct heparinization, substantially improved the test sensitivity and enabled the assay to distinguish platelet count reduction between the positive controls and commonly used biomaterials. Leukocyte count was shown to be a much less sensitive indicator than platelet count for thrombogenicity evaluations of biomaterials. The findings from this study have been incorporated in the recent 2019 version of the ASTM F2888 standard.

中文翻译：

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用于生物材料和医疗器械血栓形成性筛选的血小板和白细胞计数测定：ASTM F2888 测试标准的评估和改进

对血液接触装置进行适当的临床前血栓形成性评估对于降低患者的血栓形成和血栓栓塞风险非常重要。如 ASTM F2888 测试标准所述，体外血小板和白细胞计数测定旨在评估血液接触材料的血栓形成潜力。本研究的目的是评估这种标准化测试方法是否可以有效地区分具有不同血栓形成潜力的材料，并研究抗凝条件对测试灵敏度的影响。我们使用具有各种抗凝条件的人体血液，对四种生物材料和三种阳性对照材料进行了血小板和白细胞计数测定。我们发现使用2013版ASTM F2888标准中规定的柠檬酸钠抗凝不能区分具有不同血栓形成潜能的材料。使用低浓度肝素的修改，无论是再钙化的柠檬酸血液还是直接肝素化，都大大提高了测试灵敏度，并使该测定能够区分阳性对照和常用生物材料之间的血小板计数减少。对于生物材料的血栓形成性评估，白细胞计数被证明是一个比血小板计数低得多的指标。这项研究的结果已被纳入最新的 2019 版 ASTM F2888 标准。无论是用重新钙化的柠檬酸血液还是直接肝素化，都大大提高了测试灵敏度，并使该测定能够区分阳性对照和常用生物材料之间的血小板计数减少。对于生物材料的血栓形成性评估，白细胞计数被证明是一个比血小板计数低得多的指标。这项研究的结果已被纳入最新的 2019 版 ASTM F2888 标准。无论是用重新钙化的柠檬酸血液还是直接肝素化，都大大提高了测试灵敏度，并使该测定能够区分阳性对照和常用生物材料之间的血小板计数减少。对于生物材料的血栓形成性评估，白细胞计数被证明是一个比血小板计数低得多的指标。这项研究的结果已被纳入最新的 2019 版 ASTM F2888 标准。