用于医疗器械材料体外血栓形成性评估的分子生物标记物。

IF 3.2 4区 医学 Q2 ENGINEERING, BIOMEDICAL Journal of biomedical materials research. Part B, Applied biomaterials Pub Date : 2024-09-28 DOI:10.1002/jbm.b.35491
Mehulkumar Patel, Anna Parrish, Carlos Serna III, Megan Jamiolkowski, Keerthana Srinivasan, Richard Malinauskas, Qijin Lu
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引用次数: 0

摘要

为了开发用于评估医疗器械材料的标准化体外血栓形成试验方法,研究了三种血小板活化生物标志物--β-血栓球蛋白(β-TG)、血小板因子 4(PF4)、可溶性 p-选择素(CD62P)和一种血浆凝血标志物--凝血酶-抗凝血酶复合物(TAT)。将 6 名健康志愿者的全血抽入抗凝剂柠檬酸葡萄糖溶液 A 中,在 0.5-1.5 U U/mL 的浓度范围内进行再钙化和肝素化。血液与具有不同血栓形成潜能的测试材料在 37°C 下孵育 60 分钟,材料表面积与血液体积比为 6 cm2/mL。孵育结束后,测量血小板计数,然后离心血液,制备贫血小板血浆(PPP)和无血小板血浆(PFP),用于生物标记物的酶联免疫吸附分析。结果表明,在肝素浓度为 1.0 至 1.5 U/mL时,所有四种标记物都能有效区分不同血栓形成潜能的材料。当使用献血者特异性肝素浓度(由活化凝血时间决定)时,标记物能够一致地区分所有献血者的血液。此外,使用 PFP 代替 PPP 进一步提高了测试方法区分血栓形成材料与阴性对照β-TG 和 TAT 的能力。此外,血小板活化标记物还能检测二磷酸腺苷(ADP)诱导的可逆性血小板活化。总之,所有三种血小板活化标记物(β-TG、PF4 和 CD62P)都能区分不同材料的血栓形成潜能,并检测 ADP 诱导的可逆性血小板活化。使用供体特异性肝素浓度和 PFP 可提高检测的一致性和灵敏度。同样的测试条件也适用于凝血标记物 TAT 的测量。
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Molecular Biomarkers for In Vitro Thrombogenicity Assessment of Medical Device Materials

To develop standardized in vitro thrombogenicity test methods for evaluating medical device materials, three platelet activation biomarkers, beta-thromboglobulin (β-TG), platelet factor 4 (PF4), soluble p-selectin (CD62P), and a plasma coagulation marker, thrombin–antithrombin complex (TAT), were investigated. Whole blood, drawn from six healthy human volunteers into Anticoagulant Citrate Dextrose Solution A was recalcified and heparinized over a concentration range of 0.5–1.5 U/mL. The blood was incubated with test materials with different thrombogenic potentials for 60 min at 37°C, using a 6 cm2/mL material surface area to blood volume ratio. After incubation, the blood platelet count was measured before centrifuging the blood to prepare platelet-poor plasma (PPP) and platelet-free plasma (PFP) for enzyme-linked immunosorbent assay analysis of the biomarkers. The results show that all four markers effectively differentiated the materials with different thrombogenic potentials at heparin concentrations from 1.0 to 1.5 U/mL. When a donor-specific heparin concentration (determined by activated clotting time) was used, the markers were able to differentiate materials consistently for blood from all the donors. Additionally, using PFP instead of PPP further improved the test method's ability to differentiate the thrombogenic materials from the negative control for β-TG and TAT. Moreover, the platelet activation markers were able to detect reversible platelet activation induced by adenosine diphosphate (ADP). In summary, all three platelet activation markers (β-TG, PF4, and CD62P) can distinguish thrombogenic potentials of different materials and detect ADP-induced reversible platelet activation. Test consistency and sensitivity can be enhanced by using a donor-specific heparin concentration and PFP. The same test conditions are applicable to the measurement of coagulation marker TAT.

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来源期刊
CiteScore
7.50
自引率
2.90%
发文量
199
审稿时长
12 months
期刊介绍: Journal of Biomedical Materials Research – Part B: Applied Biomaterials is a highly interdisciplinary peer-reviewed journal serving the needs of biomaterials professionals who design, develop, produce and apply biomaterials and medical devices. It has the common focus of biomaterials applied to the human body and covers all disciplines where medical devices are used. Papers are published on biomaterials related to medical device development and manufacture, degradation in the body, nano- and biomimetic- biomaterials interactions, mechanics of biomaterials, implant retrieval and analysis, tissue-biomaterial surface interactions, wound healing, infection, drug delivery, standards and regulation of devices, animal and pre-clinical studies of biomaterials and medical devices, and tissue-biopolymer-material combination products. Manuscripts are published in one of six formats: • original research reports • short research and development reports • scientific reviews • current concepts articles • special reports • editorials Journal of Biomedical Materials Research – Part B: Applied Biomaterials is an official journal of the Society for Biomaterials, Japanese Society for Biomaterials, the Australasian Society for Biomaterials, and the Korean Society for Biomaterials. Manuscripts from all countries are invited but must be in English. Authors are not required to be members of the affiliated Societies, but members of these societies are encouraged to submit their work to the journal for consideration.
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