T/CSBM 0046-2024 Coating anticoagulant performance in vitro test method

Scope

Scope: This document specifies the general principles, test methods, and reporting requirements for in vitro testing of the anticoagulant properties of coatings. This document applies to anticoagulant coatings that are firmly fixed on the surface of materials or devices through strong adhesion. This document does not apply to coatings that can be rapidly washed off or released from the surface. Main technical content: 5 Test methods for protein adsorption testing 5.1.1 Overview When blood comes into contact with medical devices, the device surface rapidly adsorbs plasma proteins such as fibrinogen. Adsorbed plasma proteins can further cause massive platelet adhesion, ultimately leading to coagulation. Therefore, evaluating the adsorption of plasma proteins on the device surface can serve as an important indicator of the coating's anticoagulant performance. 5.1.2 Method I 5.1.2.1 Principle Through the ELISA indirect method, a certain amount of fibrinogen (Fg) is adsorbed on the sample surface as an antigen. The adsorbed Fg sample is first combined with a specific fibrinogen antibody, then an enzyme-labeled secondary antibody is added to form a complex. Finally, a substrate reaction produces a colorimetric signal to detect the amount of Fg adsorbed on the sample. 5.1.2.2 Test procedure After the sample is immersed in a Fg solution configured with pH 7.4 buffer for 1 h to 4 h, the sample is removed and gently washed to remove loosely adsorbed Fg on the surface. The sample is placed in a container and successively added with a fibrinogen antibody and an enzyme-labeled secondary antibody for binding. Then, a substrate reagent and a termination reagent are added. The absorbance value of the reaction solution at the maximum absorption wavelength is measured. By comparing it with that of a coating-free sample of the same material, the difference in Fg adsorption between the coated and uncoated samples can be indirectly reflected. Note: When preparing large-volume or thi

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