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Abstract

A method of evaluating the biocompatibility of a medical device (mainly a material to be in contact with blood). An aqueous nucleated cell-containing solution such as collected blood is brought into contact with the surface of a material for a definite period of time in vitro and then the cell-containing liquid is collected. Next, an RNA fraction is extracted from the cells and cDNA are constructed with the use of reverse transcriptase. Then the expression level of a specific gene is quantified by the real time PCR method or the DNA array method. Separately, the above procedure is repeated but not bringing into contact with the material and the expression level of the specific gene in the cells is quantified. Then the expression levels thus quantified are compared with each other. A material showing a former expression level closer to the latter level has the higher biocompatibility. Using this method, a functional change in cells can be conveniently, quantitatively and highly sensitively evaluated in vitro, compared with the conventional methods. By comparing changes in expression level of urokinase plasminogen activator receptor gene or urokinase plasminogen activator receptor protein, a functional change in cells can be evaluated from a viewpoint available in none of the conventional methods. By regulating endotoxin contamination, the true change in cells by the material per se can be evaluated. Materials for treating a body fluid having been evaluated by the above method; a substance for evaluating biocompatibility; and a method of selecting an evaluating marker.

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