Test for determining pyrogenic effect of a material
First Claim
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1. A method for evaluating safety or possible contamination of a product for use with humans or animals, by a pyrogen test comprising the steps of:
- exposing a product intended for use with humans or animals to whole blood of a human in vitro or an animal in vitro;
followed bysubjecting a sample of the whole blood to an assay to determine whether the exposure induces formation of endogenous pyrogen in the sample;
whereby, the formation of endogenous pyrogen indicates the presence of an exogenous fever inducing agent in said product.
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Abstract
A method of ascertaining the pyrogenicity of a material involves exposing to the material a sample of whole blood from a human or an amimal, followed by determining whether the exposure induces formation of endogenous pyrogen in the sample.
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20 Claims
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1. A method for evaluating safety or possible contamination of a product for use with humans or animals, by a pyrogen test comprising the steps of:
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exposing a product intended for use with humans or animals to whole blood of a human in vitro or an animal in vitro;
followed bysubjecting a sample of the whole blood to an assay to determine whether the exposure induces formation of endogenous pyrogen in the sample; whereby, the formation of endogenous pyrogen indicates the presence of an exogenous fever inducing agent in said product. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification