MONOCYTE ACTIVATION TEST BETTER ABLE TO DETECT NON-ENDOTOXIN PYROGENIC CONTAMINANTS IN MEDIAL PRODUCTS
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Accused Products
Abstract
An improved monocyte activation test is described that is better able to detect non-endotoxin pyrogens in medical products, in which a sample is incubated with a monocyte-containing reagent in an assay system comprising at least one surface comprising polypropylene. The invention also concerns assay systems for use in these tests that include at least one microtiter well having at least one interior surface comprising polypropylene and having a shape such that monocyte-containing reagent is concentrated in the well to provide greater cell to cell contact. The invention also relates to a diagnostic kit that can be used to test for the presence of non-endotoxin pyrogens in a sample.
7 Citations
52 Claims
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1-32. -32. (canceled)
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33. A method of testing a sample, comprising the steps of:
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combining a monocyte-containing reagent and the sample to be tested in a first assay system which includes at least one microtiter well shaped such that the monocyte-containing reagent is concentrated to provide greater cell to cell contact as compared to a flat-bottomed microtiter well, wherein the surface of the microtiter well comprises a polypropylene coating or the entire microtiter well is composed of polypropylene; incubating the monocyte-containing reagent and the sample; transferring the contents of the first assay system to a second assay system which comprises at least one surface treated with an antibody to the cytokine or endogenous mediator of the inflammatory response; and assaying the second assay system for the presence of cytokine or endogenous mediator bound to the antibody on the surface. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A method of testing a sample, comprising the steps of:
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combining a monocyte-containing reagent and the sample to be tested in a first assay system comprising (i) at least one microtiter well shaped such that the monocyte-containing reagent is concentrated to provide greater cell to cell contact as compared to a flat-bottomed microtiter well, wherein the surface of the microtiter well comprises a polypropylene coating or the entire microtiter well is composed of polypropylene and (ii) at least one surface treated with an antibody to the cytokine or endogenous mediator of the inflammatory response; incubating the monocyte-containing reagent and the sample; and assaying the assay system for the presence of cytokine or endogenous mediator bound to the antibody on the surface. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52)
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Specification