MONOCYTE ACTIVATION TEST BETTER ABLE TO DETECT NON-ENDOTOXIN PYROGENIC CONTAMINANTS IN MEDIAL PRODUCTS
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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.
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Citations
58 Claims
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1-32. -32. (canceled)
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33. A diagnostic kit comprising:
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a. a first assay system which includes at least one microtiter well shaped such that a 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 b. a second assay system which comprises at least one surface treated with an antibody to the cytokine or endogenous mediator of the inflammatory response; c. instructions for incubating in the first assay system a monocyte-containing reagent and a sample to be tested, transferring the contents of the first assay system to the second assay system, and assaying the second system for the presence of cytokine or endogenous mediator bound to the antibody. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A diagnostic kit comprising:
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a. an 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 a cytokine or an endogenous mediator of the inflammatory response b. instructions for combining a monocyte-containing reagent and the sample to be tested in the assay system, 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. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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57. A diagnostic kit comprising:
- a microtiter plate comprising a plurality of microtiter wells shaped such that cells contained in each well are concentrated as compared to a flat-bottomed microtiter well, a surface of said well comprising polypropylene; and
a cryopreserved monocyte-containing reagent which is contained in the wells of said plate, wherein the monocyte-containing reagent comprises cryopreserved peripheral blood mononuclear cells or cryopreserved monocytic cell line cells, is in contact with the surfaces of said wells, and is present in said well at a high cell density.
- a microtiter plate comprising a plurality of microtiter wells shaped such that cells contained in each well are concentrated as compared to a flat-bottomed microtiter well, a surface of said well comprising polypropylene; and
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58. A diagnostic kit comprising:
- an assay system for detecting non-endotoxin pyrogens in a parenterally administered medical product, said assay system comprising a microtiter plate comprising a plurality of microtiter wells shaped such that cells contained in each well are concentrated as compared to a flat-bottomed microtiter well, a surface of said well comprising polypropylene;
a cryopreserved monocyte-containing reagent which is contained in the wells of said plate, wherein the monocyte-containing reagent comprises cryopreserved whole blood and is in contact with the surfaces of said wells; and
an antibody to IL-6.
- an assay system for detecting non-endotoxin pyrogens in a parenterally administered medical product, said assay system comprising a microtiter plate comprising a plurality of microtiter wells shaped such that cells contained in each well are concentrated as compared to a flat-bottomed microtiter well, a surface of said well comprising polypropylene;
Specification