Monocyte Activation Test Better Able to Detect Non-Endotoxin Pyrogenic Contaminants in Medical Products
AssigneesBaxter International Inc., National Biological Standards Board, Baxter Healthcare S.A.
InventorsStephen Poole, Mehul Patel
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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.
Claims15
-32. (canceled)
A diagnostic kit comprising:
- (i) a microtiter plate comprising a plurality of microtiter wells shaped such that, when cells are contained in each well, the cells are concentrated, as compared to a flat-bottomed microtiter well, wherein the surface of each well comprises a polypropylene coating or is composed of polypropylene;
- and
- (ii) a cryopreserved monocyte-containing reagent, wherein the cryopreserved monocyte-containing reagent is provided to an end-user separately from the microtiter plate.
A method of culturing cells contained within a monocyte-containing reagent comprising the step of:
- combining the monocyte-containing reagent and a sample to be tested in an assay system which comprises at least one surface comprising polypropylene, wherein the monocyte-containing reagent (a) comprises peripheral blood mononuclear cells or monocytic cell line cells, (b) is in contact with the surface, and (c) is present in the assay system at a high cell density.
Dependencies are inferred from the claim text.