Pyrogenicity test for use with automated immunoassay systems
AssigneesBaxter International Inc., National Institute for Biological Standards and Control
InventorsMehul Patel, Stephen Poole
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Abstract
The invention concerns an improved pyrogenicity test for use in automated immunoassay systems, in which a sample is incubated with a monocyte-containing reagent in a pyrogen-free assay system preferably comprising a surface coated with pyrogen-free anti-cytokine antibodies. The invention also concerns pyrogen-free assay systems coated with pyrogen-free antibodies for use in these tests. The invention also relates to a test to measure the basal production of endogenous mediators of the inflammatory response by leukocytes and a method of measuring the capacity of a leukocyte to respond to a stimuli.
Claims35
A method of detecting pyrogens in a sample comprising the steps of:
- a) combining a pyrogen-free monocyte-containing reagent and the sample to be tested in a pyrogen-free assay system, wherein the assay system comprises at least one surface treated with a pyrogen-free antibody to a cytokine;
- and
- b) assaying the assay system for the presence of cytokine bound to the antibody on the surface;
- whereby an elevated level of cytokine bound to the surface indicates the presence of pyrogens in the sample tested.
A pyrogen-free assay system wherein the assay system comprises a surface coated with a pyrogen-free antibody to a cytokine.
A method of detecting pyrogens in a sample comprising the steps of:
- a) combining a pyrogen-free monocyte-containing reagent and the sample to be tested in a pyrogen-free assay system, wherein the assay system comprises at least one surface treated with a pyrogen-free antibody to an endogenous mediator of the inflammatory response;
- and
- b) assaying the assay system for the presence of the mediator bound to the antibody on the surface;
- whereby an elevated level of the mediator bound to the surface indicates the presence of pyrogens in the sample tested.
A method of measuring the capacity of a leukocyte to respond to a stimuli comprising the steps of:
- a) combining a pyrogen-free leukocyte-containing reagent and a stimuli in a pyrogen-free assay system, wherein the assay system comprises at least one surface treated with a pyrogen-free antibody to an endogenous mediator of the inflammatory response;
- and
- b) assaying the assay system for the presence of the mediator bound to the antibody on the surface;
- whereby an elevated level of the mediator bound to the surface indicates the response of the leukocyte to the stimuli.
A method of measuring the basal production of endogenous mediators of the inflammatory response by leukocytes comprising the steps of:
- a) adding a pyrogen-free leukocyte-containing reagent to a pyrogen-free assay system, wherein the assay system comprises at least one surface treated with a pyrogen-free antibody to an endogenous mediator of the inflammatory response;
- and
- b) assaying the assay system for the presence of the mediator bound to the antibody on the surface;
- whereby the amount of mediator bound to the surface indicates the basal production of endogenous mediators of the inflammatory response by the leukocytes.
Dependencies are inferred from the claim text.