Rapid and sensitive method for quantitative determination of the level of heparin—PF4 complex induced immunoglobulin antibodies
AssigneeBioMedomics, Inc.
InventorsXue-feng Wang, Xuejie Wang
Life of this patent
Estimating the term…
Abstract
Disclosed herein is a lateral flow immuno-assay system capable of rapidly, cost effectively, and quantitatively detecting and assessing the level of HIT antibodies in body fluids of a patient. Also taught are methods for employing the system to assist in diagnosis of HIT, and for screening or detecting a changing titer of HIT antibodies in the body fluids of a patient to determine susceptibility toward HIT.
Claims18
A method of assisting in the diagnosis of heparin induced thrombocytopenia, in a patient, comprising quantitatively determining if a body fluid level of heparin-PF4 complex induced immunoglobulin antibodies in the patient is above a predetermined range using a point-of-care lateral flow immunoassay system, wherein the system comprises:
- a) a linear membrane of an inert, fibrous material capable of supporting movement of liquids by capillary flow, affixed to a supporting backing, wherein
- i) the membrane is zoned into a sample pad, a conjugate zone, a test line, a reference line, and a wicking pad, wherein each zone is separated from its adjacent zone by a flow zone,
- ii) protein A, which is affixed to an electromagnetic radiation absorbing or emitting label, is in the conjugate zone,
- iii) a heparin-platelet factor 4 complex is immobilized on the test line,
- iv) an antibody binding ligand capable of binding with the protein A is immobilized at the reference line, and
- b) a means for quantitatively measuring the electromagnetic radiation absorbed or emitted at the test line by the label affixed to protein A.
A method of screening a patient for susceptibility to heparin induced thrombocytopenia comprising determining by means of a point-of-care lateral flow immunoassay system:
- a) if heparin-PF4 complex induced immunoglobulin antibodies are present in a body fluid of the patient, and
- b) if the antibodies are present in the body fluid, quantitatively determining the level of the antibodies
- wherein the system comprises
- a) a linear membrane of an inert, fibrous material capable of supporting movement of liquids by capillary flow, affixed to a supporting backing, wherein
- i) the membrane is zoned into a sample pad, a conjugate zone, a test line, a reference line, and a wicking pad, wherein each zone is separated from its adjacent zone by a flow zone,
- ii) protein A, which is affixed to an electromagnetic radiation absorbing or emitting label, is in the conjugate zone,
- iii) a heparin-platelet factor 4 complex is immobilized on the test line,
- iv) an antibody binding ligand capable of binding with the protein A is immobilized at the reference line, and
- b) a means for quantitatively measuring the electromagnetic radiation absorbed or emitted at the test line by the label affixed to protein A.
A method for assisting a physician in assessing a patient's vulnerability to heparin induced thrombocytopenia in a patient being administered heparin or a heparin containing medication comprising:
- a) determining a changing titer of heparin-PF4 complex induced immunoglobulin antibodies, judged by a physician to be indicative of a patient's vulnerability, or
- b) determining the rate of change of the titer of heparin-PF4 complex induced immunoglobulin antibodies as a function of time, judged by a physician to be indicative of a patient's vulnerability,
- by making multiple assays of a body fluid level of heparin-PF4 complex induced immunoglobulin antibodies in the patient over a period of time using a rapid, cost effective, quantitative lateral flow immunoassay system, wherein the system comprises
- a) a linear membrane of an inert, fibrous material capable of supporting movement of liquids by capillary flow, affixed to a supporting backing, wherein
- i) the membrane is zoned into a sample pad, a conjugate zone, a test line, a reference line, and a wicking pad, wherein each zone is separated from its adjacent zone by a flow zone,
- ii) protein A, which is affixed to an electromagnetic radiation absorbing or emitting label, is in the conjugate zone,
- iii) a heparin-platelet factor 4 complex is immobilized on the test line,
- iv) an antibody binding ligand capable of binding with the protein A is immobilized at the reference line, and
- b) a means for quantitatively measuring the electromagnetic radiation absorbed or emitted at the test line by the label affixed to protein A.
A point-of-care lateral flow immunoassay system for quantitatively determining the body fluid level of heparin-platelet factor 4 complex induced immunoglobulin antibodies in a patient, wherein the system comprises:
- a) a linear membrane of an inert, fibrous material capable of supporting movement of liquids by capillary flow, affixed to a supporting backing, wherein
- i) the membrane is zoned into a sample pad, a conjugate zone, a test line, a reference line, and a wicking pad, wherein each zone is separated from its adjacent zone by a flow zone,
- ii) protein A, which is affixed to an electromagnetic radiation absorbing or emitting label, is in the conjugate zone,
- iii) a heparin-platelet factor 4 complex is immobilized on the test line,
- iv) an antibody binding ligand capable of binding with the protein A is immobilized at the reference line, and
- b) a means for quantitatively measuring the electromagnetic radiation absorbed or emitted at the test line by the label affixed to protein A.
Dependencies are inferred from the claim text.