Method for aiding differential diagnosis of stroke

Patent metadata

Field	Value
Publication number	US-10753948-B2
Application number	US-201414895724-A
Country	US
Kind code	B2
Filing date	Jun 4, 2014
Priority date	Jun 4, 2013
Publication date	Aug 25, 2020
Grant date	Aug 25, 2020

Abstract

The present invention provides a method of aiding the differential diagnosis of haemorrhagic stroke, ischemic stroke and a transient ischemic attack in a patient who has suffered or is suffering a stroke. The method comprises: (i) determining the concentration of the biomarkers VCAM-1, GFAP and CRP in an ex vivo sample obtained from the patient; and (ii) establishing the statistical significance of the concentration of the biomarkers. Optionally, the method further comprises steps of (iii) determining the concentration of the biomarkers IL-6 and sTNFR1 in an ex vivo sample obtained from the patient; (iv) determining the gender of the patient; and (v) establishing the statistical significance of the concentration of the five biomarkers, in conjunction with the patient's gender. The present invention also provides substrates comprising probes for VCAM-1, GFAP and CRP for use in a method for aiding the differential diagnosis of stroke.

First claim

The invention claimed is:

1. An assay for determining a concentration of biomarkers consisting of VCAM-1, GFAP and CRP in an ex vivo sample obtained from a patient who has suffered or is suffering a stroke and is in need of diagnosis of haemorrhagic stroke, ischemic stroke or transient ischemic attack, comprising
i) contacting the ex vivo sample with probes specific for VCAM-1, GFAP and CRP, wherein each probe binds specifically to VCAM-1, GFAP or CRP;
ii) carrying out a quantitative immunoassay to detect the concentration of the biomarkers present in the ex vivo sample and obtain a concentration value, wherein the probes specific for the biomarkers are present on the surface of a substrate;
iii) inputting the concentration value of each of the biomarkers present in the ex vivo sample of the biomarkers into a statistical algorithm or algorithms to produce an output value that correlates with a differential diagnosis of haemorrhagic stroke, ischemic stroke or transient ischaemic attack; and
iv) diagnosing haemorrhagic stroke, ischemic stroke or transient ischaemic attack based on the output value from the statistical algorithm or algorithms;
v) administering appropriate treatment based on the diagnosis of haemorrhagic stroke, wherein the patient is administered treatment in the form of surgery to repair one or more damaged blood vessels.

2. An assay according to claim 1 , wherein the statistical algorithm includes a logistic regression equation.

3. An assay according to claim 1 , wherein the ex vivo sample is a blood, serum or plasma sample.

4. An assay for determining a concentration of biomarkers consisting of VCAM-1, GFAP and CRP in an ex vivo sample obtained from a patient who has suffered or is suffering a stroke and is in need of diagnosis of haemorrhagic stroke, ischemic stroke or transient ischemic attack, comprising
i) contacting the ex vivo sample with probes specific for VCAM-1, GFAP and CRP, wherein each probe binds specifically to VCAM-1, GFAP or CRP;
ii) carrying out a quantitative immunoassay to detect the concentration of the biomarkers present in the ex vivo sample and obtain a concentration value, wherein the probes specific for the biomarkers are present on the surface of a substrate;
iii) inputting the concentration value of each of the biomarkers present in the ex vivo sample of the biomarkers into a statistical algorithm or algorithms to produce an output value that correlates with a differential diagnosis of haemorrhagic stroke, ischemic stroke or transient ischaemic attack; and
iv) diagnosing haemorrhagic stroke, ischemic stroke or transient ischaemic attack based on the output value from the statistical algorithm or algorithms
v) administering appropriate treatment based on the diagnosis of ischemic stroke, wherein the patient is administered a treatment to break-down clots.

5. An assay according to claim 4 , wherein the statistical algorithm includes a logistic regression equation.

6. An assay according to claim 4 , wherein the ex vivo sample is a blood, serum or plasma sample.

7. An assay according to claim 4 , wherein the treatment to break-down clots is thrombolytic therapy.

8. An assay for determining a concentration of biomarkers consisting of VCAM-1, GFAP and CRP in an ex vivo sample obtained from a patient who has suffered or is suffering a stroke and is in need of diagnosis of haemorrhagic stroke, ischemic stroke or transient ischemic attack, comprising
i) contacting the ex vivo sample with probes specific for VCAM-1, GFAP and CRP, wherein each probe binds specifically to VCAM-1, GFAP or CRP;
ii) carrying out a quantitative immunoassay to detect the concentration of the biomarkers present in the ex vivo sample and obtain a concentration value, wherein the probes specific for the biomarkers are present on the surface of a substrate;
iii) inputting the concentration value of each of the biomarkers present in the ex vivo sample of the biomarkers into a statistical algorithm or algorithms to produce an output value that correlates with a differential diagnosis of haemorrhagic stroke, ischemic stroke or transient ischaemic attack; and
iv) diagnosing haemorrhagic stroke, ischemic stroke or transient ischaemic attack based on the output value from the statistical algorithm or algorithms
v) administering appropriate treatment based on the diagnosis of transient ischaemic attack, wherein the patient is administered treatment in the form of one or more blood thinners.

9. An assay according to claim 8 , wherein the statistical algorithm includes a logistic regression equation.

10. An assay according to claim 8 , wherein the ex vivo sample is a blood, serum or plasma sample.

Assignees

• Randox Laboratories Ltd

Inventors

• Mcconnell Ivan
• Lamont John
• Fitzgerald Peter
• Makris Konstantinos

Classifications

• G01N2333/70503

  Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3 · CPC title

• G01N2333/7151

  for tumor necrosis factor [TNF]; for lymphotoxin [LT] · CPC title

• G01N2333/4737

  C-reactive protein · CPC title

• G01N33/6893 Primary

  related to diseases not provided for elsewhere · CPC title

• G01N2800/2871

  Cerebrovascular disorders, e.g. stroke, cerebral infarct, cerebral haemorrhage, transient ischemic event · CPC title