ASSAY FOR DISTINGUISHING BETWEEN SEPSIS AND SYSTEMIC INFLAMMATORY RESPONSE SYNDROME

• US 20200131574A1
• Filed: 09/29/2017
• Published: 04/30/2020
• Est. Priority Date: 09/29/2016
• Status: Abandoned Application

• Current Assignee: Cardiff University
• Original Assignee: Secretary of State for Health
• Inventors: HALL, Judith, SZAKMANY, Tamas, SHAH, Sanjoy, KEMPSELL, Karen, BALL, Graham
• Application Number:
  US16/335,830
• Publication Number:
  US 20200131574A1
• Time in Patent Office: Days
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/112 Disease subtyping, staging or classification
• CPC Class Codes: C12Q 2600/118 Prognosis of disease development
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: C12Q 2600/16 Primer sets for multiplex assays
• CPC Class Codes: G01N 2030/8813 biological materials
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders SLE G01N2800/104
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 2800/7095 Inflammation
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9

Abstract

There is provided a method for distinguishing between sepsis and systemic inflammatory response syndrome (SIRS) in a patient, comprising: (i) determining the amount of one or more biomarker for sepsis, and one or more biomarker for SIRS in a sample obtained from a patient, wherein the one or more biomarker for sepsis is selected from the group consisting of: ITGB3, ITGA2B, MYL9, LCN2, TREML1, LCN15, CMTMS, PPBP, and PF4; and the one or more biomarker for SIRS is selected from the group consisting of: PLA2G7, ARHGEF10L, MYCL, TGFBI, and GPR124, (ii) comparing the amount of the one or more biomarker for sepsis determined in said sample in (i) to a corresponding reference value representative of a healthy individual, (iii) comparing the amount of the one or more biomarker for SIRS determined in said sample in (i) to a corresponding reference value representative of a healthy individual; wherein the patient is diagnosed as having sepsis, when an increase is observed in the one or more biomarker for sepsis, and no increase is observed in the one or more biomarker for SIRS, in the sample obtained from the patient relative to the corresponding reference value; and wherein the patient is diagnosed as having SIRS, when an increase is observed in the one or more biomarker for SIRS, and no increase is observed in the one or more biomarker for sepsis, in the sample obtained from the patient relative to the corresponding reference value.

Claims

1-13. -13. (canceled)

14. A method for diagnosing whether a patient has a systemic inflammatory condition, comprising:

(i) determining the amount of FAM20A and OLAH in a sample obtained from a patient,

(ii) comparing the amount of FAM20A determined in said sample in (i) to a corresponding reference value representative of a healthy individual,

(iii) comparing the amount of OLAH determined in said sample in (i) to a corresponding reference value representative of a healthy individual;

wherein the patient is diagnosed as having a systemic inflammatory condition, when an increase is observed in FAM20A and/or OLAH in the sample obtained from the patient relative to the corresponding reference value; and

wherein the patient is diagnosed as not having a systemic inflammatory condition, when no increase is observed in FAM20A and OLAH, in the sample obtained from the patient relative to the corresponding reference value.

39. The method according to claim 14,

wherein the sample is a sample of blood, cerebral spinal fluid, cells, a cellular extract, a tissue specimen, or a tissue biopsy, or a combination thereof.

40. The method according to claim 39, wherein the blood sample is a sample of whole blood, purified peripheral blood leukocytes or cell type sorted leukocytes.

41. The method according to claim 14, wherein the method comprises determining the amount of FAM20A and OLAH at the protein level.

42. The method according to claim 41, wherein the amount of FAM20A is determined using an antibody specific for FAM20A, and the amount of OLAH is determined using an antibody specific for OLAH.

43. The method according to claim 14, wherein the method comprises determining the amount of FAM20A and OLAH at the nucleic acid level.

44. The method according to claim 43, wherein the amount of FAM20A is determined using an oligonucleotide specific for FAM20A, and the amount of OLAH is determined using an oligonucleotide specific for OLAH.

49. The method according to claim 44, wherein an oligonucleotide specific for FAM20A comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO:

94, 95, 96 or 97, preferably SEQ ID NO;

94 or 95;

or

wherein an oligonucleotide specific for FAM20A comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO;

424 or 427.

50. The method according to claim 43, wherein an oligonucleotide specific for OLAH comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO:

146, 147, 148, or 149, preferably SEQ ID NO;

146;

or

wherein an oligonucleotide specific for OLAH comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO;

430 or 433.

51. The method according to claim 44, wherein an oligonucleotide specific for OLAH comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO:

146, 147, 148, or 149, preferably SEQ ID NO;

146;

or

wherein an oligonucleotide specific for OLAH comprises or is complementary to a nucleic acid sequence having at least 80% sequence identity to the nucleic acid sequence of SEQ ID NO;

430 or 433.

15-38. -38. (canceled)

45-48. -48. (canceled)