Method for diagnosis and/or prognosis of a septic syndrome

• US 20060127912A1
• Filed: 06/02/2004
• Published: 06/15/2006
• Est. Priority Date: 06/03/2003
• Status: Active Grant

• Current Assignee: Biomerieux B.V. (Compagnie Merieux Alliance SAS)
• Original Assignee: Biomerieux B.V. (Compagnie Merieux Alliance SAS)
• Inventors: Pachot, Alexandre
• Granted Patent: US 7,622,249 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/118 Prognosis of disease development
• CPC Class Codes: C12Q 2600/158 Expression markers

Abstract

The present invention relates to a method for diagnosing and/or predicting a septic syndrome, wherein: a. a biological sample from the patient is made available and biological material is extracted from the biological sample b. at least four specific reagents which are selected from the following specific reagents are made available: reagent which is specific for the target gene IL-10, reagent which is specific for the target gene TGFβ, reagent which is specific for the target gene HMG1, reagent which is specific for the target gene T-bet, reagent which is specific for the target gene IL-1β, reagent which is specific for the target gene TNFα and reagent which is specific for the target gene GATA-3 c. the expression of at least four target genes selected from: IL-10, TGFβ, HMG1, T-bet, IL-1β, TNFα and GATA-3 is determined. The present invention also relates to a kit for diagnosing and/or predicting a septic syndrome.

Claims

1. A method for diagnosing and/or predicting a septic syndrome,

wherein:

a. a biological sample from the patient is made available and biological material is extracted from the biological sample

b. at least four specific reagents which are selected from the following specific reagents are made available;

reagent which is specific for the target gene IL-10, reagent which is specific for the target gene TGFβ

, reagent which is specific for the target gene HMG1, reagent which is specific for the target gene T-bet, reagent which is specific for the target gene IL-1β

, reagent which is specific for the target gene TNFα and

reagent which is specific for the target gene GATA-3

c. the expression of at least four target genes selected from;

IL-10, TGFβ

, HMG1, T-bet, IL-1β

, TNFα and

GATA-3 is determined.

2. The method as claimed in claim 1, wherein the biological sample is a blood sample.

3. The method as claimed in claim 1, wherein the biological material is a nucleic acid.

4. The method as claimed in claim 1, wherein the reagent which is specific for IL-10 comprises at least one amplification primer which is specific for the target gene IL-10, the reagent which is specific for TGFβ

comprises at least one amplification primer which is specific for the target gene TGFβ

, the reagent which is specific for HMG1 comprises at least one amplification primer which is specific for the target gene HMG1, the reagent which is specific for T-bet comprises at least one amplification primer which is specific for the target gene T-bet, the reagent which is specific for IL-1β

comprises at least one amplification primer which is specific for the target gene IL-1β

, the reagent which is specific for TNFα

comprises at least one amplification primer which is specific for the target gene TNFα and

/or the reagent which is specific for GATA 3 comprises at least one amplification primer which is specific for the target gene GATA 3.

5. The method as claimed in claim 1, wherein the reagent which is specific for IL10 comprises at least one hybridization probe which is specific for the target gene IL-10, the reagent which is specific for TGFβ

comprises at least one hybridization probe which is specific for the target gene TGFβ

, the reagent which is specific for HMG1 comprises at least one hybridization probe which is specific for the target gene HMG1, the reagent which is specific for T-bet comprises at least one hybridization probe which is specific for the target gene T-bet, the reagent which is specific for IL-1β

comprises at least one hybridization probe which is specific for the target gene IL-1β

, the reagent which is specific for TNFα

comprises at least one hybridization probe which is specific for the target gene TNFα and

/or the reagent which is specific for GATA 3 comprises at least one hybridization probe which is specific for the target gene GATA 3.

6. A method for diagnosing and/or predicting a septic syndrome, wherein:

a. a biological sample from the patient is made available and biological material is extracted from the biological sample

b. at least one specific reagent which is selected from the following specific reagents is made available;

reagent which is specific for the IL-10 gene, reagent which is specific for the T-bet gene, and reagent which is specific for the GATA-3 gene

c. the expression of at least one target gene selected from;

IL-10, T-bet and GATA-3 is determined.

7. The method as claimed in claim 6, wherein the biological sample is a blood sample.

8. The method as claimed in claim 6, wherein the biological material is a nucleic acid.

9. The method as claimed in claim 6, wherein the reagent which is specific for IL10 comprises at least one amplification primer which is specific for the target gene IL-10, the reagent which is specific for T-bet comprises at least one amplification primer which is specific for the target gene T-bet and/or the reagent which is specific for GATA 3 comprises at least one amplification primer which is specific for the target gene GATA 3.

10. The method as claimed in claim 6, wherein the reagent which is specific for IL10 comprises at least one hybridization probe which is specific for the target gene IL-10, the reagent which is specific for T-bet comprises at least one hybridization probe which is specific for the target gene T-bet and/or the reagent which is specific for GATA 3 comprises at least one hybridization probe which is specific for the target gene GATA 3.

11. A kit for diagnosing and/or predicting a septic syndrome, comprising at least four specific reagents which are selected from the following specific reagents:

reagent which is specific for the IL-10 gene, reagent which is specific for the TGFβ

gene, reagent which is specific for the HMG1 gene, reagent which is specific for the T-bet gene, reagent which is specific for the IL-1β

gene, reagent which is specific for the TNFα

gene and reagent which is specific for the GATA-3 gene.

12. The kit as claimed in claim 11, wherein the reagent which is specific for IL10 comprises at least one amplification primer which is specific for the target gene IL-10, the reagent which is specific for TGFβ

comprises at least one amplification primer which is specific for the target gene TGFβ

, the reagent which is specific for HMG1 comprises at least one amplification primer which is specific for the target gene HMG1, the reagent which is specific for T-bet comprises at least one amplification primer which is specific for the target gene T-bet, the reagent which is specific for IL-1β

comprises at least one amplification primer which is specific for the target gene IL-1β

, the reagent which is specific for TNFα

comprises at least one amplification primer which is specific for the target gene TNFα and

/or the reagent which is specific for GATA 3 comprises at least one amplification primer which is specific for the target gene GATA 3.

13. The kit as claimed in claim 11, wherein the reagent which is specific for IL10 comprises at least one hybridization probe which is specific for the target gene IL-10, the reagent which is specific for TGFβ

comprises at least one hybridization probe which is specific for the target gene TGFβ

, the reagent which is specific for HMG1 comprises at least one hybridization probe which is specific for the target gene HMG1, the reagent which is specific for T-bet comprises at least one hybridization probe which is specific for the target gene T-bet, the reagent which is specific for IL-1β

comprises at least one hybridization probe which is specific for the target gene IL-1β

, the reagent which is specific for TNFα

comprises at least one hybridization probe which is specific for the target gene TNFα and

/or the reagent which is specific for GATA 3 comprises at least one hybridization probe which is specific for the target gene GATA 3.

14. A kit for diagnosing and/or predicting a septic syndrome, comprising at least one specific reagent which is selected from the following specific reagents:

reagent which is specific for the IL-10 gene, reagent which is specific for the T-bet gene and reagent which is specific for the GATA-3 gene.

15. The kit as claimed in claim 14, wherein the reagent which is specific for IL10 comprises at least one amplification primer which is specific for the target gene IL-10, the reagent which is specific for T-bet comprises at least one amplification primer which is specific for the target gene T-bet, and/or the reagent which is specific for GATA 3 comprises at least one amplification primer which is specific for the target gene GATA 3.

16. The kit as claimed in claim 14, wherein the reagent which is specific for IL10 comprises at least one hybridization probe which is specific for the target gene IL-10, the reagent which is specific for T-bet comprises at least one hybridization probe which is specific for the target gene T-bet, and/or the reagent which is specific for GATA 3 comprises at least one hybridization probe which is specific for the target gene GATA 3.

17. A method for diagnosing and/or predicting a septic syndrome, wherein:

a. a biological sample from the patient is made available and biological material is extracted from the biological sample

b. at least two specific reagents which are selected from the following specific reagents are made available;

reagent which is specific for the target gene IL-10, reagent which is specific for the target gene TGFβ

, reagent which is specific for the target gene HMG1, reagent which is specific for the target gene T-bet, reagent which is specific for the target gene IL-1β

, reagent which is specific for the target gene TNFα and

reagent which is specific for the target gene GATA-3

c. the expression of at least two target genes selected from;

IL-10, TGFβ

, HMG1, T-bet, IL-1β

, TNFα and

GATA-3 is determined in a single step.

18. A method for diagnosing and/or predicting a septic syndrome, wherein:

a. a biological sample from the patient is made available and the total RNA is extracted from the biological sample

b. at least one reagent which is specific for the HMG1 gene is made available

c. the expression of the mRNAs from the HMG1 gene is determined.