Diagnostic blood test to identify infants at risk for sepsis

• US 5,830,679 A
• Filed: 02/27/1997
• Issued: 11/03/1998
• Est. Priority Date: 03/01/1996
• Status: Expired due to Fees

• Current Assignee: New England Medical Center Hospitals, Inc.
• Original Assignee: New England Medical Center Hospitals, Inc.
• Inventors: Weinschenk, Nancy, Bianchi, Diana W.
• Primary Examiner(s): Spiegel, Carol A.
• Application Number:
  US08/807,578
• Time in Patent Office: 614 Days
• Field of Search: 435/7.24, 435/7.92, 435/973, 436/519, 436/548, 436/800, 436/811
• US Class Current: 435/7.24
• CPC Class Codes: G01N 33/56972 White blood cells
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/80 Fluorescent dyes, e.g. rhodamine
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

Disclosed is a method of diagnosing sepsis in a human infant. The method includes detecting an increase in the expression of leukocyte cell surface antigens in a blood sample from an infant at risk for developing sepsis.

Claims

1. A method for detecting sepsis in a human infant patient, said method comprising the steps of:

(a) obtaining a blood sample from a human infant patient born to a mother having at least one infant sepsis risk factor, or a human infant patient displaying at least one sign of infection;

(b) contacting leukocytes in the blood sample with a labelled antibody which specifically binds a cell surface antigen of said leukocytes, wherein said cell surface antigen is selected from the group consisting of CD25, CD69, CD11c, CD33, and CD66b;

(c) determining the percentage of said leukocytes which bind said labelled antibody; and

(d) comparing the percentage of leukocytes which bind said labelled antibody to the percentage of leukocytes which bind said labelled antibody in a blood sample from a non-septic human infant age-matched to said human infant patient,

wherein an increased percentage in the human infant patient compared to the non-septic human infant indicates sepsis in the human infant patient.

2. The method of claim 1, wherein said labelled antibody is a monoclonal antibody.

3. The method of claim 1, wherein said determining step comprises flow cytometry.

4. The method of claim 1, wherein red blood cells in said blood sample are lysed after contacting said blood sample with said labelled antibody without lysing said leukocytes.

5. The method of claim 1, wherein said leukocytes are treated with a fixative before determination of leukocytes with the labelled antibody bound on their surface.

6. The method of claim 1, wherein said contacting step further comprising contacting said blood sample with a second labelled antibody which specifically binds to a different said cell surface antigen, wherein the two labelled antibodies are labelled with different labels.

7. The method of claim 1 wherein the antibody is labelled with a fluorescent dye.

8. The method of claim 7 wherein the fluorescent dye is fluorescein isothiocyanate or phycoerythrin.