# US 2014/0155281 A1 · Method of assessing infection status > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155281 A1 - Document ID: US20140155281A1 - Status: Published application - Kind: A1 - Application number: 13/859,438 - Filed: 2013-04-09 - Published: 2014-06-05 - Earliest claimed: 2012-04-09 - Assignees: Medela Holding AG - Inventors: Foteini Hassiotou - Web page: https://patentgrep.com/patent/US20140155281A1 ## CPC - G01N 33/56972: {White blood cells} - G01N 33/569: for microorganisms, e.g. protozoa, bacteria, viruses - G01N 33/6854: {Immunoglobulins} - G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors} - G01N 2800/38: Pediatrics - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract The present invention relates to a method for assessing the infection status of a subject and in particular to a method for assessing the infection status of a subject by analysing the cellular and/or humoral composition of breastmilk from said subject. The invention has been developed primarily for use as a method for detecting infection in a breastfeeding mother and/or infant. ## Claims ### Claim 1 A method of assessing the infection status of a breastfeeding mother and/or of an infant being breastfed by said mother, said method comprising the steps of: a) analysing the composition of immunological markers in a breastmilk sample obtained from said breastfeeding mother; and b) comparing said composition with a reference, wherein a difference in the composition of immunological markers in said breastmilk sample when compared to said reference is indicative of a change in the infection status of said mother and/or said infant. ### Claim 2 A method of assessing the infection status of a breastfeeding mother and/or of an infant being breastfed by said mother, said method comprising the steps of: a) determining the proportion of immune cells (ICs) in a breastmilk sample obtained from said breastfeeding mother; and b) comparing said proportion of ICs with a reference, wherein an increase in the proportion of said ICs when compared to said reference indicates that said mother and/or said infant have an infection. ### Claim 3 A method of assessing the infection status of a breastfeeding mother and/or of an infant being breastfed by said mother, said method comprising the steps of: a) determining the relative proportions of an IC-type within the total IC population in breastmilk obtained from said breastfeeding mother to establish a IC-type profile of said breastmilk; and b) comparing said IC-type profile with a reference, wherein a relative change in the IC-type profile when compared to said reference indicates that said mother and/or said infant have an infection. ### Claim at position 4 4-8. (canceled) ### Claim 9 (depends on 1) The method of claim 1, wherein said reference is the composition of immunological markers in a breastmilk sample obtained from the same breastfeeding mother when said mother was healthy. ### Claim 10 (depends on 1) The method of claim 1, wherein said reference is the composition of immunological markers in breastmilk samples obtained from a population of breastfeeding mothers when said mothers were healthy. ### Claim 11 (depends on 1) The method of claim 1, wherein said immunological marker is selected from immune cells (IC), cytokines, and immunoglobulins. ### Claim 12 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the proportion of immune cells (ICs) in said breastmilk sample and wherein an increase in the proportion of said ICs when compared to said reference indicates that said mother and/or said infant have an infection. ### Claim 13 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the relative proportions of an immune cell (IC)-type within the total IC population in said breastmilk sample to establish an IC-type profile of said breastmilk sample and wherein a relative change in the IC-type profile when compared to said reference indicates that said mother and/or said infant have an infection. ### Claim 14 (depends on 5) The method of claim 5, wherein said ICs are leukocytes and wherein said proportion of leukocytes within said reference is between 0 and 2%. ### Claim 15 (depends on 5) The method of claim 5, wherein said increase in the proportion of said ICs is an increase in leukocytes of up to about 94% leukocytes of total breastmilk cells. ### Claim 16 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the cytokine level in said breastmilk sample. ### Claim 17 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the relative cytokine proportions in said breastmilk sample to establish a cytokine profile of said breastmilk sample. ### Claim 18 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the immunoglobulin level in said breastmilk sample. ### Claim 19 (depends on 1) The method of claim 1, wherein analysing the composition of immunological markers comprises determining the relative immunoglobulin proportions in said breastmilk sample to establish an immunoglobulin profile of said breastmilk sample. ### Claim 20 (depends on 1) The method of claim 1, wherein said difference is indicative of a change in the infection status of said mother and said infant. ### Claim 21 (depends on 1) The method of claim 1, wherein said difference is indicative of a change in the infection status of said mother only. ### Claim 22 (depends on 1) The method of claim 1, wherein said difference is indicative of a change in the infection status of said infant only.