EP-4073513-B1 - INFECTION ANALYSIS APPARATUS AND METHOD

Inventors

• KARAKULLUKÇU, Asiye

Dates

Publication Date

20260506

Application Date

20201211

Claims (14)

1. A system for detecting an infection with a bacterial pathogen strain, the system comprising: an electrode functionalised with the surface proteins of the bacterial pathogen strain; and a controller configured to communicate with the electrode to perform an electrochemical test of a biological sample from a subject, the biological sample deposited on the electrode, wherein the electrochemical test measures a binding energy of one or more biomarkers in the biological sample with the surface proteins of the bacterial pathogen strain functionalised on the electrode to determine whether the subject has an immune response to the bacterial pathogen strain indicative of an infection with the bacterial pathogen strain, wherein the controller is an electronic device, wherein the biomarkers comprise one or more of C3b, IgG1 and/or IgG3; and wherein the system is configured to determine whether the subject has an infection with the bacteria based on a determination that the binding energy exceeds a threshold value.
2. The system of claim 1, wherein the surface proteins of the bacterial pathogen strain comprise complement binding proteins, C3b binding proteins, immunoglobulin binding proteins; CR1 binding proteins; FcR binding proteins; extracellular complement binding proteins; Protein A, Immunoglobulin-binding protein 1; membrane proteins; and outer membrane proteins.
3. The system of claim 1 or claim 2, wherein the biological sample is selected from the group consisting of: a blood sample; a urine sample; an endotracheal aspiration sample; a bronchoalveolar lavage sample; and other extracellular fluid sample of the person.
4. The system of any one of claims 1 to 3, wherein the surface proteins functionalised on the electrode are immobilized on a surface of the electrode
5. The system of claim 4, wherein the immobilized surface proteins comprise a coating on the surface of the electrode.
6. The system of any one of claims 3 to 5, wherein the electrode comprises a plurality of conductive elements and wherein the controller is configured to perform the electrochemical test by measuring the binding energy of the one or more biomarkers in the blood sample with the surface proteins functionalised on the electrode by applying a voltage differential across at least some of the plurality of conductive elements.
7. The system of any one of claims 1 to 6, wherein the controller is configured to select the threshold value based on the infection being detected.
8. The system of any one of claims 1 to 7, wherein the threshold value is between -3.4 V and 3.4 V.
9. A method of detecting an infection with a bacterial pathogenic strain, the method comprising: functionalising an electrode with the surface proteins of the bacterial pathogenic strain; and performing an electrochemical test of a biological sample from a subject, the biological sample deposited on the electrode, wherein the electrochemical test comprises measuring a binding energy of one or more biomarkers in the biological sample with the surface proteins functionalised on the electrode to determine whether the subject has an immune response to the pathogenic strain indicative of an infection with the bacterial pathogenic strain; wherein the biomarkers comprise one or more of C3b, IgG1 and/or IgG3; and wherein the method comprises determining whether the subject has an infection with the bacteria based on a determination that the binding energy exceeds a threshold value.
10. The method of claim 9, wherein functionalising the electrode comprises immobilizing the surface proteins onto a surface of the electrode.
11. The method of claim 10, wherein functionalising the electrode comprises coating the surface of the electrode with the surface proteins.
12. The method of any one of claims 9 to 11, wherein the threshold value is selected based on the infection being detected.
13. The method of any one of claims 9 to 12, wherein the threshold value is between -3.4 V and 3.4 V.
14. The method of any one of claims 9 to 13 wherein the electrode comprises a plurality of conductive elements and wherein the method comprises performing an electrochemical test by measuring a binding energy of the one or more biomarkers in a blood sample with the surface proteins functionalised on the electrode by applying a voltage differential across at least some of the plurality of conductive elements.

Description

Field of the invention The present invention relates to the field of infection analysis. In particular, embodiments of the invention relate to analysis of a biological sample, for example a blood sample, from a person to determine whether an infection, such as a bacterial infection, is present or not in the body of the person. Background Infections are caused by foreign agents in a body of an organism, for example a human person or patient, and can result in illness or disease of the organism. Pathogens, e.g. pathogenic bacteria provide one of the ways in which infections can be spread. Infections can be characterised by the pathogen that cause them, which may be a specific pathogenic strain, for example a bacterial strain. Evidence of the infection can be present in the blood, urine, or other parts of the human body. Detecting such infections in an organism, for example a human patient, from a biological sample, (e.g. a blood sample or urine sample) can be useful for diagnosis and subsequent treatment of the infection to prevent or alleviate the illness or disease. Once it is known that an infection is present in the patient, treatments such as antibiotics can be used to cure the infection. Commercial methods of determining whether a patient has an infection, e.g. a bacterial infection, entail first taking a sample of the patient's blood, urine, tissue, or body fluids from the suspected infected area. The sample is then cultured to grow the pathogen, e.g. bacteria, and subsequently identify the pathogen strain, e.g. pathogenic bacteria, in order to diagnose the infection. This is a time consuming process, resulting in long waiting periods to determine whether a patient has an infection or not. The longer a patient is waiting without a determination, the more chance an infection has to spread. There is therefore a desire to obtain a quick determination of infection to stop it spreading and to cure a patient as soon as possible. US 2017/108493 and WO 2006/109311 describe systems and methods for detecting infection of a pathogen. Summary Aspects of the invention are set out in the independent claims and preferred features are set out in the dependent claims. Hereinafter aspects and embodiments are aspects and embodiments of the invention only if they fall within the scope of the claims. According to a first aspect there is provided a system for detecting an infection with a bacterial pathogen strain, the system comprising: an electrode functionalised with the surface proteins of the bacterial pathogen strain and a controller configured to communicate with the electrode to perform an electrochemical test of a biological sample from a subject, the biological sample deposited on the electrode, wherein the electrochemical test measures a binding energy of one or more biomarkers in the biological sample with the surface proteins of the bacterial pathogen strain functionalised on the electrode to determine whether the subject has an immune response to the bacterial pathogen strain indicative of an infection with the bacterial pathogen strain wherein the controller is an electronic device, wherein the biomarkers comprise one or more of C3b, IgG1 and/or IgG3; and wherein the system is configured to determine whether the subject has an infection with the bacteria based on a determination that the binding energy exceeds a threshold value. Optionally, the subject is a patient. Optionally, the biological sample is a blood sample. In some embodiments, there is provided a system for detecting an infection caused by a strain of bacteria, the system comprising: an electrode functionalised with proteins isolated from a cell wall of a bacteria of the bacterial strain; and a controller configured to communicate with the electrode to perform an electrochemical test of a blood sample from a subject, the blood sample deposited on the electrode, wherein the electrochemical test measures a binding energy of one or more biomarkers in the blood sample with the proteins functionalised on the electrode to determine whether the subject has or has had a response to the strain of bacteria indicative of an infection caused by the strain of bacteria. Optionally, the subject is a patient. Optionally the response is an immune response to the strain of bacteria indicative of an infection caused by the strain of bacteria. In some embodiments, there is provided a system for detecting an infection caused by a strain of bacteria, the system comprising: an electrode functionalised with surface proteins isolated from a cell wall of a bacteria of the bacterial strain; and a controller configured to communicate with the electrode to perform an electrochemical test of a blood sample from a patient, the blood sample deposited on the electrode, wherein the electrochemical test measures a binding energy of one or more biomarkers, in the blood sample with the surface proteins functionalised on the electrode to determine whether the patient has or has had an