The invention relates to methods for detecting the presence or absence of an analyte in a sample. The invention also relates to devices for detecting the presence or absence of an analyte in a sample. In addition, the invention relates to analyte detection kits and systems.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
An electronic assay device and a method of detecting the presence or absence of an analyte in a sample using an electronic assay device are provided. The electronic assay device is configured to output an electronic signal indicative of the presence of an analyte in a sample. The electronic assay device comprises a sample receiving region, a detection reagent comprising a catalytic agent, capture molecules, a test region, and a battery configured to be activated by contact with a liquid. The test region comprises an electrode assembly and a test line configured to bind to the capture molecules. A sequence of potentials is applied to the electrode assembly upon activation of the battery. A first potential is applied to the electrode assembly to produce hydrogen peroxide in the test region. A second potential is applied to the electrode assembly to reduce oxidised indicator molecules, generating a charge transfer.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
Method for detecting a urinary tract infection (UTI) in a subject comprising determining levels of one or more biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject. The determined levels may then be compared with a threshold level, wherein increased levels of at least one of the biomarkers in the urine sample relative to the threshold level is indicative of the presence of a urinary tract infection. Methods for monitoring a UTI and monitoring treatment of a UTI are also provided as are companion systems or test kits.
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A lateral flow device for analysing a sample of liquid has a first lateral flow strip configured to respond to a first volume of sample and a second lateral flow strip configured to respond to a second volume of the sample, wherein the second volume is greater than the first volume. The lateral flow device comprises a first well configured to receive the first volume of the sample and a second well configured to receive the second volume of the sample. Each well has a flow restriction outlet located adjacent its lateral flow strip. The lateral flow device comprises a pre-actuation configuration and an actuated configuration. The first and second flow restriction outlets are configured such that, in use, in the pre-actuation configuration, a first surface tension of the first volume of the sample within the first well prevents the first volume of the sample passing through the first flow restriction outlet and a second surface tension of the second volume of the sample within the second well prevents the second volume of the sample passing through the second flow restriction outlet. In the actuated configuration, (a) the first flow restriction outlet is located sufficiently proximate the first lateral flow strip such that the first volume of the sample makes contact with the first lateral flow strip and is drawn along the first lateral flow strip thereby overcoming the first surface tension; and (b) the second flow restriction outlet is located sufficiently proximate the second lateral flow strip such that the second volume of the sample makes contact with the second lateral flow strip and is drawn along the second lateral flow strip thereby overcoming the second surface tension.
A method for predicting sepsis or diagnosing systemic inflammatory response syndrome (SIRS) and/or sepsis in a subject comprises determining levels of at least three markers selected from CCL23, A1AT, CRP, sICAM, PLA2, IL-6, procalcitonin, MMP8, TNFalpha, AcPGP, enzymatic MMP activity, TIMP1, sRAGE and desmosine in a sample taken from the subject. The combined levels of the at least three markers are used to predict or diagnose SIRS and/or sepsis. The methods may be performed on a subject with SIRS and which is used to identify an infection in the subject. A preferred panel of markers includes CCL23, A1AT, sICAM, sICAM/VCAM-1 and CRP. Corresponding products, methods of treatment and medical uses are provided.
Provided are methods of analysing markers of eosinophil levels and/or markers of neutrophil levels in a blood sample from a patient suffering from an exacerbation of inflammation of a respiratory condition to determine the levels of eosinophils and/or neutrophils respectively. The methods may involve selecting an appropriate treatment. Systems and kits for performing the analysis are also provided.
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
G01N 33/573 - Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
G01N 33/88 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving prostaglandins
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
A lateral flow device for analysing a sample of liquid has a first lateral flow strip configured to respond to a first volume of sample and a second lateral flow strip configured to respond to a second volume of the sample, wherein the second volume is greater than the first volume. The lateral flow device comprises a first well configured to receive the first volume of the sample and a second well configured to receive the second volume of the sample. Each well has a flow restriction outlet located adjacent its lateral flow strip. The lateral flow device comprises a pre-actuation configuration and an actuated configuration. The first and second flow restriction outlets are configured such that, in use, in the pre-actuation configuration, a first surface tension of the first volume of the sample within the first well prevents the first volume of the sample passing through the first flow restriction outlet and a second surface tension of the second volume of the sample within the second well prevents the second volume of the sample passing through the second flow restriction outlet. In the actuated configuration, (a) the first flow restriction outlet is located sufficiently proximate the first lateral flow strip such that the first volume of the sample makes contact with the first lateral flow strip and is drawn along the first lateral flow strip thereby overcoming the first surface tension; and (b) the second flow restriction outlet is located sufficiently proximate the second lateral flow strip such that the second volume of the sample makes contact with the second lateral flow strip and is drawn along the second lateral flow strip thereby overcoming the second surface tension.
The invention provides a sialidase enzyme activity detection kit or device comprising:
(i) an indicator molecule comprising a sialylated peptide and a capture site;
(ii) a capture zone comprising capture molecules; and
(iii) binding molecules capable of binding to the de-sialylated derivative of the indicator molecule. Also provided are methods of using the kits or devices, as well as specific indicator molecules and specific binding molecules.
The present invention relates to detecting cleavage activity of an enzyme. The various aspects of the invention include an enzyme detection device, kit, method and use for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. The invention also relates to indicator and binding molecules useful for carrying out the invention. The enzyme substrate contains a hidden binding site which is only revealed upon cleavage by the enzyme.
Provided are methods of analysing markers of eosinophil levels and/or markers of neutrophil levels in a blood sample from a patient suffering from an exacerbation of inflammation of a respiratory condition to determine the levels of eosinophils and/or neutrophils respectively. The methods may involve selecting an appropriate treatment. Systems and kits for performing the analysis are also provided.
Methods for monitoring inflammation status of a subject comprise determining levels of at least one neutrophil activation marker, or at least three markers, in urine samples taken from the subject at multiple time points, wherein increased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample are indicative of or predictive of an exacerbation of inflammation and/or wherein decreased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample following an increase are indicative or predictive of recovery from, or successful treatment of, an exacerbation of inflammation. Corresponding systems, test kits and computer programs are provided.
The invention provides a sialidase enzyme activity detection kit or device comprising: (i) an indicator molecule comprising a sialylated peptide and a capture site; (ii) a capture zone comprising capture molecules; and (iii) binding molecules capable of binding to the de-sialylated derivative of the indicator molecule. Also provided are methods of using the kits or devices, as well as specific indicator molecules and specific binding molecules.
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
The invention provides a sialidase enzyme activity detection kit or device comprising: (i) an indicator molecule comprising a sialylated peptide and a capture site; (ii) a capture zone comprising capture molecules; and (iii) binding molecules capable of binding to the de-sialylated derivative of the indicator molecule. Also provided are methods of using the kits or devices, as well as specific indicator molecules and specific binding molecules.
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
Methods for monitoring lung inflammation status of a subject suffering from a respiratory disorder comprise determining levels of at least three markers in urine samples taken from the subject at multiple time points, wherein increased levels of at least one of the markers in a urine sample is indicative of or predictive of a pulmonary exacerbation and/or wherein decreased levels of at least one of the markers in a urine sample following an increase are indicative or predictive of recovery from, or successful treatment of, a pulmonary exacerbation, wherein at least one of the markers is selected from RNASE3, Periostin, Siglec 8, chitinase-3-like protein (C3L1) and cathepsin B. Corresponding systems, test kits and computer programs are provided.
Method for detecting a urinary tract infection (UTI) in a subject comprising determining levels of one or more biomarkers selected from MMP8, HNE,Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6),interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject. The determined levels may then be compared with a threshold level, wherein increased levels of at least one of the biomarkers in the urine sample relative to the threshold level is indicative of the presence of a urinary tract infection. Methods for monitoring a UTI and monitoring treatment of a UTI are also provided as are companion systems or test kits.
A method for predicting sepsis or diagnosing systemic inflammatory response syndrome (SIRS) and/or sepsis in a subject comprises determining levels of at least three markers selected from CCL23, A1AT, CRP, sICAM, PLA2, IL-6, procalcitonin, MMP8, TNFalpha, AcPGP, enzymatic MMP activity, TIMP1, sRAGE and desmosine in a sample taken from the subject. The combined levels of the at least three markers are used to predict or diagnose SIRS and/or sepsis. The methods may be performed on a subject with SIRS and which is used to identify an infection in the subject. A preferred panel of markers includes CCL23, A1AT, sICAM, slCAM/VCAM-1 and CRP. Corresponding products, methods of treatment and medical uses are provided.
A diagnostic test apparatus comprises: an elongate housing defining a test strip holder containing a lateral flow test strip; a fluid sampling chamber provided with an opening connecting the fluid sampling chamber with the test strip holder; a viewing window in the elongate housing allowing reading of one or more portions of the lateral flow test strip; and a connector configured to couple the diagnostic test apparatus to a bulk source of fluid. The apparatus may be included in a kit of parts. The apparatus is useful for detecting peritonitis. The bulk source of fluid may be peritoneal dialysate. Various markers may be determined in the bulk source of fluid such as MMP8, IL-6, HNE, MMP2, MMP9, TIMP1, TIMP2, NGAL, A1AT, desmosine, fibrinogen, IL-8, calprotectin, fMLP, IL1 b, cystatin C, HSA, RBP4, SPD, MPO, sICAM and TNFa. Detection of the markers to indicate peritonitis may also inform treatment choices.
The present invention relates to detecting cleavage activity of an enzyme. The various aspects of the invention include an enzyme detection device, kit, method and use for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. The invention also relates to indicator and binding molecules useful for carrying out the invention. The enzyme substrate contains a hidden binding site which is only revealed upon cleavage by the enzyme.
Non-enzymatic approaches to measuring glucose are based on the direct oxidation of glucose using unmodified copper metal electrodes. A potential is applied to a copper measurement/working electrode, which potential is monitored by a separate reference electrode and the current within the system is balanced with a counter electrode. The presence of the ionized glucose in the sample can then be determined electrochemically. Disclosed herein are methods, devices, and test systems which utilise this novel approach.
Methods are provided for determining the presence of an analyte present in a liquid sample involving: contacting the liquid sample with a predetermined amount of an analogue of the analyte and an excess of a first binding moiety, wherein the first binding moiety is capable of binding each of the analyte and the analogue independently; contacting the mixture with a second binding moiety; and determining the level of a signal indicative of the presence of the analogue-first binding moiety complex bound to the second binding moiety, wherein if the level of the signal determined is lower than the level of a maximum signal determined when no analyte is present, then analyte is present in the sample. Corresponding kits are also provided.
Methods for monitoring inflammation status of a subject comprise determining levels of at least one neutrophil activation marker, or at least three markers, in urine samples taken from the subject at multiple time points, wherein increased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample are indicative of or predictive of an exacerbation of inflammation and/or wherein decreased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample following an increase are indicative or predictive of recovery from, or successful treatment of, an exacerbation of inflammation. Corresponding systems, test kits and computer programs are provided.
Methods for monitoring inflammation status of a subject comprise determining levels of at least one neutrophil activation marker, or at least three markers, in urine samples taken from the subject at multiple time points, wherein increased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample are indicative of or predictive of an exacerbation of inflammation and/or wherein decreased levels of the at least one neutrophil activation marker, or at least one of the markers, in a urine sample following an increase are indicative or predictive of recovery from, or successful treatment of, an exacerbation of inflammation. Corresponding systems, test kits and computer programs are provided.
Described herein is an enzyme detection device for use in the detection of enzyme activity in a test sample. Also provided are indicator molecules for use in the detection of enzyme activity, particularly enzyme cleavage activity, in a test sample, and to methods for detecting the presence of enzyme activity.
Described herein is an enzyme detection device for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. Also provided are methods for detecting enzyme activity, in particular the presence in a test sample of an enzyme capable of cleaving a substrate, and methods for determining the level or amount of such an enzyme in a test sample.
A polypeptide comprising a chromogenic amino acid. The chromogenic amino acid is flanked by at least one amino acid to the N and C termini thereof. The amine group of the chromogenic amino acid has a pKa of less than 5. The chromogenic amino acid is capable of reacting with a conjugated aldehyde. The polypeptide comprises a target sequence for a target protease which is capable of cleaving the peptide bond comprising the amino group of the chromogenic amino acid.
The present invention relates to indicator molecules containing multiple cleavage sites for use in detecting enzyme cleavage activity. The invention also relates to various applications of these indicator molecules, for example in enzyme detection devices, particularly although not exclusively, devices for use in the detection of enzyme activity in a test sample. The invention also relates to using the indicator molecules in methods for detecting the presence of enzyme activity in a test sample.
The present invention relates to detecting cleavage activity of an enzyme. The various aspects of the invention include an enzyme detection device, kit, method and use for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. The invention also relates to indicator and binding molecules useful for carrying out the invention. The enzyme substrate contains a hidden binding site which is only revealed upon cleavage by the enzyme.
The present invention relates to detecting cleavage activity of an enzyme. The various aspects of the invention include an enzyme detection device, kit, method and use for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. The invention also relates to indicator and binding molecules useful for carrying out the invention. The enzyme substrate contains a hidden binding site which is only revealed upon cleavage by the enzyme.
The present invention relates to an enzyme detection device for use in the detection of enzyme activity in a test sample. The invention also relates to indicator molecules for use in the detection of enzyme activity, particularly enzyme cleavage activity, in a test sample, and to methods for detecting the presence of enzyme activity.
The present invention relates to an enzyme detection device for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate. The invention also relates to methods for detecting enzyme activity, in particular the presence in a test sample of an enzyme capable of cleaving a substrate, and methods for determining the level or amount of such an enzyme in a test sample.
An enzyme detection device (1) for detecting the presence, in a sample, of an enzyme capable of modifying a provided substrate (10). The device (1) comprises a substrate which has a modification region (14) that is sensitive to modification by the enzyme from an unmodified state to a modified state. The device (1) further comprises a substrate recognition molecule (16) which binds the modification region (14) in either the modified or the unmodified state. The modification region 14 of the substrate is preferentially bound by the substrate recognition molecule (16) as compared with the enzyme when mixed. The device further comprises a detectable label (18) coupled to the substrate recognition molecule (17).
A peptide clearing agent is provided for clearance of a conjugate of an enzyme and a binding molecule which binds specifically at a target location from a non-target location in a subject. The peptide clearing agent binds the active site of the enzyme. The peptide also binds to the asialoglycoprotein receptor expressed by hepatic cells to facilitate clearance through the liver. The peptide may be glycosylated to facilitate clearance through the liver by binding to hepatic cells expressing an asialoglycoprotein receptor. Typically, the peptide prevents or inhibits enzyme activity upon binding to the enzyme and is not substantially modified by the enzyme activity. The peptide may be based upon the dipeptide amino-naphthoic acid (ANA) - glutamate (GIu) and may comprise the amino acid sequence serine (Ser) - Alanine (Ala) - amino-naphthoic acid (ANA) - glutamate (GIu). In such cases, the enzyme of interest is typically CPG2.
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
C07K 5/02 - Peptides having up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link
A docking station for use in combined imaging of a tissue wound and a test substrate comprising a sample from a tissue wound, the docking station comprises means for connecting the station to a processor which processes and stores the images. The docking station also incorporates means for receiving a test substrate comprising a sample from a tissue wound. The docking station also includes means for docking a sensor in the station, which sensor detects the light reflected from an illuminated tissue wound, such that an image of the tissue wound can be communicated from the station to the processor. The means for docking is arranged such that when the sensor is docked in the station and the test substrate is received by the docking station, the sensor is positioned to detect the intensity of reflected light from the test substrate and communicates the detected intensity of reflected light to the processor to thus permit combined imaging of the tissue wound and test substrate. An apparatus for use in combined imaging of a tissue wound and a test substrate comprising a sample from a tissue wound, comprises such a docking station together with a sensor which detects the light reflected from a tissue wound and test substrate when illuminated and a test substrate for receiving a sample from a tissue wound. A method of imaging a wound comprises directing light over a wavelength range of less than 50nm onto the wound (9). The light reflected from the wound (9) is detected with a sensor (5) that is sensitive to the intensity of the reflected light. The intensity of the reflected light is measured.
A polypeptide comprising a chromogenic amino acid. The chromogenic amino acid is flanked by at least one amino acid to the N and C termini thereof. The amine group of the chromogenic amino acid has a pKa of less than 5. The chromogenic amino acid is capable of reacting with a conjugated aldehyde. The polypeptide comprises a target sequence for a target protease which is capable of cleaving the peptide bond comprising the amino group of the chromogenic amino acid.
An enzyme detection device (1) for detecting the presence, in a sample, of an enzyme capable of modifying a provided substrate (10). The device (1) comprises a substrate which has a modification region (14) that is sensitive to modification by the enzyme from an unmodified state to a modified state. The device (1) further comprises a substrate recognition molecule (16) which binds the modification region (14) in either the modified or the unmodified state. The modification region 14 of the substrate is preferentially bound by the substrate recognition molecule (16) as compared with the enzyme when mixed. The device further comprises a detectable label (18) coupled to the substrate recognition molecule (17).
The invention relates to products and methods for detecting nitrate, nitrite or metabolites of nitric oxide in a sample. A nitrate detection product (1) for detecting nitrate in a sample comprises (i) a reaction zone (5) containing a reducing agent and adapted so as to receive the sample and contact it with the reducing agent in the presence of a source of iodide to produce a reaction product; and (ii) a detection zone (10) for presenting a signal in response to the detection of a component of the reaction product. A method of detecting nitrate in a sample comprises the steps of (i) contacting the sample with a reducing agent in the presence of a source of iodide in a reaction zone (5) to produce a reaction product; and (ii) presenting a signal in response to the detection of a component of the reaction product in a detection zone (10).
A protease detection product (1) for detecting a protease enzyme in a sample. The protease detection product (1) comprises a medium (2) providing a liquid flow path; a labelled component (6) located on the liquid flow path; a capture component (12) located downstream of the labelled component (6) and immobilisation means (8) for immobilising the intact labelled component. The labelled component (7) comprises a base element (8) connected to releasable element via a protease-sensitive linker peptide (9). The releasable element comprises a label (10). The capture component (12) is capable of binding the releasable element.
A method of detecting a protease in a sample. The method comprises providing an analyte degradable by the protease. The analyte is contacted with the sample. The degradation products of the analyte or the residual undegraded analyte is detected in a binding assay.
A binding assay product (1) for detecting the presence of an analyte in a sample comprising a labelling module (5), a label, a capture module (9) and a visualisation module (10). The labelling module (5) comprises a first binding component capable of binding the analyte. The label is connectable to the first binding component. The capture module (9) comprises a second binding component capable of binding the analyte. The visualisation module (10) is for detecting the first binding component connected to the label and bound to the second binding component via the analyte. The labelling module and the capture module comprise a fluid conducting medium in which the binding components are embedded. The labelling module (5), the capture module (9) and the visualisation module (10) together define a flow path along which the sample is capable of flowing.
An enzyme detection product (1) for detecting the presence of an enzyme in a sample. The product (1) comprises: a reaction zone (16) for receiving the sample; a visualisation zone (10) for presenting a signal in response to the detection of the activity of the enzyme; and a membrane (11). The membrane (11) is interposable between the reaction zone (16) and the visualisation zone (10) and prevents passage from the reaction zone (16) to the visualisation zone (10) the components having a size greater than a threshold size. The reaction zone (16) comprises a reactant capable of reacting with the enzyme in order to generate a reaction product having a size less than a threshold size.
A nucleic acid sequence encoding a decarboxylation enzyme E.G. PADl is used as a selectable marker in a recombinant organism. A weak acid is used as the selecting agent .
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