Abstract: An analyte testing system for quantifying the presence of an analyte in a speciment by lateral flow chromatography. The system comprises a test cassette (10) with a lateral flow chromatography and a mobile hand-held processor device (16) comprising a digital camera (16a), a source of light (16b) and a processor (16c), which software and hardware (16c) are configured to determine automatically the distance between camera and object and the measures of light in the region of interest of the lateral flow chromatography prior any retrieval of image data for further analysis and quantification of the visual signals.

Abstract: Kit and method for the microbiological determination of folate and folic acid in a whole blood sample and for the assessment of the folate status of an individual, comprising steps for complete lysis of erythrocytes (red blood cells) and release of folate species, as well as steps for release of lysosomal ?-glutamyl hydrolase from cells contained in the whole blood sample and/or addition of ?-glutamyl hydrolase and complete enzymatic hydrolysis of the ?-glutamyl chains of folypolyglutamate species, folytetraglutamates, folypentaglutamates and folyhexaglutamate, followed by a microbiological assay for comparative study of growth and metabolism in the absence and presence of various amounts of treated whole blood sample and/or folate calibrator to assess the folate status of an individual in comparison to the folate references.

Abstract: A specimen collecting system (10) with an elongated sampling utensil (100) for fecal matter and an integrated container for transport, preservation, and extraction of the collected sample. The system comprises an open-ended tubular structure (30) with a fitting hole at an intermediate position (50). The tubular structure can be tightly closed at both ends by screw caps (20, 40). The top cap (20) is integrally molded with or attached to a sampling utensil (100) that is inserted into the tubular structure (30) in the axial direction. The bottom cap (40) forms a liquid-tight distal chamber (32) with the tubular structure (30) and the sampling utensil (100) when inserted into the fitting hole, which is, therefore, capable of receiving a buffer solution. The elongated sampling utensil (100) has a fenestrated segment (110) with a sampling cavity (104) at its axial distal end and a cut-out member (106) at its forward end.

Abstract: An analyte testing system for quantifying the presence of an analyte in a specimen by immunochromatography. The system comprises a camera test card, depicting a test cassette (10) with an immunochromatography and a handheld processor device (16) comprising a digital camera (16a), a source of light (16b) and a processor (16c), which software and hardware (16c) are configured to make a pose estimation of camera and object and the measures of light in the region of interest of the immunochromatography. The system allows an automatic camera calibration and certification as a scanner for use in point-of-care diagnostics.

Abstract: Test kit, composition and a method of measuring vitamin D and its metabolites in a sample of bodily fluid from a subject, which sample contains vitamin D binding protein (DBP), comprising the steps of contacting said sample with megalin and/or a soluble fragment thereof under binding conditions to form a ternary complex containing DBP, a vitamin D metabolite and megalin or a fragment thereof; determining the amount of DBP bound by megalin; and relating the amount of megalin-bound DBP to the effective status of vitamin D in the circulation of said subject.

Abstract: A method for diagnosing histamine intolerance syndrome in a patient suspected of suffering from insufficient histamine inactivation activity. The diagnostic procedure involves spiking or administering of histamine labelled with a stable isotope. Samples (usually serum, plasma, urine) are taken after one or more predetermined periods of time and an aprotic solvent is added to remove proteins and organic salts. The amounts of isotopically labelled histamine in the samples and, if applicable, one or more isotopically labelled inactivation products of histamine are determined by hydrophilic interaction chromatography and mass spectrometry. The histamine inactivation activity can then be determined from the amounts and ratios of isotopically labelled histamine, imidazole acetic acid, and methylhistamine, and optionally methylimidazole acetic acid. Diagnosis is based on the comparison with the histamine inactivation found in healthy individuals.

Abstract: A method for quantitative determination of bioavailable L-tryptophan in faeces and a method of diagnosis whether a subject is suffering from impaired fructose absorption or from a lack of bioavailable tryptophan. The latter includes the localization of a previously hidden aetiology of decreased blood tryptophan levels and a method of in vitro diagnosis of the aetiology of gastrointestinal (IBD), Crohn's disease, depression symptoms, anxiety, insomnia, sleep disorders, dysphoric disorders. A kit of parts for determining the ratio of free L-tryptophan to blocked glycated tryptophan or fructosyl-tryptophan adduct for immediate treatment of these disorders by providingpatients with appropriate dietary recommendations or an intake of tryptophan that is not blocked or glycated in the acidic environment of the stomach or gastrointestinal tract.

Abstract: Method of determining therapeutic drug antibodies in a sample of bodily fluid of a subject receiving a medication containing a therapeutic drug antibodies against tumor necrosis factor alpha. The method is used in an lateral flow immunochromatographic test wherein the immunochromatographic bridging and binding in the test line comprises the use of an anti-idiotypic scFv fragment or Fab fragment fused to a carrier protein which is not involved in nor plays a role in the inherent or developed immune system. The fusion protein may contain human serum albumin, chicken ovalbumin, human haptoglobin or human alpha-1- antitrypsin. The immunological reaction is therefore not impaired, augmented or interfered by members of the complement system or by autoantibodies such as the rheumatoid factor. This is of particular importance and favorable when determining the concentration of tumor necrosis alpha blockers such as adalimumab or in-fliximab in serum or blood of patients.

Abstract: A method for measuring the presence of calprotectin (S100A8/A) heterodimer in a biological sample using a particle-enhanced turbidimetric immunoassay (PETIA) based on monoclonal antibodies. The method can be adapted on automated standard analyzers and provides a reliable clinical measurement of calprotectin in faecal samples and extracts. The method is comparable to commerical two-site sandwich ELISA. The disclosed method counters spontaneous agglutination caused by calcium ions and low-molecular weight calcium-binding S100 proteins as observed with conventional PETIAs. The method can be used for measuring the presence of human calprotectin in stool, urine, serum, plasma, synovial liquid and other body liquids. Metrological traceability and high commutability with conventional immunoassays (ELISA) has been shown despite of different measurement principles used.

Abstract: A method of diagnosis of histamine intolerance in a person suspected of suffering from histamine intolerance syndrome. Isotope-labeled histamine metabolites, namely imidazole acetic acid and methylimidazole acetic acid are identified and measured in serum, plasma, urine and other bodily fluids following derivatization with a hydrazinoquinoline derivatization agent using the LC-MS/MS technique. The method and analytical technique is very sensitive and allows a safe use of an isotope-labeled oral histamine load as well as time-dependent measurements of the total activity of secreted and membrane-associated DAO enzymes for the sake of a differential diagnosis of histamine intolerance syndrome compared to food allergy, food hypersensitivity or food intolerance.

Abstract: In vitro method for determining the type and severity of a gastrointestinal disorder in a subject suspected of suffering irritable bowel syndrome (IBS), comprising the steps of a) performing an assay method for detecting the presence of ?-tryptase in a fecal sample obtained from said patient; b) measuring the concentration of ?-tryptase in said fecal sample; c) comparing said measured concentration of ?-tryptase to a first predetermined reference value; and d) assessing of said patient by assigning an increased likelihood of suffering irritable bowel syndrome (IBS) when said measured concentration of ?-tryptase is higher than said predetermined reference value, or by assigning a decreased likelihood of suffering irritable bowel syndrome (IBS) when said measured concentration of ?-tryptase is lower than said predetermined reference value.

Abstract: An analyte testing system for quantifying the presence of an analyte in a specimen by immunochromatography. The system comprises a camera test card, depicting a test cassette (10) with an immunochromatography and a handheld processor device (16) comprising a digital camera (16a), a source of light (16b) and a processor (16c), which software and hardware (16c) are configured to make a pose estimation of camera and object and the measures of light in the region of interest of the immunochromatography. The system allows an automatic camera calibration and certification as a scanner for use in point-of-care diagnostics.

Abstract: A composition comprising a monoclonal antibody against bone sialoprotein (BSP) for use in a therapy of cardioprotection in a subject suspected of suffering from fibrosis, whereby a pathological accumulation of collagen and/or the progression of fibrosis are prevented.

Abstract: The disclosure relates to a point-of-care test device for diagnosis and detection of bacterial infections and hidden septic processes in samples of bodily fluids of premature and newborns comprising a quantitative or semi-quantitative lateral flow immunoassay unit adapted for parallel detection of proteins of the S100 family and for several detection of increased amounts of S100A12 and calprotectin in blood, serum, plasma, and saliva.

Abstract: A prosthetic polylactide or collagen-containing scaffold material for treating osseous defects and neogenesis of bone, obtained by printing a scaffold composed of strings of polylactide and porous microstructures which allow passage and ingrowth of bone tissue. A soluble mixture of BSP and/or collagen is provided, and BSP and/or collagen is applied onto the strings and in the pores of the printed body to obtain a prosthetic material which induces tissue-directed ingrowth of bone tissue as well as repair and healing of damaged or diseased bone tissues and lesions. The prosthetic material is osseo-inductive and osseo-conductive. The BSP in the prosthetic scaffold material induces a tissue-directed growth of osseous tissue. No undirectional callous or overgrowing bone and cartilage tissue is observed.

Abstract: A method comprising the steps of: (a) collecting a stool sample with the analyte and transferring a defined amount of stool sample into a prepared vessel having a sieve filter and a predetermined amount of extraction solution; (b) suspending and extracting the stool sample in the extraction solution so that the analyte goes into solution; (c) filtering the extraction solution through the sieve filter and transferring a defined amount of extraction solution to a cellulosic fibrous web having predetermined absorbency; (d) rapid drying of the extraction solution on the cellulose fibrous web at ambient temperature by the capillary action of the fibrous web, wherein the fibrous web with the sample extraction solution represents a storage and transport form stable over days and weeks, on which analyte and digestive enzymes are physically separated from each other; (e) collecting and extracting the analyte from the fibrous web in a predetermined amount of assay buffer; (f) separating the fibrous web from the assay b

Abstract: A method for pre-analytical treatment of a serum or plasma sample from a patient suspected of suffering from oxidative stress, which includes contacting the sample with one or more microcapsules having a gelled alginate core and a semipermeable coating, where the alginate core includes dispersed receptors against an oxidised human parathyroid hormone (PTH) peptide. The semipermeable membrane can be obtained by layer-by-layer deposition of polycationic and polyanionic macromolecules onto the gelled core, following by hardening, crosslinking and co-acervation of the macroionic phases.

Abstract: A method for measuring the presence of calprotectin (S100A8/A) heterodimer in a biological sample using a particle-enhanced turbidimetric immunoassay (PETIA) based on monoclonal antibodies. The method can be adapted on automated standard analyzers and provides a reliable clinical measurement of calprotectin in faecal samples and extracts. The method is comparable to commerical two-site sandwich ELISA. The disclosed method counters spontaneous agglutination caused by calcium ions and low-molecular weight calcium-binding S100 proteins as observed with conventional PETIAs. The method can be used for measuring the presence of human calprotectin in stool, urine, serum, plasma, synovial liquid and other body liquids. Metrological traceability and high commutability with conventional immunoassays (ELISA) has been shown despite of different measurement principles used.

Abstract: A method for detecting and quantifying anti-neutrophil-cytoplasmic antibodies (ANCA) in a sample of bodily fluid from a patient suspected of suffering from an autoimmune disease, including the steps of contacting human polymorphonuclear neutrophils able to release extracellular traps (NETs) with microspheres to produce NET-coated microspheres, contacting the NET-coated microspheres with the sample of bodily fluid, and labeling and subsequent analyzing of anti-neutrophil-cytoplasmic antibodies by flow cytometric methods.

Abstract: An analyte testing system for quantifying the presence of an analyte in a speciment by lateral flow chromatography. The system comprises a test cassette (10) with a lateral flow chromatography and a mobile hand-held processor device (16) comprising a digital camera (16a), a source of light (16b) and a processor (16c), which software and hardware (16c) are configured to determine automatically the distance between camera and object and the measures of light in the region of interest of the lateral flow chromatography prior any retrieval of image data for further analysis and quantification of the visual signals.