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: 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 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: 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.