Abstract: The present application relates to an antibody, kit, detection method, and sample analyzer for detecting thyroid stimulating hormone. Specifically, the present application relates to a monoclonal antibody or antigen-binding antibody fragment thereof that specifically binds to thyroid stimulating hormone (TSH), wherein the antibody can recognize TSH variant R55G and does not cross-react with an ?-subunit shared by human luteinizing hormone (LH), follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG), and free glycoprotein hormones, and is particularly suitable for developing TSH detection kit with a functional sensitivity of ?0.0015 ?IU/ml. The present application also relates to a thyroid stimulating hormone detection kit, detection method, and sample analyzer.

Abstract: This application provides an antibody or antigen-binding fragment thereof that binds to thyroglobulin, including: a heavy chain variable region having: CDR-H1 having an amino acid sequence selected from SEQ ID NOs: 1, 7, 13, 19, 25, 31, and variants thereof, CDR-1-12 having an amino acid sequence selected from SEQ ID NOs: 2, 8, 14, 20, 26, 32, and variants thereof, and CDR-H3 having an amino acid sequence selected from SEQ ID NOs: 3, 9, 15, 21, 27, 33, and variants thereof; and a light chain variable region having: CDR-L1 having an amino acid sequence selected from SEQ ID NOs: 4, 10, 16, 22, 28, 34, and variants thereof, CDR-L2 having an amino acid sequence selected from SEQ ID NOs: 5, 11, 17, 23, 29, 35, and variants thereof, and CDR-L3 having an amino acid sequence selected from SEQ ID NOs: 6, 12, 18, 24, 30, 36, and variants thereof.

Abstract: The present application relates to a PINP-specific antibody, kit and use thereof. Specifically, the present invention provides a PINP-specific antibody, as well as a kit containing the antibody, and use thereof in detecting the presence or level of tPINP in a sample.

Abstract: The present invention describes the method for determining the risk of future major adverse cardiovascular events, which comprises detection proteolytic fragments of IGFBP-4 or IGFBP-5 (insulin-like growth factor binding protein 4 or insulin-like growth factor binding protein 5) in patients' blood. The present invention provides antibodies and immunoas-says, suitable for specific measurement of proteolytic fragments of IGFBPs. In current invention the IGFBP fragments are suggested to be utilized as blood biomarkers for the risk prediction of major adverse cardiovascular events (MACE).

Abstract: Disclosed is a method for detecting IGFBP-4 (Insulin-like Growth Factor Binding Protein-4) fragments. The method uses antibodies or antigen binding fragments that specifically recognize epitopes on IGFBP-4 fragments. The IGFBP-4 fragments include the N-terminal and C-terminal fragments resulting from PAPP-A dependent cleavage of IGFBP-4. Assay and diagnostic methods using detection of IGFBP-4 fragments are also disclosed.

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: The present invention relates to a method for diagnosing a cardiovascular or cancer disease by detecting IGFBP-4 (Insulin-like Growth Factor Binding Protein-4) fragments in a patient sample. Antibodies specifically recognizing novel epitopes originated by enzyme-dependent cleavage of IGFBP-4 are also disclosed.

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: The present invention relates to a method for diagnosing a cardiovascular or cancer disease by detecting IGFBP-4 (Insulin-like Growth Factor Binding Protein-4) fragments in a patient sample. Antibodies specifically recognizing novel epitopes originated by enzyme-dependent cleavage of IGFBP-4 are also disclosed.

Abstract: The present invention describes the method for determining the risk of future major adverse cardiovascular events, which comprises detection proteolytic fragments of IGFBP-4 or IGFBP-5 (insulin-like growth factor binding protein 4 or insulin-like growth factor binding protein 5) in patients' blood. The present invention provides antibodies and immunoas-says, suitable for specific measurement of proteolytic fragments of IGFBPs. In current invention the IGFBP fragments are suggested to be utilized as blood biomarkers for the risk prediction of major adverse cardiovascular events (MACE).

Abstract: The present invention relates to an immunoassay for detection of BNP, proBNP and fragments thereof. Essentially the assay comprises: a) contacting the antigen with a first antibody specific to a fragment corresponding to amino acids 11-22 of BNP, or to a part of this peptide comprising at least three amino acids of said sequence, to obtain a first order immune complex. b) contacting the first order immune complex obtained at step (a) with a second antibody recognizing said first order immune complex, to obtain a second order immune complex, wherein said antibody is unable to recognize free BNP, proBNP or free first antibody; c) Detecting the second order immune complex.

Abstract: The present invention relates to a method for diagnosing a cardiovascular or cancer disease by detecting IGFBP-4 (Insulin-like Growth Factor Binding Protein-4) fragments in a patient sample. Antibodies specifically recognizing novel epitopes originated by enzyme-dependent cleavage of IGFBP-4 are also disclosed.

Abstract: The present invention provides antibodies against glycosylated proBNP and NT-proBNP. The antibodies are suitable for precise immunodetection of both of the proteins in human blood. The glycosylated forms of proBNP and NT-proBNP may be utilized as an antigen for antibody generation as well as a calibrator or immunological standard in different types of immunoassays. The invention thus also relates to a stable standard or calibrator pro-Brain Natriuretic Peptide (proBNP) preparation for use in a method for detecting BNP immunoreactivity in a sample, the preparation comprising glycosylated proBNP or a fragment thereof. In addition, the present invention is directed to an assay for precisely detecting the NT-proBNP circulating in a patient's blood, wherein the level of glycosylation of the proBNP molecule is exploited. Therapeutic applications are also contemplated.

Abstract: The invention provides a method for assaying for troponin I in a sample such as serum, the method comprising a determination of the troponin I concentration in a sample using a standard preparation that comprises a complete native troponin complex. One exemplary assay for troponin I concentration according to the invention is an immunoassay. Further contemplated in the method is a step comprising contacting the sample with a Ca2+-binding agent. Another aspect of the invention is the standard preparation comprising a complete native troponin complex. Yet another aspect of the invention is a kit for use in the assay method comprising the standard preparation, a detectable label, and a troponin I binding partner, such as an anti-troponin I antibody. All aspects of the invention are usefully practiced using human materials, such as a human troponin complex, and/or human sources for samples.