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.

Abstract: A bioaffinity assay for quantitative determination in a sample of free PAPP-A, defined as the pregnancy associated plasma protein A (PAPP-A) that is not complexed to the proform of major basic protein (proMBP), where free PAPP-A is determined either i) as a calculated difference between measured total PAPP-A and measured PAPP-A complexed to proMBP, or ii) by a direct bioaffinity assay measuring only free PAPP-A. Also disclosed is a method for diagnosing an acute coronary syndrome in a person by using as marker either free PAPP-A as such or a ratio free PAPP-A/total PAPP-A, free PAPP-A/PAPP-A complexed to proMBP, or PAPP-A complexed to proMBP/total PAPP-A.

Abstract: This invention concerns a method for the assessment of bone fragility and fracture risk, or osteoporosis, in a person. In said method, the concentration of gamma-carboxylated osteocalcin (COC) and optionally also the concentration of intact or total osteocalcin (IOC or TOC, respectively) in a body fluid sample of said person is measured. The concentration of gamma-carboxylated osteocalcin (COC) so obtained is compared to the mean concentration of gamma-carboxylated osteocalcin (mean COC) in similar body fluid samples of the population of the same age and sex. Alternatively, the determined ratio COC/IOC or COC/TOC for said person, is compared to the mean ratio COC/IOC or COC/TOC, (mean ratio COC/IOC or mean ratio COC/TOC) determined from measurements in similar body fluid samples of the population of the same age and sex. A measured COC that is lower than the mean COC is used as indication of osteoporosis, bone fragility or increased risk of bone fracture in said person.

Abstract: The invention relates to an isolated osteocalcin fragment derived from human urine, said fragment being characterized in that at least one of the glutamic acids in the position 17, 21 and 24 of the amino acid sequence 1                     6   7 Tyr-Leu-Tyr-Gln-Trp-Leu-Gly-Ala-Pro-Val-Pro-Tyr-                 17              21          24 Pro-Asp-Pro-Leu-Glu-Pro-Arg-Arg-Glu-Val-Cys-Glu-                   30 Leu-Asn-Pro-Asp-Cys-Asp-Glu-Leu-Ala-Asp-His-Ile- Gly-Phe-Gln-Glu-Ala-Tyr-Arg-Arg-Phe-Tyr-Gly-Pro- Val

Abstract: This invention relates to a method for detection and/or quantification of cardiac troponin I (cTnI) in a sample derived from an individual's blood, said method being based on a sandwich immunoassay employing at least two capture antibodies and at least one tracer antibody, wherein

Abstract: This invention concerns an antibody wherein said antibody does bind with high affinity to human single-chain intact, i.e. not internally cleaved, mature and/or zymogen forms of prostate specific antigen (SCINT PSA). The antibody, obtainable through immunization with an uncleaved form of PSA and selected by its differential reactivity with the intact and internally cleaved forms, does not bind to a nicked PSA (PSA-N), wherein said PSA-N has been formed by internal peptide bond cleavage(s) of SCINT PSA resulting in two-chain or multi-chain PSA.

Abstract: The present invention relates to a nanoparticle comprising a specific binding reactant, said nanoparticle being useful for determining an analyte to which analyte or complex comprising said analyte said binding reactant is specific. Characteristic for the nanoparticle is that the diameter of said nanoparticle is less than 200 nm, said nanoparticle is coated with multiple said specific binding reactants to the extent that the affinity constant of said nanoparticle towards said analyte essentially exceeds that of free said binding reactant towards said analyte and/or the association rate constant between said nanoparticle and said analyte essentially exceeds the association rate constant between free said binding reactant and said analyte; and said nanoparticle comprises a detectable feature. The invention also relates to biochemical assays using said nanoparticle.

Abstract: The object of the invention is an improved diagnostic immunoassay method for assaying troponin I in a serum sample, wherein the improvement comprises determining the human troponin I concentration in the sample using a standard, which comprises a complete native troponin complex. The sample can also be brought in contact with a Ca2+-binding agent.