Abstract: The invention is a method of identifying the presence of, and monitoring, a disease state in a mammal which is associated with degradation of connective tissue in the mammal. The method detects and determines whether diagnostically or prognostically significant levels of YKL-40 protein and/or YKL-40 peptide are present in a biological sample. The method can be used, for example, to identify the presence of inflammatory or degenerative joint disease or degeneration of connective tissue in organs. Serum YKL-40 levels as detected and quantified by the inventive method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers. The figure shows the elution position of substantially pure serum YKL-40 on a gel filtration column.

Abstract: Method and apparatus for enabling resuspension wash and magnetic localization of sample components bound to particles with magnetic properties in reaction vessels during separation and wash for enhanced chemiluminescent signal generation in biomedical assays. The assays involve moving reaction vessels past magnetic arrays that partially localized the particles prior to passing a gap where washing occurs, with or without resuspension, after separating out the unbound components and liquid. The band of particles is further localized by a focusing magnet at the end of the array prior to dosing the vessel with acid for chemiluminescent purposes. A block of soft magnetic material is employed in place of a magnet in the gap to minimize magnetic strength at the gap. Trimmed magnets adjacent the gap cause left, then right, particle shifting that localizes the magnetizable particles. The gap enables improved resuspension by wash, whereas the localized particles enable more efficient resuspension by reagent.

Abstract: A first monoclonal antibody which specifically reacts with a human .alpha..sub.2 -plasmin inhibitor complex (PIC) and a human plasminogen; a second monoclonal antibody which reacts with PIC and also with a human .alpha..sub.2 -plasmin inhibitor; a third monoclonal antibody which reacts with PIC, but does not react with a human plasminogen and a human .alpha..sub.2 -plasmin inhibitor; hybridomas which secrete the first to third monoclonal antibodies, and an immunoassay using the first to third monoclonal antibodies.

Abstract: The invention provides phospholipid coated particles capable of specifically binding antiphospholipid antibodies and a method for preparing such particles. Methods are also provided for determining antiphospholipid antibodies in a serum or plasma. Also provided are methods for isolating antiphospholipid antibodies from a fluid and for raising specific antiphospholipid antibodies.

Abstract: A species such as a microorganism, e.g. Legionella, Giardia or Cryptosporidium, is captured by first attracting plastic coated magneticbeads or other magnetically attractable particles to a solid support such as stainless steel mesh, which particles have a selective affinity for the species, e.g. by virtue of an antibody coating, and contacting a sample containing the species with the particles on the solid support. The beads bearing the captured species may be released by reduction of the magnetic attraction of the support for the beads, e.g. by turning off an electromagnet used to magnetize the support.

Abstract: Disclosed are a kit, composition and method for cell separation. The kit includes a centrifugable container and an organosilanized silica particle-based cell separation suspension suitable for density gradient separation, containing a polylactam and sterilized by treatment with ionizing radiation. The composition includes a silanized silica particle-based suspension for cell separation which contains at least 0.05% of a polylactam, and preferably treated by ionizing radiation. Also disclosed is a method of isolating rare blood cells from a blood cell mixture.

Abstract: Two or more analytes having the same action, or having different actions in spite of their similar structures, or two or more analytes having the same action and the same detectable chemical characteristics, in samples derived from living bodies, etc., can be measured rapidly and easily by forming one or more complexes with one or more affinity substances, separating the complexes by using high pressure liquid chromatography, followed by measurement of the amount of an affinity substance or one of the analytes.

Abstract: A method and apparatus for separating solid supports formed of magnetic particles on which immunocomplexes are bound, from a liquid phase includes a reaction container containing a fluid in which magnetic particles having immunocomplex bound thereon are suspended. The reaction container is positioned at a flock forming station, where the fluid is subjected to an alternate current magnetic field having a temporally varying intensity by an electromagnetic. The magnetic particles are flocculated with each other due to the application of such varying magnetic field to form a multiplicity of flocks. A stronger magnetic field then is applied to the resulting contents in the reaction container by a permanent magnet. The flocks are magnetically fixed on the inner wall surface of the reaction container by the action of the stronger magnetic field.

Abstract: Methods are disclosed for separating a component of interest from a mixture containing the component of interest and other components. The method comprises contacting a first liquid medium containing the component of interest and other components with a second liquid medium that is of different density than and/or of different viscosity than the first liquid medium. The contact is carried out in such a way that mixing of the media is minimized or avoided. The component of interest is bound to magnetic particles. The contacted first liquid medium and second liquid medium are subjected to a magnetic field gradient to allow the magnetic particles to migrate into the second liquid medium and separation of the component of interest from other components is realized. Also disclosed are assays employing the present method. Kits for carrying out the present method and assays are also disclosed.

Abstract: Compositions and methods are provided which are useful in determining the levels of the C-telopeptide of human Type I collagen. The levels of the C-telopeptide are used as a marker of collagen degradation in an individual, and thus serve as a sensitive and specific indicator of bone resorption. Assays for the C-telopeptide find a variety of uses, including use in diagnosing metabolic bone disorders such as osteoporosis or postmenopausal rapid bone losers, monitoring the efficacy of therapeutic regimens designed to treat such disorders, determining the extent of imbalances between bone formation and resorption.

Abstract: A diagnostic test, and a device for conducting the test, for assessing whether patient chest pain is cardiac in origin and for differentiating between unstable angina and myocardial infarction as a cause of patient chest pain is described. The diagnostic test comprises simultaneously detecting at least three selected cardiac markers with the use of at least three different monoclonal or polyclonal antibody pairs, each member of which is complementary to a different marker, which is released by heart muscle at varying stages after the onset of chest pain and is indicative of the cause of the chest pain.

Abstract: A diagnostic test, and a device for conducting the test, for assessing whether patient chest pain is cardiac in origin and for differentiating between unstable angina and myocardial infarction as a cause of patient chest pain is described. The diagnostic test comprises simultaneously detecting at least three selected cardiac markers with the use of at least three different monoclonal or polyclonal antibody pairs, each member of which is complementary to a different marker, which is released by heart muscle at varying stages after the onset of chest pain and is indicative of the cause of the chest pain.

Abstract: A method and apparatus for determining qualitatively or quantitatively the presence of analyte bound to a separation media without doing a bound/free separation. In the method, the bound fraction is collected in an assay region of a body of liquid which includes the free analyte, and the assay is performed by comparing the radiant-energy response in the assay region to the radiant-energy response in a control region of the body of liquid which is free of bound analyte. The apparatus has a chamber which contains the body of liquid, one or more collection elements and a control element and position in the body of liquid parallel to an opaque wall which has a colliminating slit in registry with each element. Each slit enables sensing of the radiant-energy response from the body of liquid between the slit and its associated elements.

Abstract: A method of assaying bone collagen breakdown levels in a human subject useful to screen for the presence of bone resorption disorders. Also disclosed is a method for monitoring the progression and/or treatment response of a cancer condition which involves or has the potential to progress to a metastatic condition which involves abnormalities in bone resorption rates.

Abstract: Corticotropin Releasing Factor-binding protein (CRF-BP) is produced recombinantly and is useful for modulating the biological activity of CRF. CRF-BP or fragments thereof and/or antibodies to such polypeptides are employed in diagnostic assays to determine the levels of CRF and CRF-BP and the ratio of CRF/CRF-BP in a vascular fluid sample. Following such an assay, pregnancy-related pathological disorders, such as increased risk of premature labor, can be treated, for example, by administering CRF-BP to lower the ratio of CRF/CRF-BP to within a normal range for pregnancy. Anti-CRF-BP antibodies are also useful to purify CRF-BP and to modulate the biological effect of CRF-BPs.

Abstract: The present invention relates to a binary assay method capable of providing wide dynamic range and a high degree of precision in which analyte and labelled ligand are reacted with two independently determinable forms of solid-supported binding partners having affinity for the analyte and labelled ligand, respectively. The analyte concentration is determined from signals deriving from the resulting two forms by reference to a double standard calibration curve. A kit for use in the method is also disclosed.

Abstract: The invention is a device and a method for collecting samples mixing the samples with test reagents, and acting as a container in which the mixture can be incubated and the test reaction viewed by microscope or imaging device. This device enables an entire test to be performed in one simple step without complicated handling procedures. The device consists of a cartridge with a well with micro-lances imbedded in the bottom of the well and an overlying micro-baggy containing a mixture of reagents. There are two reagents present in the micro-baggy: the first consisting of antibodies coupled to paramagnetic microspheres and the second consisting of antibodies coupled with a fluorochrome. A test subject presses down onto the micro-baggy and at the same time punctures his/her finger or thumb on the micro-lances. Once the finger has been lanced, breaking the micro-baggy, the reagents mix with the test subject's blood. The well is then covered by a clear mylar strip.

Abstract: Methods for determining the concentration of an analyte in a sample in which an analyte gradient is established and brought into contact with one or more zones that contain binding members that interact with the analyte and thereby produce a detectable signal. Devices that may be used to practice the disclosed methods are also provided.

Abstract: This invention relates to a diagnostic tests and devices for conducting such tests at the point of care or in a diagnostic laboratory for accurate, simple, and rapid assessment of chest pain. In particular, the invention relates to differential diagnosis of the origin of chest pain, e.g., whether the pain is cardiac in origin, and for differentiating between unstable angina ("UA"), myocardial infarction ("MI"), congestive heart failure ("CHF"), and other ischemic events affecting the heart, at early onset of patient chest pain. The invention further relates to diagnosis of the stage of the MI in a patient suffering from MI, and to prognosis of such a patient.

Abstract: In a method of analyzing a body fluid sample for the presence of an analyte indicative of a physiological condition, comprising the steps of contacting the body fluid sample with an immunological binding partner which binds to the analyte, detecting binding of the immunological binding partner to the analyte, and correlating any detected binding to the physiological condition, the improvement comprising contacting the body fluid sample with an immunological binding partner which binds to ##STR1## wherein ##STR2## is hydroxylysyl pyridinoline or lysyl pyridinoline, and correlating any detected binding to degradation of type II collagen in vivo.