Abstract: A device for collecting a specimen, including (a) a test vessel for containing a solution containing an immunocomplex, which is a complex as a result of an antigen-antibody reaction between a specimen and a magnetic-labeled antibody containing a magnetic micro-particle and an antibody fixed to the micro-particle, (b) an external magnetic field generating device for generating a magnetic field, preferably a gradient magnetic field and applying it to the solution in the test vessel to effect local concentration of the immunocomplex to a predetermined position, (c) a magnetic member for collecting the immunocomplex at the position of local concentration, and (d) a moving mechanism for achieving relative movement between the magnetic member and the test vessel.

Abstract: An immunoassay element comprising at least one layer containing a leuco dye coating composition comprising:______________________________________ Dry Weight Component Ratio (Range) ______________________________________ a) Triarylimidazole leuco dye 55-80 b) Antioxidant 7-40 c) Poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) Alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________

Abstract: A coupled pair of fiber optic fibers are used an immunoassay device. The fibers are first coupled and then drawn down to a single mode diameter. The coupler senses output ratio change due to chemical, biochemical, bioaffinity, immunogenic-type interactions and other molecular activity occuring within the evanescent field. The fusion joint of the coupler is coated with a first immunoassay component, and then surrounded with a second immunoassay component.

Abstract: Methods are provided for the detection of an analyte in a sample using a bioelectronic sensor comprising a thin surfactant polymeric electrically conducting layer to which members of specific binding pairs are bound. Specific binding of analyte or analyte competitor to the bound specific binding pair member results in a change in the conductivity of the polymer. The resultant change in conductivity is related to the presence of analyte in the sample.

Abstract: The invention relates to immunoassay reagents that are both sensitive and specific and which require no sample pretreatment. The invention reagents are particularly useful for assaying digoxin concentrations in patient sera. More particularly, the invention relates to methods and kits comprising (A) an immunoreactant immobilized on a support; and, (B) a buffer agent comprising (i) a buffering agent, (ii) sodium chloride, (iii) choline chloride, (iv) a polysaccharide, (v) fatty-acid-free serum albumin, and (vi) a non-specific reaction suppressor of the formula: ##STR1## wherein X is --NH--(CO)--NH--, --NH--(CS)--NH--, or --N.dbd.C.dbd.N--, R.sub.1 and R.sub.2, which may be the same or different, are C.sub.1 -C.sub.5 linear or branched alkyl groups, or R.sub.1 and R.sub.2, together with nitrogen, is ##STR2## or the metho-p-toluenesulfonate salt thereof, Y, which may be the same or different, is any of H, OH and halogen,R.sub.3 is --NR.sub.1 R.sub.2, --NH.sub.

Abstract: The present invention relates to the measurement of glycated hemoglobin by fluorescence quenching. The present invention uniquely involves performing two sequential fluorescent quenching measurements: one measurement of the fluorescent quenching due to total hemoglobin in the sample and a second measurement of the fluorescent quenching due to glycated hemoglobin present in the sample after the non-glycated hemoglobin is removed. Glycated hemoglobin and non-glycated hemoglobin can be separated by a variety of methods as described herein, including ion capture and phase separations.

Abstract: A solid phase reagent is provided which comprises a carrier having a surface onto which functional groups containing a negative charge or a lone pair of electrons and/or free radicals containing a negative charge or a lone pair of electrons have been introduced and having .beta.2-glycoprotein I coated on the surface. Using this reagent, antibodies specific to antiphospholipid syndrome can be specifically assayed. Moreover, antibodies specific to antiphospholipid syndrome can be assayed differentially from antibodies specific to infectious diseases by using the solid phase reagent described above or a further modified solid phase reagent.

Abstract: A test kit and method for the amplification and detection of specific antigen cells using a probe. The method includes reacting the probe-specific cells with enzyme-conjugated molecules to form separate molecules. The specific antigen cells are mixed with a selected antibiotic which antibiotic is adversely affected by the enzyme in the reporter molecules and incubating the mixture to promote a bacterial chain reaction forming satellite colonies of bacteria microcolonies about the specific cells which amplifies the cells. The method then includes detecting the amplified probe-specific cells by observing the satellite colonies.

Abstract: Methods of glycosylation analysis are described in which a sample containing one or more specific oligosaccharide(s) (the analyte) is contacted with a surface on which is immobilized a glycosidase specific for the analyte and/or a specific binding partner for a product of the action of a glycosidase on the analyte. The surface may be the active surface of a biosensor, e.g., a biosensor based on the principle of frustrated total reflection.

Abstract: Acridinium sulfonylamides and isomers, such as phenanthridinium sulfonylamides, may be employed in applications including chemiluminmescent immunoassays. Methods for synthesis of these compounds include contacting an amine with a sulfonylhalide to form a sulfonamide and acylating with an activated carboxylic acid of an acridine or isomer thereof. The N-sulfonyl-9-acridinium carboxamide and isomers may be conjugated to antigens, haptens, antibodies, and nucleic acids for use in chemiluminescent assays.

Abstract: The present invention provides chromatographic assay devices that can perform multiple assays simultaneously in the same test strip, as well as methods for their use. One of the assays can be an immunological assay to detect an antigen, such as human chorionic gonadotropin, while another assay can be a serological assay to detect an antibody, such as anti-rubella antibody. An assay device according to the present invention can comprise: (1) a first opposable component including at least one chromatographic medium having a specific binding partner to the first analyte and a specific binding partner to the second analyte immobilized thereto in separate, discrete, non-overlapping zones; and (2) a second opposable component including an absorber.

Abstract: A phosphorescence assay system. The phosphorescent label for immunoassays is palladium (II) octaethylporphine alphaisothiocyanate. The labeling agent has a Stokes shift of not less than 150 nanometers. Method for preparing the palladium (II) phosphorescent label is also shown.

Abstract: Anti-viral material comprising a mannose-specific lectin obtained from a bulb of the plant family Amaryllidaceae, for example Narcissus pseudonarcissus, and the use of this material to produce a medicament and a vaccine. The material is effective against RNA viruses which contain glycoproteins with mannose (alpha-1>3) or (alpha-1>6) mannose linkages, for example HIV or HTLV such a Human Immunodeficiency Virus (HIV) and Human T Lymphotropic Virus (HTLV) and can also be used as a diagnostic.

Abstract: The present invention includes novel digoxin assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion substance, and a solid phase material containing a reaction site comprising a polymeric cation substance having a nitrogen content of at least about two percent. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: Antigenic compositions are disclosed for use in diagnostic kits and the like for detecting the presence of antibodies specific for Campylobacter pylori, bacteria often associated with the occurrence of Type B gastritis and peptic ulcer disease. Samples of bodily fluids, for instance, may be contacted with immobilized antigen which is then washed and tested for the occurrence of significant levels of antigen/antibody complex. Levels exceeding a predetermined positive threshold are indicative of antibodies to Campylobacter pylori in the sample tested. Kits employing the antigenic compositions of the invention preferably include means for detecting the antigen/antibody complex such as materials and reagents for conducting an enzyme-linked immunosorbent assay, Western blot technique, liposome-based assay or other known detection tests.

Abstract: An in vitro immunoassay to detect and quantitate soluble crosslinked and non-crosslinked DesAABB fibrin polymers in a sample from a subject. The assay can be used to support a diagnosis of, to evaluate, and to monitor, in a mammalian subject, a thrombotic event, including, but not limited to, myocardial infarction, pulmonary embolism, stroke and deep vein thrombosis.

Abstract: The present invention relates to an apparatus for performing a fluoroimmunoassay, the apparatus comprising an excitation light source, a fluorescence detector, an optical fiber for an excitation light from the excitation light source to which an antigen or antibody is bound, and a spectroscope, in which the mentioned antigen or antibody is bound to an outgoing end surface of the optical fiber for the excitation light. In the apparatus the spectroscope is constructed so that it introduces the excitation light emitted from the excitation light source to a incident end surface of the optical fiber for the excitation light and introduces a fluorescence emitted from a fluorescence-labeled antibody or antigen which forms an immunological complex with the antigen or antibody to the fluorescence detector. In the apparatus the outgoing end surface of the optical fiber for the excitation light has a transmittance for the excitation light from the excitation light source.

Abstract: The present invention provides a test strip for detecting, in a sample from a human subject, the presence of an antigenic substance which comprises a solid support, an antibody directed against the antigenic substance bound to a first discrete area on the solid support, an anti-human antibody bound to a second discrete area on the solid support as a positive control, and an antibody directed against an antigen which does not naturally occur in human subjects bound to a third discrete area on the solid support as a negative control. The present invention also provides a test strip for detecting, in a sample from a human subject, the presence of an antibody which comprises a solid support, an antigenic substance bound to a first discrete area on the solid support, an anti-human antibody bound to a second discrete area on the solid support as a positive control, and a negative control bound to a third discrete area on the solid support.

Abstract: An enzyme-labelled antibody adapted for use in a homogeneous immunoassay is provided. The enzyme-labelled antibody is a conjugate of an enzyme with two or more different monoclonal antibodies, each of the monoclonal antibodies being capable of specifically recognizing and binding to a different epitope of the same antigen. By using the enzyme-labelled antibody in the homogeneous enzyme immunoassay process, an analyte can be quantitatively analyzed at a higher sensitivity through a simple operation. Also provided is a dry immunoassay element comprising an immunological reaction layer containing the enzyme-labelled antibody. By the provision of such an immunoassay element, a further simplified quick analysis of an analyte is realized to give an accurate result.

Abstract: The present invention provides an accurate, rapid and precise methodology for assessing maturity of the lungs in a fetus prior to birth, especially for premature fetuses having a gestation period of 37 weeks or less. The methodology quantitatively measures a specific phosphoglyceride, dipalmitoyl phosphatidyl choline, in samples of amniotic fluid for the assessment of fetal lung maturity. The process enzymatically cleaves such phophoglycerides and preferably detects the resulting diacylglycerols by HPTLC-reflectance spectrodensitometry.