Abstract: The present invention provides a storable POD conjugate solution, characterised by a pH value of 5.0 to 6.5, adjusted by means of an organic buffer substance with a concentration of 40 to 100 mmol/l, and 0.05 to 1.0 mol/l magnesium aspartate.

Abstract: The invention concerns a virus solution which contains a detergent having the general formula I and serves to stabilize the virus solution as well as its production and use in heterogeneous immunoassays for the detection of antibodies against viruses.

Abstract: The present invention is directed to a new assay procedure and improved solid phase assay devices for use with a so-called physical developer. The invention provides a new assay procedure for detecting the presence of an analyte in a fluid sample using a tracer having a metal label which signal is enhanced by applying a physical developer. The assay is performed with a device having a support for a test area and having attached thereto a binder specific for the analyte to be detected. The assay comprises the steps of directing the fluid sample and the tracer through a porous medium into contact with the test area at a controlled flow rate to allow binding of the analyte with the binder and the tracer to the analyte, directing a physical developer through said porous medium to amplify the signal generated by the tracer, and separating the device to allow the test area to be read. The invention further relates to devices and immunoassay test kits for carrying out the improved immunoassay procedure.

Abstract: The invention relates to an agent and process for treating body fluids in the immunological determination of neopterin using a specific antibody against neopterin and a detection system. The agent is characterized in that it contains an oxidizing agent.

Abstract: The present invention provides a bisulfite-based tissue fixative that improves morphology, antigen retention, and antigenicity. The fixative is suitable for use with sections of frozen tissue, cytology preparations (including touch preparations and blood smears) and other specimens used for immunohistochemical analysis. The fixative comprises an acidic buffer and a bisulfite salt in an effective amount for tissue fixation. In a preferred embodiment, the tissue fixative comprises a bisulfite salt in a concentration of from about 0.01 to about 0.25M, preferably, 0.02 to 0.25M, in an acidic buffer having a pH of from about 2 to about 6.

Abstract: A method for detecting an analyte is disclosed in which the analyte is brought into contact with at least one receptor which is bound to or can be bound to a solid phase. In order to avoid unspecific interferences the addition of a glycosidic surfactant is proposed.

Abstract: The present invention provides an improved buffer solution for conducting an immunological method for measuring apoprotein of human tissue factor, and a kit therefor.

Abstract: A method for measuring the number of living microorganisms in a specimen which comprises entrapping the microorganisms on a hydrophobic filter after the dyeing thereof, or alternatively dyeing the microorganisms after entrapping them on the hydrophobic filter, removing excessive coloring matter by washing, and then determining the number of the microorganisms by the degree of coloration thereof. A kit for measuring the number of living microorganisms which comprises a hydrophobic filter, a syringe to which the filter is fittable, a coloring matter solution, a cleaning solution, and a color reference table. The present invention enables the rapid and convenient measurement of the number of living microorganisms in the specimen without use of special equipment. In accordance with the present invention, the measurement is usually completed within ten minutes.

Abstract: Agents for immunochemical tests which contain polymers containing carboxyl groups and processes for carrying out such tests are described. These polymers are capable of improving the results obtained with such tests, in that they suppress non-specific reactions and increase the sensitivity of the tests.

Abstract: This invention relates to a novel reagent and a method of using the reagent in an immunoassay to detect antigens, particularly antigens immunocomplexed with their corresponding or cross-reacting antibodies. In particular, this reagent and method increase the detection of human immunodeficiency virus HIV-1 p24 core antigen.

Abstract: An aqueous wash composition has been found useful in methods for determination of specific binding ligands. The composition is buffered to a pH of less than or equal to 6 or greater than or equal to 9. It also includes as its essential component at least about 0.1 weight percent of an anionic surfactant which is represented by the formula:[A-SO.sub.3+y ].sup.-(1+y) [X.sup.+m ].sub.nwherein A is a hydrocarbon having a molecular weight of at least about 180, X.sup.+m is hydrogen or a monovalent or divalent cation, m is 1 or 2, is 0 or 1, and n is 1 or 2 provided that m and n are not both 2. Optionally and preferably, the wash composition also includes a nonimmunoreactive protein. This wash composition is particularly useful in methods for determination of microorganisms associated with periodontal diseases. Such methods can be of a variety of formats, but immunometric assays are particularly useful. The wash composition can be included as part of a diagnostic test kit.

Abstract: Amine oxide-containing agents for immunochemical assays are described.The amine oxides are contained in constituents of agents for such assays which are used for receiving samples. The amine oxides are also contained in those constituents of the agent in which the immunochemical reaction takes place. The amine oxides bring about an improvement of the assay result, i.e., they increase the sensitivity of the detection and of the determination of an analyte contained in biological material.

Abstract: The invention concerns a method of detecting proteins, especially HIV and CMV antibodies in body fluids using solid-phase immune reaction with a buffer containing an animal serum and/or a non-ionic surfactant in a phosphate or carbonate buffer together with further additives selected from inorganic salts, water-soluble polymers, organic compounds, and propionic acid and their derivatives and mixtures. The buffer makes it possible to reliably eliminate false positive results.

Abstract: The present invention is concerned with a combination for the preservation of diagnostic tests, characterized by a content of at least two components selected from the group comprising 2-methyl-4-isothiazolin-3-one hydrochloride, 2-hydroxypyridine-N-oxide, chloroacetamide, (N,N-methylene-bis-(N-(1-hydroxymethyl-2,5-dioxo-4-imidazolidinyl))-urea and 5-bromo-5-nitro-1,3-dioxan.The present invention is also concerned with a preserved diagnostic test kit, comprising test reagents and at least two preservation agents selected from the group comprising 2-methyl-4-isothiazolin-3-one hydrochloride, 2-hydroxypyridine-N-oxide, chloroacetamide, (N,N-methylene-bis-(N-(1-hydroxymethyl)-2,5-dioxo-4-imidazolidinyl))-urea and 5-bromo-5-nitro-1,3-dioxan.

Abstract: A method for assaying an immunologically active substance based on the antigen-antibody reaction in a liquid phase, and a reagent for use in the method are disclosed. This method comprises adding a reagent containing a compound represented by the general formulaR.sup.1 O---[(CH.sub.2 CH.sub.2 O).sub.m (AO).sub.n ]--R.sup.2(wherein R.sup.1 and R.sup.2 each represents a hydrogen atom or a hydrocarbyl group containing 1 to 5 carbon atoms, AO represents an oxyalkylene group containing 3 to 4 carbon atoms, m and n represent the number of oxyethylene groups and that of oxyalkylene groups, respectively, with said oxyethylene groups and oxyalkylene groups forming a random copolycondensate and having a molecular weight of 1000 to 20000, and the ratio of m/n being 60/40 to 90/10).

Abstract: The invention concerns a method for detecting an analyte in a blood sample or a derived fraction thereof. In this method one uses the binding affinity between the analyte and its specific binding agent. Moreover, a reaction component containing a peroxidase label is added to the sample and specific binding agent to form a reaction mixture. The incubation of the reaction mixture, containing the analyte and its specific binding agent, with the peroxidase-labeled reaction component has to be carried out in the presence of a quaternary ammonium salt or ionic surfactant.

Abstract: The present invention relates to the stabilization of enzyme-labeled anti-human interferon-.beta. antibody for use in an enzyme immunoassay of human interferon-.beta. and provides a freeze-dried composition containing an anti-human interferon-.beta. antibody which has been freeze-dried in the presence of trehalose as a nonreducing disaccharide. The freeze-dried composition according to the present invention whose reduction in enzymatic activity remains minimized even when stored for a long period of time is conveniently incorporated into an EIA kit. No conventional non-volatile buffer solution such as a phosphate buffer solution is added to the original freeze-dried liquid of the present invention.

Abstract: An aqueous alcohol buffer solution for substantially ambient, in vitro preservation of mammalian cells for a selected duration. The solution generally contains a water-miscible alcohol in an amount sufficient to fix the sample cells without coagulation, an anti-clumping agent, and a buffer agent to maintain the solution at a pH within a range of four to seven.

Abstract: A stabilized prolactin calibrator is disclosed. The calibrator has a pH from about 5.5 to about 9.0, and contains prolactin in a 0.01 M to 0.2 M matrix of tris-(hydroxymethyl)aminomethane which additionally contains about 0.3 to 4 percent of bovine serum albumin, about 0.05 to 0.2 percent of sodium azide and from about 0.01 to about 0.2 mole/liter NaCl.

Abstract: The invention concerns a method for the determination of a partner in an immunological reaction based on an immunoassay in which one of the reaction partners is present in a solid phase, wherein a polyethylene oxidepolypropylene oxide block copolymer having the formula I ##STR1## is used as the surface-active agent in which a can have a value between 40 and 150 and b a value between 10 and 50, which is characterized in that a hydrophilic block copolymer composition having the formula I is used which in a 1 % aqueous solution (weight/volume) has a surface tension of at least 45 mN/m and in which the average molar ratio of ethylene oxide groups to propylene oxide groups (2a/b) in the composition is at least 5.8. In addition the invention comprises a reagent for carrying out the above method.

Abstract: An aqueous wash composition has been found useful in methods for determination of specific binding ligands. The composition is buffered to a pH of less than or equal to 6 or greater than or equal to 9. It also includes as its essential component at least about 0.1 weight percent of an anionic surfactant which is represented by the formula:[A-SO.sub.3+y ].sup.-(1+y) [X.sup.+m ].sub.nwherein A is a hydrocarbon having a molecular weight of at least about 180, X.sup.+m is hydrogen or a monovalent or divalent cation, m is 1 or 2, y is 0 or 1, and n is 1 or 2 provided that m and n are not both 2. Optionally and preferably, the wash composition also includes a nonimmunoreactive protein. This wash composition is particularly useful in methods for determination of microorganisms associated with periodontal diseases. Such methods can be of a variety of formats, but immunometric assays are particularly useful. The wash composition can be included as part of a diagnostic test kit.

Abstract: A method for the determination of a partner in an immunochemical reaction, in which one of the partners, which is dissolved in an aqueous fluid, is allowed to react with the other partner, which is covalently bonded to a solid phase, which comprises allowing the reaction to take place in the presence of 0.1 to 3 g/100 g of the aqueous fluid of a surfactant of the formula ICH.sub.3 --(CH.sub.2).sub.m --R--(CH.sub.2 --CH.sub.2 --O).sub.n --HIin which R is O, NH or CH.dbd.CH--(CH.sub.2).sub.p --O with m being 3-26, n being 7-40 and p being 5-15, and an agent suitable for this purpose, are described.

Abstract: Heme-containing proteins, such as cytochrome c, are useful in admixture with enzyme-labeled immunoreactants, such as peroxidase-labeled antibodies or fragments thereof. The heme-containing proteins and enzyme-labeled immunoreactants can be supplied in a buffered composition as part of a test kit. The buffered composition comprising the heme-containing protein and peroxidase-labeled immunoreactant excludes 4'-hydroxyacetanilide, which is a phenolic electron transfer agent. The composition can be used in immunoassays for detecting various immunologically reactive species, such as hCG, and chlamydial or gonococcal antigens.

Abstract: A flow injection nonaqueous solvent neutralization titration process and system is provided. The predetermined quantity of a known titrant is used to derived calibration values based on different predetermined concentrations of a desired component in a sample. The quantity of the titrant agent in excess of an amount necessary to completely react with the sample is added and then subsequently the amount of the unreactant titrant agent is determined. From this value, the calibration values that have been stored, for example, in a look-up table can be used to determine the actual concentrations of the desired component in the sample.

Abstract: Inclusion of alginate in enzyme-conjugate incubation solutions is used to improve performance of immunoassays. The total binding of antibody-signal producing species conjugate is enhanced and the specific binding is enhanced more than the non-specific binding. This allows a lower detection limit to be achieved in these assays.

Abstract: A formulation for use in detecting and/or determining peroxidase activity comprises a mixture in solution of tetramethylbenzidine, hydrogen peroxide, a buffering agent and bacitracin as a stabilizing agent. The formulation is used as a peroxidase substrate that is stable in solution for an extended period of time and provides enhanced color sensitivity.

Abstract: A method of stabilizing the glucose content of a blood sample applied to a sorbent for drying is provided. A solution of sodium fluoride or other glycolysis inhibitor is applied to a sorbent. A blood sample for glucose determination is then applied to the sorbent whereupon glycolysis is immediately inhibited. The blood sample may then be dried for shipping without loss of glucose content during the drying period.

Abstract: A test device having the following meritorious effects is obtained in accordance with the present invention by using at least one composition selected from the group consisting of ink compositions for detecting glucose, for detecting protein, for detecting urobilinogen, and for detecting occult blood in a body fluid, and for detecting the pH thereof:a) The test device is stable during storage in atmospheric air for a long period of time, presenting no discoloration phenomenon;b) The test device has high sensitivity coupled with excellent measurement performance;c) The regions for detecting glucose and the other body fluid ingredients and the pH can be formed directly on the surface of the test device by printing, allowing the test device to be formed by mass production and the process steps to be reduced; andd) The ink compositions for detecting glucose, etc. are stable, and can be handled easily.

Abstract: A process for the removal of non-specific turbidities in the carrying out of determinations according to the immuno-assay principle, wherein an inorganic boron compound is added to the sample solution in combination with a buffer system.

Abstract: The invention relates to assays of a monokine in a biological fluid, in particular in a blood sample, in particular of TNF or of IL-1. According to the present invention, the monokine in the serum or plasma obtained from whole blood stimulated with a mitogenic agent is assayed prior to any separation between the plasma (or serum) and the blood cells. According to another subject of the invention, the monokine is assayed in the case of an immunometric assay employing an oligoclonal system, consisting of several different monoclonal antibodies adsorbed on a solid phase and a non-adsorbed labeled antibody.The invention also relates to immunoassay kits.

Abstract: The present invention relates to improved specific binding assay methods, kits and devices utilizing chromatographically mobile specific binding reagents labelled with colloidal particles. Specific binding reagents labelled with colloidal particles such as gold and selenium may be subjected to rapid chromatographic solvent transport on chromatographic media by means of selected solvents and chromatographic transport facilitating agents. Further, impregnation of solid substrate materials with labile protein materials including colloidal particle and enzyme labelled reagents in the presence of meta-soluble proteins provides for the rapid resolubilization of such materials which have been dried onto such substrate materials.

Abstract: An assay which is responsive to the levels of anti-p24 antibodies in serum samples is provided which comprises the steps of: (a) forming a test mixture comprising the sample and an antigen solution containing free p24 antigen within a predetermined concentration range: (b) incubating the test mixture under conditions whereby anti-p24 antibodies from the sample, if any, can react with the free p24 antigen to form antibody-antigen complexes; (c) determining the concentration of free p24 antigen remaining in the test mixture after the incubation; (d) determining the concentration of free p24 antigen in the antigen solution; and (e) calculating the difference between the concentration of free p24 antigen in the antigen solution and the concentration of freee p24 antigen in the test mixture after the incubation.The difference calculated in step (e) represents the "binding capacity" of the serum sample for p24 antigen.

Abstract: There is disclosed, in an immunoassay employing an immunoassay reagent comprising liposomes comprised of at least any one of phospholipids and glycolipids, a marker material enclosed in said liposomes, and an antibody or part of the antibody, or an antigen, immobilized on said liposomes by a cross-linking method, the improvement wherein a material for preventing nonspecific lysis of the liposomes is made present together in a reaction mixture.

Abstract: A method for enhancing chemiluminescence which uses a heterocyclic compound of the formula: ##STR1## wherein R.sub.1 is an oxygen or sulfur atom or an imino group optionally substituted by 4-hydroxyphenyl, and R.sub.2, R.sub.3 and R.sub.4 are a hydrogen or halogen atom, an optionally substituted hydrocarbon residue, a heterocyclic group or the like in a luminescence system.

Abstract: A lyophilized mixture of reactants for an immunoassay includes antibody-gold sol particle conjugates, antibody latex particle conjugates, polyethylene glycol, a polyethylene glycol p-isooctylphenyl ether detergent and a sugar such as dextrin or trehalose. The polyethylene glycol is present to enhance binding of the immunoreactants and the polyethylene glycol p-isooctylphenyl ether detergent is present to prevent non-specific interactions. The sugar prevents agglomeration of the polyethylene glycol and polyethylene glycol p-isooctylphenyl ether in the lyophilized mixture at room temperature and facilitates retention of a homogenous distribution of the ingredients of the mixture to thereby enhance shelf life and redistribution of the mixture in an aqueous test system.

Abstract: A method for producing a binding assay device composed of antigens on a cellulose nitrate, cellulose nitrate/acetate or similar solid phase is described. The method involves applying to a solid phase a small amount of an allergen composition, or a pretreated allergen composition, containing a certain concentration of allergen and drying the solution. The device is used by contacting a patient test sample to the immobilized allergen and determining whether or not the test sample contains IgE antibodies for the allergen.

Abstract: An attenuator is included in a reagent medium of a luminescent specific-binding assay to suppress undesirable extraneous light. In one such assay, an analyte in a sample is reacted with a specific binding partner attached to a solid surface, forming an immobilized pair at the surface. One member of the immobilized pair is then allowed to react with a specific binding partner previously conjugated with one component of a luminescent reaction system, and the remaining components are provided in the reagent medium. The resulting light emitted in the luminescent reaction is recorded on photographic film or other photodetector as a measure of the presence and quantity of the analyte in the sample.

Abstract: A composition including a sulfhydryl-containing reducing agent is stabilized for long term storage with a hydrophilic polymer. This composition can be combined with one or more reagents useful for extracting antigens from chlamydial or gonococcal organisms. The extracted antigen can be determined using immunological reactions and appropriate labeled reactants.

Abstract: Methods are disclosed for inactivating interfering binding proteins in a immunoassay for a member of a specific binding pair (sbp). The method comprises including in an assay medium containing a sample suspected of containing an sbp member and an interfering binding protein an effective amount of a water soluble compound having two substituted or unsubstituted phenyl groups linked to a common atom. When the sbp member or its sbp partner has two phenyl groups linked to a common atom, the compound has a number of groups other than hydrogen attached to the phenyl groups and the atom that differs by at least two from the number of such groups on the sbp member. When the sbp member or its sbp partner has two phenyl groups linked to a common atom and the binding protein is not an antibody, the compound has only one group other than hydrogen attached to a phenyl group or the common atom.

Abstract: A method is provided for combining normally interacting reagents in a liquid single reagent and preventing complex formation using a surfactant and then reversing the inhibition by adding a cyclodextrin. The method finds particular use in diagnostic immunoassays. Reagents facilitating the invention are also provided.

Abstract: A method for drying mammalian cells, such as erythrocytes, lymphocytes, leukocytes and platelets onto a solid-phase support for use in solid-phase immunoassays through use of a drying solution and an article for use in immunoassays prepared by such method. The method comprises immobilizing a monolayer of cells onto the solid-phase support by non-covalent binding. This is accomplished by staining the solid-phase support with an organic dye having a net positive charge which permits non-covalent binding of the cells which carry a net negative charge to the solid-phase support. These cells are dried or fixed to the solid-phase support by addition of a drying solution which comprises an aqueous solution of a monosaccharide, disaccharide, trisaccharide or cyclitol and a salt. The preferred monosaccharide is D-(31 )glucose and the preferred salt is sodium chloride. The preferred drying solution comprises a 1.0M solution of dextrose and a 154 mM solution of sodium chloride.

Abstract: A method for separation-free solid phase immunoassay of an analyte includes contacting an antianalyte attached to the surface of a solid support with the analyte, a light absorbing material and a tracer for the analyte which includes a label. The resulting mixture is incubated and chemiluminescence is generated. All of the chemiluminescence is absorbed by the light absorbing material except that associated with the bound tracer whereby the only emission detected is due to the bound tracer. Since emission from free tracer in the fluid phase of the assay medium is not detected, separation of the bound and free fractions is unnecessary. The invention includes a kit of materials useful in performing an immunoassay in accordance with the method of the invention.

Abstract: An aqueous wash solution is buffered to a pH of from about 5 to about 9 and contains at least about 0.01 weight percent of a compound comprising a dodecyl sulfate anion and an alkali metal or ammonium cation, such as sodium dodecyl sulfate. This wash solution is particularly useful in a method for the determination of an immunological ligand. Particularly, it is useful for washing the immunological complex formed between the ligand and a receptor molecule therefor. Unreacted materials can be readily separated from the complex by the washing, particularly if the separation is carried out using a filtration membrane in a test device. a test kit for ligand determination comprises the wash solution as well as one or more receptors for the ligand, at least one of which is labeled for detection. This kit is particularly useful for measuring human chorionic gonadotropin (hCG) as an early indicator of pregnancy.

Abstract: Incubation media intended for solid-phase immunometric assays and containing lactoferrin are described. Compared with the media used hitherto, these incubation media have the advantage that they prevent, especially in the case where heated sample material is used in the assays, false results on determination of antigens or antibodies.

Abstract: Contact lenses can be sterilized effectively in a short time, by using a kit for contact lens sterilization which comprises an oxidizing agent for sterilizing contact lenses and a reducing agent for making nontoxic the oxidizing agent still remaining after sterilization and wherein the oxidizing agent and the reducing agent each have such a property and form that they do not substantially react with each other in the kit and that when they are placed in water substantially simultaneously, the major portion of the oxidizing agent dissolves in water more rapidly than the major portion of the reducing agent. Further, with this kit, the sterilized contact lenses can be made nontoxic without fail.

Abstract: The invention relates to liposome compositions comprising liposomes in an aqueous buffer at a pH of 6.5-8.5 and including a polyol in an amount of from 0.6 to 1.5 g per 100 ml of buffer. Also, the invention further relates to liposome compositions comprising a liposome including a detectable marker wherein said liposome may be derivatized with a ligand and the use thereof in an assay for analyte of interest.

Abstract: Serum samples for vitamin B.sub.12 analysis can be pretreated using a combination of peroxy acid and dithiothreitol. The pretreatment makes vitamin B.sub.12 bound to serum binding proteins available for analysis by any of a variety of currently available assay techniques. The pretreatment finds particular use in an assay using solid phase intrinsic factor as a specific binding protein.

Abstract: The present invention is directed to a fluorescence polarization assay for opiate alkaloids and their metabolites, to the various components needed for preparing and carrying out such an assay and to methods of making these components. Specifically, tracers, immunogens and antibodies are disclosed, as well as methods for making them. The tracers and the immunogens are made from substituted opiate alkaloids. A fluorescein moiety is included in the tracers, while a poly(amino acid) forms a part of the immunogens. The assay is conducted by measuring the degree of polarization retention of the fluorescence resulting when a sample mixed with antiserum and tracer is irradiated with plane-polarized light.

Abstract: Immunoglobulins are purified by adsorption upon and adsorbent therefor using a buffer having a pH value of about pH 6 to pH 10 and containing at least one polycarboxylic acid in a concentration of about 0.5 M to about 0.9 M.

Abstract: An article of manufacture comprising a blood-collection tube containing an acid such as citric acid in an amount effective to adjust the pH of the blood to be collected in the tube to a level between 5.0 to 7.0. The blood-collection tube may also contain NaF in an amount to produce a concentration thereof between 0.1 to 0.5 mg/ml of the blood.