Abstract: Surfactants bound to a ligand and dissolved in a single phase aqueous solution form a precipitate when a multivalent antiligand is added to the solution. This invention can be used in an affinity precipitation test procedure (and kit) for detecting the presence or absence of a multivalent antiligand in a sample suspected of containing the multivalent antiligand, in an affinity precipitation inhibition test procedure (and kit) for detecting the presence or absence of a target ligand in a sample suspected of containing the target ligand, and in a process for separating a multivalent antiligand from a crude material containing the multivalent antiligand.

Abstract: A method and associated materials including test kits for detecting and measuring the presence and amount of aminoguanidine and its analogs in biological samples is disclosed. Biological samples may include plasma, urine or tissue, and the present method may be used to determine the activity and effect of aminoguanidine and its analogs, particularly to the extent that such materials are useful as agents to prevent advanced glycosylation of proteins. The present invention extends to a new drug assay, suitable test kits, and to the assessment of kidney function and the potential to aid in the diagnosis of underlying pathologies where kidney dysfunction is a symptom.

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 test kit for performing a diagnostic procedure. The kit comprises a plastic base which has an upper surface. The base is formed from a plastic material and a plurality of upwardly opening nests are provided in the upper surface of the base. A test component is provided in each of the nests in a manner such that the components may be displayed and made available for use. The test components are preferably displayed in essentially the plane of the upper surface of the base and an instruction booklet is provided so as to overlie the test components at the beginning of the procedure. The arrangement of the components and the size and shape of the pages of the booklet are such that as the user follows the instructions and turns pages in the booklet, components remain hidden from view until needed in conducting the procedure. The pages of the booklet are progressively shorter from front to back in the booklet so that as the pages are turned components of the kit come into view as needed.

Abstract: The subject invention concerns a novel in vitro process for identifying and quantifying native antigens on potentially pathogenic group B streptococci bacteria present in a clinical specimen. The invention process is made possible by the discovery of novel bacterial markers denoted .gamma. and .delta. epitopes which are expressed by a variety of group B streptococcal strains.

Abstract: A method and kit for detecting a predetermined nucleotide sequence in a specimen using a nucleic acid probe modified with N-2-acetylaminofluorene (AAF).

Abstract: Monoclonal antibodies (MAbs) capable of binding to native PDGF, and MAbs capable of specifically binding to the PDGF-AA, PDGF-BB and PDGF-AB isoforms are disclosed. The subject MAbs may be used in the detection or purification of native PDGF or selected PGDF isoforms. In addition, the MAbs may be labeled with an imaging agent and used for in vivo diagnostic purposes, or combined with a pharmaceutically acceptable carrier or diluent for use within wound healing compositions.

Abstract: A water-insoluble microporous article comprises a microporous substrate having first and second outer surfaces. Affixed to at least one of those surfaces is a stabilized specific binding reagent admixed with certain hydrophilic, neutral or positively-charged binder materials. Particularly useful binder materials include certain quaternary polymers, vinylpyrrolidone polymers and acrylamide polymers. In this mixture, the reagent exhibits improved keeping stability compared to similar reagents used without binder materials. The reagent comprises water-insoluble particles to which are attached receptor molecules to a target ligand. Substantially none of the reagent is entrapped within the microporous substrate. This article is useful for the detection of a target ligand in an assay involving the specific binding reaction of the ligand with corresponding receptor molecules, and can be included in a diagnostic test kit.

Abstract: A novel immuno-dye reagent capable of detecting the presence of endotoxin in samples has been developed. The immuno-dye reagent comprises a solution of new methylene blue and an anti-endotoxin monoclonal antibody specific to a selected endotoxin. The immuno-dye reagent can be used in an assay to detect endotoxin by reacting the immuno-dye reagent with an endotoxin suspect pH adjusted sample, under hydrophobic conditions. The immuno-dye reagent can also be used in any application where binding of endotoxin is crucial, such as purifying endotoxin-contaminated solutions.

Abstract: A kit of highly uniform size microbead standards for flow cytometer alignment, compensation, and/or calibration, comprising a blank microbead population and/or an auto-fluorescent microbead population, together with two or more series of calibrated microbead populations labeled with fluorescent dye(s) which (i) prior to fluorescent dye(s) labeling, match the fluorescence spectra and fluorescence intensity of the blank and/or autofluorescent microbead population, and (ii) after fluorescent dye(s) labeling, match the fluorescence spectra and fluorescence intensity of fluorescently labeled samples to be measured on the flow cytometer. Also disclosed is a corresponding method to align, compensate, and/or calibrate a flow cytometer so as to make measurements on samples comparable and independent of the specific instrument and instrument settings.

Abstract: A chemical analysis test device for detection of a selected chemical in a biological fluid is disclosed wherein the test is preformed on a rigid base containing a detection well for holding a reagent and a specimen well for holding a sample of the biological fluid to be tested. The detection well is positioned above a concentration chamber wherein the cross-sectional area of the chamber increases as the distance from the bottom of the detection well increases. A passage connects the concentration chamber to the detection well. The specimen well has a generally hemispherical interior surface and has an opening in the bottom thereof. A strip of wicking material is secured to the base interconnecting the opening in the specimen well and the concentration chamber. A specimen of the biological fluid to be tested is deposited in the specimen well and contacts the wicking material through the opening in the bottom of the well.

Abstract: Structure-independent amplification of DNA by the polymerase chain reaction can be achieved by incorporation of 7-deaza-2'-deoxyguanosine-5'-triphosphate into the amplified DNA.

Abstract: Anti-hepatitis B virus surface protein (anti-HBS) antibody is adsorbed onto the surface of a substratum. Hepatitis B virus PreS2+S (PreS2+S) protein is then adsorbed onto the same surface through the interaction of the anti-HBS antibody with the "S" portion of the PreS2+S protein. The coated surface is then incubated concomitantly with the test sample and a radiolabelled antibody specific for the "PreS2" portion of the PreS2+S protein.

Abstract: 2-methyl-4-hexene- and 3-methyl-5-heptene-1,2-diol derivatives are disclosed together with methods for preparing such derivatives. Where the derivative is a 2-methyl-4-hexene- or 3-methyl-5-heptene-1,2-diol conjugated to a label, the conjugates are useful in immunoassays. Where the 2-methyl-4-hexene or 3-methyl-5-heptene-1,2-diol is conjugated to an immunogenic carrier, the conjugates may be employed as an immunogen for use in the preparation of antibodies. The label conjugate and the antibodies can be utilized in an immunoassay for the determination or detection of cyclosporin in a sample suspected of containing cyclosporin.

Abstract: Highly concentrated hematopoietic stem cell compositions are provided which are substantially free of differentiated or dedicated hematopoietic cells. The cells are obtained by subtraction of cells having particular markers and selection of cells having particular markers. The resulting composition may be used to provide for individual or groups of hematopoietic lineages, to reconstitute stem cells of the host, and to identify an assay for a wide variety of hematopoietic growth factors.

Abstract: Nucleic acid probes capable of specifically hybridizing to rRNA of E. coli and Shigella species and not to rRNA of non-E. coli/Shigella are described along with methods utilizing such probes for the specific detection of E. coli and/or Shigella in food and other samples.

Abstract: A method and structure are provided for controlled deposition of liquid analytical reagents on one or more reagent zones disposed in a reaction channel used for performing analytical assay procedures and the like. The substrate surface on which the reaction channel is defined is provided with a unique surface geometry wherein each reagent zone is defined in the form of a sharp, substantially flat, raised portion or mesa-shaped node. The raised node provides a discontinuity in the surface of the reaction channel which is sufficient to prevent a liquid reagent deposited thereon from spreading to adjacent surfaces and, thereby, provides a discrete or localized area to serve as a reagent zone. Controlled deposition is realized since drops of deposited reagent are prevented from spreading uncontrollably over the surrounding substrate surface while, at the same time, allowing the deposited reagent to be completely contacted and removed by the action of a liquid reaction mixture washing the reagent zone.

Abstract: A disposable, pre-packaged device as particularly suitable for conducting diagnostic procedures based on immunological reactions using specimens gathered up in the absorbent tip of a swab. The device is made up of a base component upon which a sample sensitive element is mounted and a guide member that is normally mounted on the base component in covering relationship to the reactive element. The guide member includes structure which defines an elongated passageway extending therethrough. One end of the passageway is positioned in close proximity to the sensitive element when the member is mounted on the base component. The other end of the passageway opens outwardly of the guide member. In using the device, the swab tip is pushed through the passageway and toward the sensitive element using the stick of the swab. A number of ribs are positioned in the passageway adjacent the sensitive element to squeeze the tip and express fluid therefrom as the tip is pushed toward the sensitive element.

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 method of assaying a ligand in a sample which method includes the steps of contacting the sample with components comprising(a) a specific binding partner to the ligand and, if desired,(b) at least one reagent selected from ligand analogues and specific binding, partners,at least one of the said components (a) and (b) being labelled with an electron-donor or electron-acceptor,and determining whether (and, if desired, the extent to which) transfer of electrons between the said electron-donor or electron-acceptor label and a suitable charge-transfer partner resulting in charge-transfer complex formation is perturbed by ligand complex formation and/or by controlled external influences.

Abstract: Diluent and wash compositions are useful in a rapid and sensitive assay for detecting antibodies, and especially retroviral antibodies, in a biological specimen. The diluent composition is buffered to a pH of 6 to 10 and includes a protein or carbohydrate, a surfactant and a negatively-charged organic compound. The wash composition is buffered to a pH of 5 to 10 and includes a surfactant. These compositions can be included in a diagnostic kit. The method of this invention includes mixing the biological specimen with the diluent composition, forming an immunological complex between ligand and antibodies in the specimen and separating complexed materials from uncomplexed materials using a filtration membrane and a washing step. An enzyme labeled anti-antibody is added to form a ligand-antibody-antibody complex followed by its detection using suitable reagents.

Abstract: Dideoxynucleotide DNA sequencing methods can be dramatically improved by utilizing the DNA polymerase from Thermus aquaticus to catalyze the primer extension reactions.

Abstract: Highly uniform microbeads containing a single fluorescence dye or a mixture of fluorescence dyes, which can be excited over a wide range of the spectrum extending from the ultraviolet to the infrared, and which can be used to align a flow cytometer or fluorescence microscope.

Abstract: A method for determining the presence of a specific binding member bound to first particles in a liquid medium is disclosed. The method comprises providing in combination (1) a liquid medium suspected of containing a specific binding member bound to first particles, (2) means for agglutinating the first particles in relation to the presence of the specific binding member, and (3) second particles having the same or a different specific binding member for said means for agglutinating bound thereto, thereby providing for said means to agglutinate the second particles. Agglutination of the first and second particles are separately detectible and distinguishable by spectroscopic measurement. The medium is incubated and agglutination of each of the particles is determined spectroscopically without separating the first and second particles.

Abstract: Monoclonal antibodies and compositions thereof are provided for detecting, measuring, and immunopurifying human GM-CSF.

Abstract: Chemically synthesized polypeptides containing about 6 to 40 amino acid residues and having amino acid residue sequences that substantially correspond to the primary amino acid residue sequences of particular variable or hypervariable regions of immunoglobulins, when administered alone or as polymers or as conjugates bound to carriers, induce the production of anti-idiotype antibodies of predetermined specificities.

Abstract: This invention relates to a method of simultaneously determining DNA sequence variations on a large number of loci, and a kit suitable therefor. The method comprises an electrophoretic separation of restriction fragments in two dimensions on the basis of two independent criterions, namely, length and base pair sequence, and a detection of separated fragments by means of a labelled probe comprising one or more units of minisatellite sequences. Preferred probes are GC-rich minisatellite core sequences.

Abstract: The potential fertility of a semen sample is evaluated using a kit comprising a collection tube with volume gradients on its side; a funnel which is fitted into the collection tube for guiding an ejaculate into the collection tube; a pipet containing a standard aqueous solution of the dye resazurin stored therein for metering a predetermined amount of the solution into the collection tube; and insulating sleeve for surrounding a glass containing hot water and the collection tube and for maintaining the water at an elevated temperature for a predetermined period of time, and a color chart ranging in color from the color of the semen sample and dye solution mixture immediately after mixing to the color of a corresponding mixture of the dye solution and a highly fertile semen sample, after being maintained at the same elevated temperature for the same period of time.

Abstract: The invention concerns an immunological assay system, wherein the inner face of the cuvettes is used as the solid phase. The equipment includes a displaceable carriage (8) for the cuvette set as well as, above the carriage, a dosage head (9), to which the liquid dosimeter (11) and the measurement device (19) are attached. All the operations take place automatically.

Abstract: The invention relates to monoclonal antibodies against prosomal proteins of a prosome, said prosome having a sedimentation coefficient of approximately 19S, and to a method for detecting cancer using monoclonal antibodies specifically directed against said prosomal proteins. The invention also relates to diagnostic reagents for use in such a detection method.

Abstract: An agglutination method for the detection of antibodies against streptococcal deoxyribonuclease B is described, in which carrier-bound antibodies against streptococcal DNase B are mixed with a solution of streptococcal DNase which contains a protease inhibitor, and the sample in which the antibodies are to be detected, as well as an agent suitable for this method.

Abstract: A device for performing immunoassays which has an external housing, a sample container provided with reagents that can be inserted into the external housing, a material container for an absorbent material and membrane-bound antibody or antigen that can be inserted into the sample container, a holder for the material container that can be mounted on the external container, and a spacer that can join the holder and the sample container. When the spacer is in place, the absorbent material is held above the portion of the sample container that holds the sample and when the spacer is removed, the absorbent material is lowered into the sample-containing portion of the sample container. The external housing may also include a container for developer.

Abstract: The present invention describes a monoclonal antibody that is directed against an Apo AI/HLD epitope whose expression is substantially unaffected by deamidation. Also disclosed is a polypeptide capable of immunologically mimicking an Apo AI/HLD epitope whose expression is substantially unaffected by deamidation. Diagnostic systems and methods for determining the amount of Apo AI in a vascular fluid sample using a disclosed monoclonal antibody and/or a disclosed polypeptide are also described.

Abstract: A specimen kit for collection, preservation and dispatch of smear specimens collected on a glass slide makes use of a single sheet of package material having short fold-over panels at opposite end edges and long fold-over overlapping panels at the side edges, in this way to form a relatively long flat package. Transversely extending lines of perforations make possible separating the long flat package into one relatively shorter reusable package with opposite end panels and a throw away sheet. One of the end panels of the shorter reusable package has a specially formed retainer for securing a transparent specimen slide in place. The panel is additionally provided with a window through which is revealed information pertaining to the specimen on the slide.

Abstract: A specific binding composition comprises a specific binding species and one or more water-soluble proteins or carbohydrates, substantially none of which has a pI greater than about 5. This composition provides improved sensitivity with lower background in diagnostic tests. Preferably, the species is labeled for detection, for example, with an exzyme. The composition can be included with a dye-providing composition in a diagnostic test kit for use in diagnostic methods.

Abstract: A kit and method have been developed which can be used to simultaneously detect antibodies to two HTLV or HIV antigens. The kit includes a solid carrier material, such as a microtest plate, having immobilized thereon a mixture of first and second viral antigens. The antigens are from any of HTLV-I, HTLV-II, HIV-I and HIV-II provided, however, that HTLV-II antigen is mixed only with HTLV-I antigen. The kit also comprises labeled-antibodies which are reactive with both the first and second antibodies in a test sample. A biological sample, such as a blood sample, is assayed by contacting it with the immobilized antigens to form reaction products between the immobilized antigens and the antibodies in the sample, followed by contact with the labeled antibodies to form labeled reaction products which can be detected in a suitable manner. The kit and method are useful for rapid screening of biological fluids.

Abstract: An apparatus for chemically analyzing a sample on a test piece that includes a reagent layer, comprises a test piece table for positioning a test piece thereon, and an applying station wherein a sample may be applied to the reagent layer. The test table moves to a position below a row of holes with the reagents aligned to the holes and a sample is applied to each reagent layer from a nozzle, the samples passing through the respective holes. Covers are moved over the holes after the samples are applied and the test pieces are moved to a measuring station for measuring the reaction between the sample and reagent layer. Photometric techniques are used in evaluating the reaction. Opening and closing of the covers is controlled by motion of the sample dispensing nozzle as it moves from one opening to the next.

Abstract: A method and a test kit for rapidly determining the presence of functional cellular steroid receptors by assaying a tissue sample for nuclear steroid or antisteroid binding is disclosed which comprises treating the tissue with collagenase, incubating the isolated cells with a labelled steroid or a labelled antisteroid capable of complexing said receptors and measuring the bound nuclear radioactivity and the DNA of the isolated cellular nuclei.

Abstract: Disclosed are monoclonal antibodies which react with human tumor cells, particularly metastatic human tumor cells, but not with normal human tissues tested. The monoclonal antibodies are prepared against a 580 kilodalton glycoprotein antigen, designated gp580, which is isolated from either rat or human tumor cells. Methods for isolating the glycoprotein antigen are disclosed as well. Moreover, techniques are disclosed for utilizing these antibodies both in the detection and in the prevention of human tumor lesions.

Abstract: A generally tubular container integrally formed and communicating with a microscope slide member having an enclosed specimen chamber. The container is adapted to serve as a centrifugation tube and a permanent handle for manipulation of the microscope slide member. The back of the device is generally flat and the front and sides of the collection tube are generally rounded except for a concave region extending longitudinally from the upper face of the microscope slide member to provide clearance for rotating a lens turret for high power viewing of a specimen in the slide chamber.

Abstract: For the serodiagnosis of a fluid sample, it is particularly advantageous to use a device comprising (A) a supported, porous membrane wherein a first immunoreagent is bound so as to be capable of binding a foreign analyte and forming a complex when the foreign analyte is brought into contact therewith; and (B) a matrix which presents a first surface and an opposing second surface and which contains a second, labeled immunoreagent that is capable of binding the foreign analyte to form a labeled complex when the foreign analyte is sandwiched between the first immunoreagent and the second immunoreagent. In such a device, the first surface of the matrix is adjacent to a surface of the membrane, (ii) the matrix is wettable by or soluble in an aqueous fluid, and (iii) the second immunoreagent is mobilized when the matrix is wetted.

Abstract: A dye-providing composition comprises a water-soluble or -dispersible polymer, such as a vinylpyrrolidone polymer, and an imidazole leuco dye capable of providing a dye in the presence of hydrogen peroxide and a peroxidative substance. The weight ratio of polymer to leuco dye is from about 10,000:1 to about 100:1. The dye-providing composition can be included with a peroxidase substrate in a diagnostic test kit. A method for the determination of a ligand can be carried out using a peroxidase labeled-receptor for the ligand and the dye-providing composition described above. The method is particularly useful for the determination of human chorionic gonadotropin (hCG).

Abstract: A high molecular hyaluronic acid which is an important factor in the diagnosis of inflammations such as rheumatism or diseases such as cancer is assayed as a complex of sandwich structure in which a hyaluronic acid binding protein is coupled to the hyaluronic acid of interest at two or more sites of binding without the need to employ a competitive reaction as in the prior art techniques of assay. The assay method of the present invention does not require a purified form of hyaluronic acid as a reagent and permits as small as 10 ng of a high molecular hyaluronic acid to be detected or quantified by a very simple operation.

Abstract: Methods and compositions are provided for detecting antigens having a specific epitope associated with squamous lung carcinoma. The antigen may be found at lesion sites or in the blood as indicative of the squamous lung carcinoma.Specific antibodies may be used for the detection of the antigen and in therapy.The mouse hybridoma 43-9F producing IgM monoclonal antibody 43-9F and SLC cell RH-SLC-L11 were deposited at The PHLS Centre for Applied Microbiology and Research, Porton Down, Salisbury, U.K. on Jan. 31, 1985 and given Accession Nos. 85013101 and 85061403, respectively.

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: This invention relates to a flotation immunoassay employing a novel buoyant matrix to which an antigen or antibody is coupled and which separates the bound and free products of the assay by floating to the surface of the reaction liquid. The novel flotation device which makes it possible to detect and to quantitate either antigen or antibody can also be used to fractionate cells and molecules.

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: Disclosed are immunological methods and materials for detection of antigens associated with breast or prostate cancer disease states. Presently preferred antibody preparations (e.g., PR92 monoclonal antibodies produced by hybridoma cell line ATCC HB 9390) are employed in immunoassays performed on patient body fluids and for purification of tumor-associated antigen compositions.

Abstract: A two site cross-reaction immunometric sandwich assay method for the detection and measurement of an analyte, such as creatine phospho-kinase-MB, in serum comprising the selection of two different antibodies each of which is specific to a different analyte but each of which will cross-react with the analyte of interest. The first antibody is reacted with the unknown sample utilizing a solid-phase to bind the first antibody. Separation of the solid and liquid portions of the first reaction is accomplished and the solid portion thereof is reacted with the second antibody which is tagged. The solid portion and liquid portion of the second reaction are separated and the solid portion is tested for the tag as an indication of the presence of said analyte. With particular reference to testing for creatine phospho-kinase-MB in human serum, the cross-reacting antibodies utilized are antibody to creatine phospho-kinase-BB and creatine phospho-kinase-MM.

Abstract: A method is disclosed for discriminating between cattle vaccinated against and those infected with Brucella spp. The method involves immunoassay using a purified polysaccharide containing 4,6-dideoxy-4-acylamido-D-mannopyranosyl units obtained from B. abortus or from cross-reacting organisms, and results in improved differentiation between vaccinated and infected animals. Test kits are also disclosed for performing the assay and a process is disclosed for obtaining the O-chain polysaccharides in high purity and yield.