Abstract: A chromatic test device for the performance of immuno- or chemical assays wherein a unitary planar fibrous filter body incorporates a sample application zone, a separation zone and a reaction zone and the application zone is in fluid communication with a first absorbent and the reaction zone is in fluid communication with a second absorbent to establish bilateral flow of the fluid component of the sample and of the analyte applied to the zones during the performance of an assay.

Abstract: Am improved device and method for analyte assay in liquid samples, wherein a porous membrane with an immobilized receptor which is capable of directly or indirectly binding to the analyte is separated from a body of absorbent material capable of absorbing the liquid sample by a septum capable of substantially separating the porous membrane from the absorbent body while substantially directing the flow of the liquid sample from the porous membrane to the absorbent body.

Abstract: A method is provided for sequencing nucleic acids without the need to separate similarly sized DNAs or RNAs by gel electrophoresis. The method relies on the separate hybridization of multiple mixed oligonucleotide probes to a target sequence. The mixed oligonucleotide probes comprise sequences of fixed and non-fixed bases corresponding to every possible permutation of fixed and non-fixed bases less than or equal to the length of the probes. For each probe, the hybridizations provide the number of times the probe's particular sequence of fixed bases appears in the target sequence. The target sequence is then mathematically reconstructed from this data and a knowledge of the probe sequences.

Abstract: The invention describes a method for determining the BZ-1 receptor activity of a test sample or a potential anxiolytic drug.

Abstract: The invention concerns a probe for the detection of shigellae and entero-invasive E. coli, containing a nucleic acid sequence originating from the 140 Mdal virulence plasmid of the M 90 T strain of Shigella flexneri; having a maximum size of around 27 kb and including all or part of the 27 kb Bam HI fragment.This probe permits the in vitro diagnosis of syndromes of dysentery or diarrhea, of the Shigellosis type.

Abstract: A receptor preparation of biologically active receptor material is produced in which a cell membrane preparation is lyophilized accompanied by the addition of sugars and/or amino acids and/or proteins. A radioreceptor assay can be produced therefrom, which contains the colyophilizate of cell membrane together with sugar compounds and/or amino acids and/or proteins, as well as a tracer substance and a comparison standard substance. A radioreceptor assay kit uses the radioreceptor assay by making available the substances in a plurality of test containers containing a colyophilizate suitable for the assay.

Abstract: A biologically or chemically active substance is incorporated in a unitary body with a magnetically responsive material for carrying out a specific biological or chemical procedure. This may be microbiological, immunological, serological or other biochemical examinations. The body is applied against a substrate or medium by application of an external magnetic field and a reaction region is produced at the site of the body and is measured by a reader. The magnetically responsive material is provided in a form distributed in the body so that application of the external magnetic field will be applied substantially uniformly on the body. The distributed form of the magnetically responsive material in the body corresponds substantially to the shape of the body.

Abstract: Magnetic separation devices are described for use in immunoassay or hybridization assay procedures. The most preferred embodiments comprise a defined relationship between microtube and microtiter plate receiving orifices and rare earth cobalt magnets having predetermined magnetic field orientations.

Abstract: An immunoassay test device is disclosed with dried reagent drops applied to a sloping side wall of a reaction wall. A method of applying them as liquid drops is also described, wherein the slope of the side wall, and the composition and volume of the liquid drop are selected to insure that the liquid drops do not flow down to the bottom of the well.

Abstract: A method and kit for determination of subsets of leukocytes utilizing flow cytometry analysis techniques.

Abstract: Purified glomerular proteoglycans are used as a basis for a diagnostic test for glomerulonephritis in humans involving an immunological reaction between the purified proteoglycans and patient area. A new method for purification of glomeruli proteoglycan antigens is described using guanidine extraction.

Abstract: A blood sample is prepared by combining a fluorescently tagged monoclonal antibody with blood cells. The sample is then passed through a flow cytometer and light scattered by each blood cell in two directions is sensed simultaneously by a single sensor. Lymphocytes are discriminated from other cells by using an intensity distribution of the total scattered light. Then, by using a distribution of fluorescent light intensity of each cell thus discriminated, the cells in a lymphocyte subclass of interest are enumerated with a high accuracy. The data acquired are utilized in diagnosing immunological incompetence or the like.

Abstract: Liquid containers or receptacles are disclosed with cooperating means for rupturing the receptacles to release contained fluid to rain upon test specimens. Structure is disclosed for rupturing receptacles in response to relative motion occurring between receptacles and test specimen support members or in response to punch means formed integrally with a receptacle. A method of molding a liquid receptacle with an integrally formed punch means for rupturing the receptacle is also disclosed.

Abstract: In a method for fluorescence immunoassay of an analyte, an antianalyte attached to the surface of a solid support is contacted with the analyte and a tracer which includes a substantially water insoluble fluorescent dye occluded in the nonaqueous portion of a sac. After binding reactions involving the antianalyte, analyte and tracer, the solid support is separated, excitation light is applied and fluorescence from dye in intact sacs bound to the solid support is measured and compared to fluorescence measured when known quantities of analyte are assayed. The invention includes a kit of materials useful in performing an immunoassay in accordance with the method of the invention.

Abstract: An immunoenzimatic method is disclosed for the detection and the measurement of anti-P. falciparum sporzoite antibodies in human blood and/or in its derivatives, which operates with a synthetic antigen-enzyme conjugate capable of forming with the antisporozoite antibodies a stable antibody-synthetic antigen-enzyme complex, and one or more proteins absorbed and/or covalently linked to a solid support, which eagerly bind the antisporozoite antibody of said complex.The method, thanks to its simpleness, specificity and rapidity, is particularly useful in epidemiologic investigations into malaria and into the efficacy of an antimalarial vaccine.

Abstract: An analytical method for determining the relative amount of a particular hemoglobin derivative, e.g., glycated hemoglobin, in a blood sample wherein the amounts of both total hemoglobin and the hemoglobin derivative are measured and related mathematically, e.g., as a percentage. The blood sample is treated with the combination of a thiocyanate salt and an oxidant to denature the hemoglobin in the sample and to convert hemoglobin to met-hemoglobin. Met-hemoglobin is measured spectrophotometrically to give the amount of total hemoglobin present, and the denatured hemoglobin derivative can be distinguished and measured by immunoassay. The presence of the oxidant in the denaturant solution has been found to increase the rate of enaturation of hemoglobin thereby reducing the overall assay time and improving the reliability of the determination.

Abstract: Assay methods and test kits for detection of antibodies having specificities for a variety of determinants in patient samples are disclosed. The assay is especially suitable for use in evaluating patients for their suitability to receive diagnostic and therapeutic immunoconjugates comprising immunoglobulin constituents derived, at least in part, from a non-human source. The assay methods and test kits utilize a target substance (e.g., immunoglobulin) which has substantially the same binding characteristics as a portion of the immunoconjugate proposed for in vivo administration. A plurality of target substance densities are used for assaying each patient specimen to provide an indication of both the level and relative affinity of circulating antibody capable of binding to the immunoconjugate proposed for treatment.

Abstract: An aqueous wash solution is buffered to a pH of from about 5 to about 9 and contains at least about 1.5 weight percent of a compound comprising a lower alcohol sulfate anion having from 6 to 10 carbon atoms and an alkali metal or ammonium cation, such as sodium decyl sulfate. This wash solution is useful in a method for the determination of an immunological ligand, and is not prone to crystallization at lower temperatures. 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: A disposable, pre-packaged device is particularly suitable for conducting diagnostic procedures based on immunological reactions using specimens gathered in the absorbent tip of a swab. The device is made up of an elongated holder member which includes structure for supporting and positioning a swab, another holder member hingedly mounted at one end of the swab holder member and which carries a capture media element assemblage suitable for conducting an immunoassay test. The device also includes a cover member hingedly mounted on the opposite end of the swab holder member. The cover member includes structure positioned for pressing the swab tip against the capture element when the device is operated. Thus, the light in the swab tip is squeezed and the test fluid is expressed therefrom and brought into intimate contact with the capture element. The results of the test are visually observable by simply swinging the member which carries the capture element away from the swab holder member.

Abstract: The invention relates to a kit for detecting the presence of a nucleic acid sequence, such as a gene or a gene fragment, in a composition or a specimen supposed to contain it. The kit comprises a probe containing a nucleic acid complementary with the nucleic acid sequence or gene which is sought. The probe bears at least one 7-iodo-N-2-acetylamino-fluorene group covalently fixed at one at least of the bases of this probe.

Abstract: A simplified detection implement for use in the biological or chemical tests such as medical, pharmaceutical, microbiological, enzymological or analytical tests comprising an adhesive sheet (1) having an adhesion material layer (4), the adhesion sheet (1) also having an area "a" in an optimal shape and an area "b" in an optimal shape with a folding line (6) at the border of areas "a" and "b"; a small test material (3) adhered to the adhesion material layer (4) and being placed approximately at the center of area "a" of the adhesive sheet (1); and a peelable protection sheet (2) covering the surface of the adhesion material layer (4) and having an opening (5) big enough to expose the whole surface of the small test material (3) as well as being so positioned to expose the small test material (3) when areas "a" and "b" are overlapped by folding the adhesive sheet (1) at the folding line (6), and when areas "a" and "b" being overlapped the majority or part of area "a" of the adhesive sheet (1) acts as the adhesi

Abstract: A method for sequencing a strand of DNA, including the steps of: providing the strand of DNA; annealing the strand with a primer able to hybridize to the strand to give an annealed mixture; incubating the mixture with a deoxyribonucleoside triphosphate, a DNA polymerase, and a chain terminating agent under conditions in which the polymerase causes the primer to be elongated to form a series of DNA products differing in length of the elongated primer, each DNA product having a chain terminating agent at its elongated end; the number of each DNA product being approximately the same for substantially all DNA products differing in length from 1 to 20 bases.

Abstract: A gel body is provided with a reagent system which interacts with a sample portion which diffuses into the gel to change the transmissive properties of the gel. The gel body is used in an assay for various analytes, and preferably has a shape and index of refraction whereby a beam of light can be transmitted through the gel body by total internal reflectance.

Abstract: An immunoassay method for one-step detection of specific antibodies which includes incubation of a solid phase support or matrix having a spot of the antigen bound thereto with a sample of the clinical fluid to be tested in the presence of a signal developing reagent, including a detector substance, which is preferably a colloidal metal sol, and a ligand, such as protein A or other antibody binding ligand. A diagnostic field kit containing the test antigens and signal developing reagent is also described.

Abstract: Agglutination assays, particularly latex agglutination assays, for simultaneous testing for a multiplicity of ligands. The reagents for use in the assays comprise two or more insoluble colored substances, each substance being adapted to form a distinctively colored agglutinate in the presence of a specific ligand or specific group of ligands.

Abstract: Agglutination assays, particularly latex agglutination assays, for simultaneous testing for a multiplicity of ligands. The reagents for use in the assays comprise two or more insoluble colored substances, each substance being adapted to form a distinctively colored agglutinate in the presence of a specific ligand or specific group of ligands.

Abstract: Agglutination assays, particularly latex agglutination assays, for simultaneous testing for a multiplicity of ligands. The reagents for use in the assays comprise two or more insoluble colored substances, each substance being adapted to form a distinctively colored agglutinate in the presence of a specific ligand or specific group of ligands.

Abstract: An assay method and kit in which particles bearing a first reagent binding pair member (e.g., anti-digoxin antibody) react with a sample such that analyte binding pair member (e.g., digoxin) binds to the first reagent binding pair member. The reaction mixture is then passed through a filter or membrane or pore size sufficient to allow particles to pass through. A second reagent binding pair member (e.g., digoxin-albumin conjugate) is immobilized on the filter or membrane to trap preferentially either particles which have bound analyte binding pair members or particles which have not, leaving the other class of particles to pass through the filter for detection by resistive pulse techniques, by light absorbence or scattering, by enzymatic read-out (when the particles are enzyme-labeled) or otherwise.

Abstract: A method of performing a diagnostic immunoassay utilizing colloidal non-metal particles having conjugated thereto a binding component capable of specifically recognizing an analyte to be determined. After reaction of the sample and colloidal non-metal particles, the presence or amount of analyte/colloidal non-metal particle complexes are determined by optical analysis as a measure of the amount of analyte in the sample. The method can be utilized for the specific detection of numerous analytes and is sensitive and has a wide detection range.

Abstract: A micro-enzyme described immunosorbent assay (microELISA) method is described for detecting small amounts of thymosin alpha.sub.1 in a solution such as serum. The method uses a known amount of an antibody to the thymosin alpha.sub.1 which is reacted with the thymosin alpha.sub.1 in solution to form a first complex. The solution with the first complex and unreacted antibody is then contacted with thymosin alpha.sub.1 bound to a solid phase which quantitatively forms a second complex with the unreacted antibody. The amount of the second complex is determined and correlated with the amount of thymosin alpha.sub.1 of the solution. Thymosin alpha.sub.1 is an important hormone the presence or absence of which is significant clinically.

Abstract: A filter providing at least two different filtering pore sizes for coarse and fine filtering, and a kit containing such filter along with an immunoassay test device containing a membrane. The membrane is used to separate bound immunoassay labels from free labels. The coarse and fine filtering are provided preferably by two different, serially arranged filters, the filter with the fine pore size being selected with a pore size similar to that of the membrane of the assay device.

Abstract: Novel Fc receptors, denoted type VI, are disclosed as reacting with rat immunoglobulins with a reasonable affinity. These receptors, or the microorganisms which produce them, are useful in immunoassays.

Abstract: A method and apparatus for conducting specific binding pair assays, such as immunoassays, is described. A porous membrane capable of non-bibulous lateral flow is used as assay substrate; a member of the binding pair is affixed in an indicator zone defined in the substrate. The sample is applied at a position distant from the indicator zone and permitted to flow laterally through the zone; any analyte in the sample is complexed by the affixed specific binding member, and detected. A novel method of detection employs entrapment of observable particle in the complex. Blood is a particularly preferred sample as the red blood cells can be used as the observable particles for detection of the complex.

Abstract: The present invention is concerned with novel monoclonal antibodies which bind to Interleukin-1.beta. and do not bind to Interleukin-1.beta.. The antibodies bind to Interleukin-1.beta. and block receptor binding and biological activity. The antibodies find use in, for example, diagnostic methods such as an assay for the detection of Interleukin-1.beta..

Abstract: Detection of bindable substances such as antibodies and antigens using enzyme linked immunosorbent assays having particular utility in home diagnostic applications. The preferred implementation of the invention is characterized by the steps of admixing a sample suspected of containing the bindable substance to be detected with an antibody-enzyme conjugate, immersing an antibody coated solid support into the mixture and then exposing the coated support to an activated chromogenic solution. The conjugate for use in the home diagnostic assay is preferably contained within a lyophilized mixture. The lyophilized mixture contains components which preserve the antibody-conjugate's reactivity and immunologic binding specificity even if the lyophilized mixture had been subjected to hot, humid environmental conditions. Active components in the lyophilized mixture include polyethylene glycol, sugars, and surfactant.

Abstract: Human cancer is diagnosed/monitored by measuring the levels of N-[9-(.beta.-D-ribofuranosyl)purin-6-ylcarbamoyl]-L-threonine (t.sup.6 A), in a physiological fluid specimen of a subject by a quantitative immunoassay that employs a monoclonal anti-t.sup.6 A antibody and comparing that level to the level of t.sup.6 A that occurs in corresponding physiological fluid of normal subjects to determine whether the former is substantially elevated over the latter or by comparing that level to the level of t.sup.6 A present in specimens taken from the subject at different times.

Abstract: An immunoassay method and apparatus for diagnosing FeLV-induced, persistent viremia is provided comprising combining a feline saliva sample conveniently obtained with a specially designed probe, with anti-p27 antibodies and detecting complex formation as indicative of the viremia. Preferably, the antibodies are bound to the probe for complex formation.

Abstract: A new marker for colorectal carcinoma has been discovered which is a glycoprotein having a molecular weight of approximately 160,000 daltons. Assay methods which can identify this marker are useful indetecting, diagnosing, and monitoring colorectal carcinoma, and in particular, carcinoma of the undifferentiated variety which heretofor were not readily detectible. For example, an assay which utilizes an antibody reacting to this glycoprotein marker is useful in a screening method for the detection and monitoring of colorectal carcinoma cells. Such an antibody can be included as part of a kit for screening a patient for colorectal carcinoma.

Abstract: The present invention relates to a 40 kilodalton subunit of serous cystadinocarcinoma ovarian tumor associated antigen CA125, useful in the diagnosis and monitoring of ovarian cancer. It also relates to an immunoassay method for detection of the antigen in serum for diagnosis and monitoring purposes.

Abstract: A flow through test device and assay kit suitable for use by unskilled technicians is described. The flow through device has a porous support and an absorptive layer. The device is constructed for control of flow rates so that a tracer having a visible particulate label can be used. Optional flow control and porous spacer layers may be included.

Abstract: A method of multi-color labeling at least two antigens present in a tissue such as non-liquid tissue or body fluids, with the aid of different antibodies is improved by introducing between the labeling of the first antigen and the labeling of the second antigen, and between labeling of the second and that of any further antigen, at least once a treatment with a non-immune normal serum and optionally other agents blocking any binding sites remaining free in the tissue after a last-preceding labeling step.

Abstract: A specific high molecular weight antigen (gp650) is detected in the sera of cancer patients with gastrointestinal cancer, cancer of the liver, breast cancer, cancer of the lung, cancer of the tongue, fallopian cancer, lymphoma and multiple myeloma. A monoclonal antibody specific for the 650 kD high molecular weight glycoprotein antigen has been harvested from mouse ascites and culture supernatants and used for the detection of antigen in cancer patient sera. Disclosed are (1) the method for preparing the antigen, (2) the properties of the antigen, (3) the method for preparation of the monoclonal antibody, (4) the characteristics and specificity of the monoclonal antibody and (5) a diagnostic kit based upon the specific monoclonal antibody.

Abstract: A novel material and device useful in solid-phase binding assays to determine the presence or amount of an analyte in a test sample, particularly antigens, antibodies, or other ligands or DNA segments. The material and device comprises a reaction site having procedural controls and an analyte binding area capable of being simultaneously contacted by the sample and reagent used in the performance of the assay. The procedural controls and analyte binding areas operate to provide readable results as to the presence or absence of analyte and simultaneously verify the assay procedure and therefore the assay result.

Abstract: Microcapsules labeled with an antigen or antibody contain a liquid containing a fluorescent substance, for example, carboxyfluorescein. The liquid in the microcapsules is prepared so as to have a viscosity different from that of a liquid outside the microcapsules. For example, the microcapsules contain polyvinyl alcohol as a substance for increasing the viscosity. Antigen-antibody reaction is caused by mixing such microcapsules, a sample and a complement, and complement is activated with resulting antigen-antibody complex, whereby the microcapsules are lysed.The reaction mixture is irradiated with exciting light, and the polarization components (I.sub..parallel. and I.sub..perp.) of fluorescence from the reaction mixture are detected. The concentration of a substance to be assayed in the sample is determined by calculating the degree of polarization fluorescence P on the basis of the intensities of the polarization components.

Abstract: Disclosed is a glycoprotein, carcinoma orosomucoid-related antigen, (CORA), which has a binding affinity for carcinoembryonic antigen (CEA). This glycoprotein is a marker for carcinoma, and can be characteried by having a molecular weight of about 46,000-50,000 daltons, an isoelectric point of about 3.0-3.5, a carbohydrate content of about 25-35% by weight, reactivity with antisera raised thereto, and substantially no reactivity with antisera raised to nonspecific cross-reacting antigen (NCA) or to CEA. Also disclosed are a hybridoma which produces a monoclonal antibody to CORA, the monoclonal antibody to CORA, and a device, kit, and method for detecting and monitoring carcinoma.

Abstract: Samples e.g. transfusion blood, are assayed for antibodies to retroviruses, e.g. AIDS virus, using an insolubilized antigen comprising retrovirus antigens bound to globulin, the globulin itself being bound to an inert solid support; and an immunoglobulin which contains specific antibody to the retrovirus antigens and which is labelled with a revealing label, and the soluble phase is then separated from the insoluble phase and the quantity of revealing label associated with either the soluble or the insoluble phase determined.The sue of labelled antibody in competition with test sera for binding on the insolublized antigen permits better identification of antibody containing specimens. The retroviruses may be a human T-lymphotropic retrovirus HTLV-I, II or III or a new retrovirus isolate CBL-1 etiologically related to AIDS.

Abstract: A method for determining the level of infectious bursal disease virus IBDV neutralizing antibody in poultry comprising a labeled monoclonal antibody R63 having the IBDV neutralizing capability of the monoclonal antibody expressed by hybridoma cell line ATCC HB-9490. Monoclonal antibody R63 is specific to all known IBDV strains and serotypes and competes only with itself and other antibodies recognizing the same neutralizing epitope present in poultry sera. In a competition assay, the increase in unbound labeled monoclonal antibody is an indication of the level of IBDV neutralizing antibody present in poultry sera.

Abstract: A method for enzyme immunoassay includes contacting under binding conditions a liquid suspected of containing an analyte, an antianalyte affixed to a solid support and a tracer having an enzyme conjugated thereto. A bound fraction is separated from the liquid and incubated in a second liquid with a masked ligand. The masked ligand is converted by the enzyme on the bound fraction to give free lignad which binds to an antiligand. A signal system, such as a signal enzyme and substrate therefor, or a label-loaded vesicle and vesicle lysing agent, is added to generate a signal used to detect or measure the analyte in the liquid. The invention includes a kit of materials useful in performing the assay of the invention.

Abstract: A method of selectively suppressing the immune system and conferring immunotolerance against a specific antigen by interferring with the L3T4 differentiation antigens on helper T cells is described. Simultaneous administration of a binding moiety specific for the L3T4-equivalent in the subject species and a specific antigen or administration of the antigen subsequent to the binding moiety for L3T4-equivalent within the time required for T-cell recovery results in a diminished ability of the subject to respond immunologically to the antigen, whether or not the subject has been exposed previously to the antigen.

Abstract: Tumor nucleoli were treated with polyclonal antisera to normal human tissue nucleoli to block determinants common to tumor and normal tissue nucleoli. Immunization of mice with these immune-complexes resulted in the development of a monoclonal antibody (FB2) to a novel nucleolar proliferation associated antigen which has a molecular weiThe present invention was made with partial support from Federal funding grants. Subject to these grants, the Government may exercise certain rights in the invention.