Abstract: Detection of sialylated Lewis.sup.x antigen in sera is employed as diagnostic of the presence of cancer. Conveniently, monoclonal antibodies are provided which are shown to be useful in the diagnosis of a neoplastic condition, with a wide variety of different tumors.The hybridoma CSLEX1 was deposited at the A.T.C.C. on June 20, 1984 and given Accession No. HB8580.

Abstract: A method for the isolation and quantitative detection of a selected single-stranded target polynucleotide from solution. The target polynucleotide is hybridized in solution to a single-stranded mediator polynucleotide, a probe polynucleotide, and an immobilized polynucleotide sequence. The sequence of the mediator polynucleotide comprises a first sequence complementary to a first portion of the target polynucleotide sequence and a second nucleotide sequence complementary to a portion of a single-stranded immobilized polynucleotide sequence. The probe polynucleotide, which carries a detectable label, is complementary to a second portion of the necleotide sequence of the target. The immobilized polynucleotide is immobilized by attachment to a solid support, and, through hybridization to the mediator polynucleotide, functions to immobilize the entire immobilized polynucleotide/target polynucleotide/probe polynucleotide "sandwich".

Abstract: The invention provides a reagent and assay to detect, inter alia anogenital warts, cervical intraepithelial neoplasia and invasive squamous cell carcinoma of the uterine cervix using disrupted Papillomavirus virions or antigen extract thereof.

Abstract: A method is provided for determining the presence in a sample of a member of a specific binding pair ("sbp member") consisting of ligand and its homologous receptor. The sample is combined in an aqueous medium with (1) a complementary sbp member wherein at least the sbp member or the complementary sbp member is bound to the surface of a cell and (2) a fuorescent agent capable of being incorporated into the cell. The presence of the sbp member is indicated by a change in fluorescence of the unseparated cell suspension as a result of agglutination of the cells.The present invention has particular application to blood typing, for example, for the determination of the presence of blood group antigens A, B, AB, O, and D (Rh.sub.o) and antibodies to such antigens.

Abstract: Regression associated antigens are identified in material from neoplastic cells by their immunological reactivity with regression associated antibodies from the serum of patients diagnosed as undergoing regression of a tumor. Regression associated antibodies are identified by their absence during progression of a neoplastic disease state and by their presence in a diagnosed state of regression. The antigens are purified, used to monitor the condition of cancer patients, and production of antibodies and treatments employing those antibodies are described.

Abstract: The invention relates to a test strip for taking of daily blood sugar profiles, and also for glucose determination in urine for determining the individual kidney threshold of a diabetic as a daily profile, which finds use in glucose diagnosis.The objective of the invention is to stabilize the test strip in its function and to adapt it to customary measuring instruments, and this is achieved by attaching a film reaction membrane to a carrier, wherein the membrane was post treated with a complexing agent and an acyclic hydroxyamine or amino derivative.

Abstract: A stable substrate formulation for an alkaline phosphatase assay includes 5-bromo-4-chloro-3-indolyl phosphate, nitro blue tetrazolium and a 2-amino-2-methyl-1-propanol buffer. Addition of MgCl.sub.2 to this formulation promotes stability.

Abstract: Certain substituted benzo- and naphthoquinone electron transfer agents are useful in analytical compositions, elements and methods, e.g. for determinations of living cells. These electron transfer agents are capable of being reduced by an analyte, and the reduced electron transfer agent, in turn, reduces another compound providing a detectable species (e.g. a dye). The reduction potential (E.sub.1/2) of the electron transfer agents useful inthis invention is in the range of from about -320 to about +400 mV as measured in an aqueous buffer solution at pH 7.

Abstract: An immunoassay device includes one or more reaction chambers. Each reaction chamber is adapted to receive and retain a volume of test fluid in fluid communication with nonoverlapping first and second reaction surfaces. To the first reaction surface is immobilized analyte binding partner that is in turn saturated with analyte conjugate: analyte component conjugated to one or more components, termed ligand/marker, that serve ligand and marker functions as described herein. The analyte conjugate has a higher disassociation constant with reference to the immobilized analyte binding partner than does the analyte to be assayed. To the second reaction surface is immobilized ligand/marker binding partner.A test fluid sample is introduced into the reaction chamber and retained therein to permit two reactions to occur. In a first reaction between analyte and analyte binding partner at the first reaction reaction surface, analyte proportionately displaces analyte conjugate into the test fluid sample.

Abstract: A fused protein for use in an enzyme immunoassay system. The protein comprises an enzymatically active .beta.-galactosidase fused, at its C terminus, to an immunologically active peptide. The protein is produced using a plasmid containing a complete .beta.-galactosidase gene fused, at its 3' end, with an oligonucleotide coding for the peptide. The fused protein is designed for use in a solid-phase enzyme immunoassay system, based on immunospecific binding of the fused protein to a solid support, or in a homogeneous enzyme immunoassay system, based on enzyme inhibition resulting from immunospecific binding of an antibody to the protein.

Abstract: A small enzymically inactive peptide fragment of an enzyme (e.g. ribonuclease S-peptide) is used as the label and conjugated with the complementary fragment (S-protein) to form an enzyme which catalyzes a primary reaction whose product is, or leads to, an essential coenzyme or prosthetic group for a second enzyme which catalyzes a secondary reaction leading to a detectable result indicating the presence of analyte. Also disclosed are novel synthetic substrates for the primary reaction. Substrates for ribonuclease S conjugate enzyme are of the formula R-X where R is a pyrimidine 3'-phosphate moiety and X is a leaving group linked to R through the 3'-phosphate group and leads to said coenzyme or prosthetic group, e.g. via riboflavin, thiamine, pyridoxal, pyridoxine or pyridoxine phosphate.

Abstract: A cap for a container in which immunoassays are performed includes a liquid absorbing material accessible to liquid in the container.

Abstract: A novel method is disclosed for the purification of monoclonal antibodies from antibodies of the same isotype but different light chain composition which are frequently present in the fluids in which such antibodies are generated. According to the method, the mixture is placed in a hydroxylapatite chromatography column and eluted with a buffer solution in a concentration gradient elution. With the appropriate optimization of system parameters, a separation of antibodies effective for both analytical and preparative purposes is obtained.

Abstract: A method of measuring the concentration of a free ligand in a biological fluid containing the free ligand and ligand bound to endogenous binding agent, by the steps of(a) mixing a sample of the fluid with an analogue of the ligand, a specific binder with which the free ligand and the ligand analogue bind, and an exogenous binding agent which binds the ligand analogue but not the ligand, either the ligand analogue or the specific binder being labelled,(b) incubating the resulting mixture,(c) determining either the amount of the labelled analogue bound or the amount of labelled specific binder bound, or not bound, to the ligand analogue, and(d) correlating the determined amount to the amount of free ligand present in the sample.The method is useful to measure concentration of free thyroid hormones and other hormones in body fluids, employing antibodies specific to the ligand analogue as the exogenous binding agents.

Abstract: Solid phase assay for an analyte wherein binder is supported on a solid support, such as nitrocellulose, and the tracer is comprised of ligand labeled with a particulate label, such as a liposome, including a detectable marker which is not visible.

Abstract: A method is provided for substantially increasing the dynamic range of an immunoassay and forestalling the hook effect observed with very large ligand concentrations in aqueous samples. The method comprises the addition of ligand binding partners which do not have labels associated therewith to compete with labeled ligand binding partners thereby effectively eliminating the presence of the excess ligand in the sample solution. The conversant method for ligand binding partner immunoassays is also provided.

Abstract: A luminescent substrate preparation having a concentration of catalytic inhibitors of less than about 100 ppm. The preparation is obtained by heating commercial grade luminol in a basic solution, crystallizing the luminol and separating the luminol crystals from the boiled solution. The heating, crystallization and separation steps are preferably repeated sequentially at least four times, with the starting material for each sequence after the first being the luminol preparation produced in the previous sequence. The luminol preparation has an enhanced pattern of activity, in that light output is substantially constant over a period of at least about one hour, with the intensity of light emitted by the preparation being at least about ten times that of commercially available luminol. Because of these enhanced characteristics, the luminol preparation is particularly adapted for use as a tag in specific binding assays where the concentration of analyte to be detected is low.

Abstract: An improved method and reagents are disclosed for determining a ligand in an assay solution containing the ligand, a reagent system and a luminescent compounds, wherein the intensity of the light emitted by the assay solution is related to the change in the transmittive properties of the assay solution produced by the interaction of the ligand to be determined and a reagent system capable of producing a change in the transmittive properties of the assay solution in the presence of the ligand.

Abstract: Actinobacillus actinomycetemcomitans has frequently been implicated in juvenile periodontitis. The present monoclonal antibodies are specific to Actinobacillus actinomycetemcomitans. The present monoclonal antibodies are typically employed as reagents which include an inert carrier, preferably a liquid, such as buffered saline solution and a preservative. The carrier compositions are suitably selected to provide for the proper dispersal of bacteria, and to preserve the integrity of antigens and supplemental structures. The selection of the proper carrier is especially important in the detection in mixtures which include bacteria which produce large amounts of autolyltic enzymes such as B. gingivalis. The monoclonal antibodies of the present invention are useful in clinical testing and differentiating antigens in the gingival or subgingival sera.

Abstract: The present invention relates.Iadd., inter alia, .Iaddend.to improvements in the sandwich technique for the determination of a component of an antigen-antibody reaction in a liquid sample to be tested, utilizing as reagents (a) one component of said reaction bound to the surface of a water-insoluble, water-insuspensible, solid carrier, and (b) a component having the same immunological properties covalently linked to an enzyme. .Iadd.If and only if the component of the reagent that is water-insoluble and water-insuspensible has the same immunochemical properties as the component to be determined, is a predetermined amount of a binding partner for said first reagent (e.g., the reagent that is water-insoluble and water-insuspensible) added to the liquid sample. .Iaddend.The liquid sample is contacted and incubated with the reagent(s) to form a reaction mixture, the enzyme activity of either the liquid or solid phase of which is a measure of the presence and quantity of the component to be determined.