Abstract: This invention relates to a highly-sensitive mini-iodinated radioactive hormone tracer which has both initial low iodine-to-hormone molar ratios and low specific activity. This invention also relates to methods for preparing and using such tracers in a radio-immunoassay which takes much less time than used heretofore and to a method of preparing said tracers.

Abstract: Colorectal carcinoma is detected by testing body fluids for the colorectal carcinoma monosialoganglioside identified by monoclonal antibodies produced by fused cell hybrid ATCC HB 8059.

Abstract: An improvement in assaying methods involving biospecific affinity reactions, in which there are used from 2 to 4 reactants, one of which, reactant (I), is labelled with at least one analytically indicatable atom or group and is soluble in the aqueous liquid in which the biospecific affinity reaction is carried out, the reactants forming, by means of biospecific reactions, a conjugate in which labelled reactant (I) is incorporated; and in which assaying methods the analytically indicatable atom or group is assayed in the conjugate and/or in labelled reactant (I), which is not bound to the conjugate. The conjugate that has been formed or labelled reactant (I) not bound to the conjugate is bound covalently to an insoluble carrier or to an insolubilizable carrier, which latter carrier is made insoluble after the covalent binding has been carried out, whereafter the assay of the analytically indicatable atom or group is carried out.

Abstract: A novel purification scheme is described for obtaining two novel and useful forms of bovine glycoprotein (BGP) from bovine erythrocytes, each of which acts as an antigen in testing for the presence of the heterophile antibodies of human infectious mononucleosis.The first, or partially purified, BGP is obtained from crude BGP and contains about 10% by weight of a complex glycoplipid. It forms a single band upon gel electrophoresis at pH 7.0 under specified conditions.The second, or homogeneous, BGP is obtained by removing essentially all of the complex glycolipid. It forms substantially a single band upon gel electrophoresis at pH 7.0 under specified conditions.Both forms may be used to detect or quantify hemagglutination inhibition of a test sample (and hence to determine the presence or extent to mononucleosis infection) in a glass slide test wherein the partially purified or homogeneous BGP is carried on latex or synthetic resin beads.

Abstract: An improved competitive protein binding assay comprising; incubating an analyte in the presence of labeled analyte and a protein binder suitable for competitive binding activity by the analyte and the labeled analyte to provide a mixture having free analyte, free labeled analyte, bound analyte and bound labeled analyte, substantially separating the bound analyte and the bound labeled analyte from the free analyte and free labeled analyte to form a first fraction containing substantially the bound analyte and the bound labeled analyte and a second fraction containing substantially the free analyte and the free labeled analyte by causing a predetermined level of the mixture to flow through a bed of an organo-silane coupled to silica gel, and detecting the labeled analyte of at least one of the first and second fractions to determine the concentration of the analyte by comparison to a reference.

Abstract: A new technique is disclosed for assaying for the presence of invasive cancer. While based on leukocyte adherence inhibition, it is improved by using relatively long lived radio-labeled leukocytes, fractionation of the leukocytes to separately treat T-cells and monocytes and by providing for human plasma or serum in the incubation medium.

Abstract: The present invention relates to a new technique and device for mass transfer of one or more components from one liquid phase to another liquid phase, involving a physical separation of said two phases.According to the new technique, the mass transfer and physical separation are carried out in the same device. The device consists of a mixing-reservoir into which is fitted snugly a mixer-separator, having a channel in the vertical axis of the mixer-separator. The two substantially immiscible liquid solutions are introduced into the mixing reservoir, the phases are thoroughly mixed, by moving the mixer-separator in and out the mixing reservoir. After the spontaneous separation into an upper and lower phase, the upper phase is removed by pushing in the mixer-separator said upper phase being accumulated in a collecting container.

Abstract: An improved immunoassay technique for determining the presence of estriol in human sera comprises adding preselected amounts of a non-ionic detergent and a surface active agent to the assay medium to lessen inaccuracies resulting from variable serum protein concentrations in the sample.

Abstract: A method and reagent kit means are provided for assay of a selected hapten in an aliquot of body fluid containing lipid. The method comprises the steps of constituting the aliquot in a mixture with surfactant and incubating the mixture to solubilize the same. The content of hapten in the incubated mixture is taken up selectively by hapten-specific antibody and read by hapten non-lipid conjugate tracer assay.

Abstract: Disclosed is a technique for screening populations to detect potential bladder cancer patients. The screening test is based on a discovered correlation between the respective ratios of C-reactive protein to total protein in urine and serum and the incidence of bladder cancer.

Abstract: A prostate antigen distinct from prostatic acid phosphatase has been detected in normal, benign hypertrophic and malignant prostatic tissues, but not in other human tissues. The prostate antigen was purified to homogeneity from prostatic tissues by ammonium sulfate precipitation, DEAE-BioGel A anion exchange chromatography, molecular sievings on Sephadex G-100 and Sephadex G-75, and preparative polyacrylamide gel electrophoresis. The purified prostate antigen shows a single protein band on analytical polyacrylamide gel electrophoresis and isoelectric focusing. The molecular weight of purified antigen was estimated by Sephadex G-75 gel filtration to be 33,000 and by sodium dodecyl sulfate polyacrylamide gel electrophoresis to be 34,000 with no subunit. The prostate antigen had an isoelectric point of 6.9.

Abstract: Pancreas specific protein systems, including Pan Ag purified antigen having molecular mass of about 2.25.times.10.sup.5 daltons and pancreas specific antibodies to such antigen, and methods for providing and utilizing such antigen and antibodies.

Abstract: This disclosure relates to assay of a glycoprotein component of human breast gross cystic disease fluid which has been designated GCDFP-15. This material is a useful marker in monitoring the efficacy of therapy in women with metastatic breast carcinoma and also in determining the maturity of the fetus in pregnant women. The assay for GCDEP-15 can also be used in conjunction with other assays for breast carcinoma such as an assay for carcinoembryonic antigen (CEA) whereby the utilization of both tests is more effective in monitoring for recurrence of disease than using either assay alone.

Abstract: Novel oligopeptide used as reagents or in the preparation of reagents in relation to gamma-carboxyglutamic acid-containing protein of bone. Particularly, labeled oligopeptides and antibodies prepared from immunogen conjugates are disclosed for use in immunoassays.

Abstract: Radioimunoassay methods for determining the concentration of fibrinopeptide A in plasma, anticoagulation reagents for use in such methods and package test kits containing the reagents for use in such methods are provided.

Abstract: An improved immunoassay for detecting cannabinoids is described. This immunoassay is characterized by utilizing, as reagents, antibody, .sup.125 I-radiolabeled antigen, an unlabeled antigen and an anion exchange resin for separation of labeled and unlabeled antigen. The iodinated tetrahydrocannabinol moiety is stabilized by the addition of small quantities of antioxidants such as butylated hydroxy toluene.

Abstract: A method for determining the pyrogenicity of a substance, comprising the step of incubating said substance in the presence of a cell mixture for at least 46 hours at 35.degree. to 39.degree. C., wherein the cell mixture comprises human lymphocytes and human monocytes with a cell ratio of lymphocytes to monocytes of at least 2:1 and a composition with respect to the total of all cells present comprising at least 15% monocytes and no more than 10% granulocytes and wherein the cells have a contact ratio of from 0.0 to 0.75.

Abstract: Diagnostic assays are provided employing a naturally occurring membrane receptor for a compound of interest and a labeled antagonist and providing for competition between the antagonist and a sample suspected of containing the compound of interest. By measuring the partition of the labeled antagonist between the receptor and the liquid aqueous assay medium, the value can be related to the amount of compound of interest in the assay medium. Specifically, a membrane from electric ray organ is used as a source of acetylcholine receptor and labeled .alpha.-bungarotoxin is used as the antagonist. The assay medium containing the sample and .alpha.-bungarotoxin is combined with the water insoluble membrane, the membrane isolated, washed, and the amount of labeled .alpha.-bungarotoxin bound to the membrane determined. By employing samples having a known amount of acetylcholine, the measured signal can be related to the amount of acetylcholine in the sample.

Abstract: An improved radioimmunoassay for the determination of cyclic nucleotides in body fluids which comprises adding a source of divalent cation prior to assay minimizes the effects of both endogenous calcium ion and EDTA used as an anticoagulant in blood plasma samples.

Abstract: A method for determination of a steroid such as dehydroepiandrosterone sulfate (DS) in a sample of a human body liquid wherein the liquid sample is transferred to a sheet of microfilter paper and dried before being treated with an aqueous solvent to obtain a mixture wherein the dried body liquid is substantially redissolved in the aqueous solution. The mixture is contacted with an aqueous solution of an agent capable of selectively binding the steroid in the presence of a radioisotopically labeled form of steriod whereby part of the labeled steroid and part of the unlabeled steroid present in the sample are bound by forming a complex with the binding agent. Bound steroids are separated from unbound steroids in the aqueous solution and the radioactivity of at least the separated binding agent-steroids-complex or the unbound steroids is performed to determine the concentration of the hormone as a function of measured radioactivity. Additionally, a means for performing the method is disclosed.

Abstract: Compounds of the formula: ##STR1## wherein R is aryl, alkyl, cycloalkyl, phenyl, cyclopentyl, cyclohexyl, a ligand containing Tc-99m in chelated form or a ligand capable of chelating Tc-99m;R.sub.1 is H or lower alkyl;X is in the ortho-, meta or para- position, and is selected from the group consisting of .sup.125 I, .sup.123 I, .sup.127 I, I, .sup.18 F, .sup.75 Br, .sup.77 Br, NH.sub.2, and ##STR2## wherein R.sub.2 is in the 2,3, or 4 position and is selected from the group consisting of H and lower alkyl, provided that when R is a ligand capable of chelating Tc-99m or containing Tc-99m in chelated form, X is not a radioisotope and may also be H or lower alkyl;Z.sup..crclbar. is an anion; or the free amine thereof; anddenotes an asymmetric carbon atom.

Abstract: An improved method for the preparation of .sup.125 I-labelled Protein A (.sup.125 I PA) of high specific and functional activity. .sup.125 I PA has been used in combination with purified rabbit IgG (immunoglobulin G) bound to a solid support to develop a competitive binding assay capable of detecting Protein A or human, rabbit and guinea pig IgG at the nanogram level. Additionally, .sup.125 I PA may be used to detect methotrexate, leucovorin and similar substances..sup.125 I PA has also been used to detect IgG anti-Forssman antibody bound to sheep erythrocytes and to line-1 and line-10 tumor cells and as an indirect assay for tumor associated antigen in the ascitic fluid of tumor-bearing guinea pigs.Additionally, an improved method of preparation of iodination of Protein A is utilized. This procedure used the Bolton-Hunter (1973) reagent of radioactive iodine in benzene which carrier is evaporated.

Abstract: An improved immunoassay for the polypeptide hormone thymosin .alpha..sub.1 is described. The assay employs an improved antibody which is elicited by an immunogen which has been prepared by coupling [Tyr.sup.1 ]-thymosin .alpha..sub.1 to an immunogenic carrier protein using a bifunctional diazonium coupling agent.

Abstract: Procedures are presented for isolating the major outer membrane protein of Chlamydia trachomatis. The isolated protein is a species specific antigen which comprises about 60% of the C. trachomatis cell outer membrane structure. The protein has a molecular weight ranging from about 38,000 to 44,000 daltons, with a mean molecular weight of about 39,500 daltons. The protein antigen is purified from C. trachomatis cells by first extracting the cell contents with a mild anionic detergent, preferably sarcosyl, to leave a residue of intact outer cell membranes. These outer cell membranes are then extracted with a strong anionic detergent, preferably sodium dodecyl sulfate, which solubilizes the 39,500 dalton antigen. The antigen is then purified by hydroxlapatite chromatography. The antigen is species specific for Chlamydia trachomatis and may be utilized in assaying Chlamydial infection in mammals.

Abstract: Vitamin-containing multicomponent compositions are assayed to determine the extent of conversion of the vitamin to one or more analogues thereof due to interaction between the vitamin and the other components of the composition, employing a radioactive labeled form of the vitamin. The assay is useful for quality control in the manufacture of multivitamin and multivitamin-mineral formulations and vitamin-supplemented foods intended for human or animal ingestion.

Abstract: Novel amides of an iodothyronine compound such as tri-iodothyronine (T3) or thyroxine (T4) with an aminoacetic acid compound such as nitrilotriacetic acid (NTA), ethylenediaminetetraacetic acid (EDTA) or diethylenetriamine pentaacetic acid (DTPA) may be labelled, e.g. radioactively labelled with I-125, to give labelled derivatives useful in assays of a free thyroid hormone in a biological fluid which also contains the thyroid hormone bound to one or more natural binders. The novel compound T4 EDTA is shown to bind much more strongly to antibodies to T4 than to the natural protein binders in the biological fluid.

Abstract: A method and device for assaying a test substance utilizing a primary absorbent substance for selectively allowing only a quantity of an analytical reagent proportional to the quantity of test substance to pass therethrough when test substance and analytical reagent are contacted with the primary absorbent. An analytical absorbent is disposed in a series of zones for sequentially absorbing the analytical reagent which passes through the primary absorbent so that detection of the last zone of absorbed analytical reagent indicates the quantity of test substance. The method comprises passing test substance and analytical reagent through the primary absorbent and then the analytical absorbent followed by detection of the last zone in which analytical reagent is absorbed. The device comprises a funnel with the primary absorbent therein for directing the test substance and analytical reagent to a narrow tube holding the analytical absorbent.

Abstract: Immunoassay and compositions therefore for detection of human vitamin K-dependent bone protein. Heterologous labeled vitamin K-dependent protein or antigenic fragment thereof is employed with antibodies to the protein in an assay for the protein in various physiological fluids for bone extracts. The assay may be used in the diagnosis of bone diseases, by itself or in conjunction with an alkaline phosphatase assay.

Abstract: A method for diagnosing mammalian breast cancer by detecting in the physiological fluid of said mammal an antigen (ACRT) having immune cross-reactivity with human reverse transcriptase, or detecting antibodies against said ACRT or detecting antibody-ACRT complexes, wherein the reverse transcriptase is substantially purified, has a molecular of about 70,000 and a sedimentation coefficient on a glycerol gradient of between 5 and 5.5 S. A process for the purification of reverse transcriptase from human milk.

Abstract: A stabilized radioimmunoassay product consisting of an antibody protein-bound to the cell wall of a selected bacterium whereby the antibody is irreversibly bound to the protein and remains specific for the antigen against which it was developed. The radioimmunoassay product is also characterized by the fact that the resultant complete product includes a phase of serum protein treatment to isolate the protein sites or other sites of nonspecific reactivity with the labelled antigen such that the non-specific binding of labelled antigen is significantly reduced. Also within the contemplation of the invention is the method of manufacturing the radioimmunoassay product which includes the initial phase of protein binding of the antibody to the selected bacterium and the subsequent serum treatment to isolate previously unutilized protein sites such that when said sites are subsequently exposed to labelled antigen it will be rejected.

Abstract: Improvement in a competitive protein binding assay for N-5-methyltetrahydrofolic acid wherein any folate standard used is N-5-methyltetrahydrofolic acid complexed with folate binder protein. The protein of the complex is destroyed prior to the addition of immobilized folate binder protein. The immobilized folate binder protein participates in competitive binding with unknown folate and labeled folate reagents.

Abstract: The invention relates to an antiserum suitable for the determination of thioridazine in blood, blood plasma and urine, the use of the antiserum and a process of determining thioridazine in blood, blood plasma or urine with the aid of this specific antiserum.

Abstract: Tumor associated antigens are disclosed in both crude and pure form which are specific to human breast cancer. The antigens are designated BCA. Antisera, radiolabeled antigens and antisera, as well as methods for the detection of circulating BCA are also disclosed. Methods for the extraction of BCA also form part of the invention. A diagnostic kit for the detection of circulating BCA, especially one suitable for use in as radioimmunoassay is also disclosed.

Abstract: Pterin derivatives are described having the formula (I) ##STR1## wherein R represents a hydroxyphenyl group, a radioiodinated hydroxyphenyl group, a tyraminocarbonyl group, a radioiodinated tyraminocarbonyl group, a proteinocarbonyl group or a carboxy group; Q represents a straight or branched chain alkylene group having 1 to 6 carbon atoms; and R.sub.6 and R.sub.7 each represents a hydrogen, an alkyl group having from 1 to 6 carbon atoms, a hydroxyalkyl group having from 1 to 6 carbon atoms; and a radioimmunoassay method is described using a radioiodinated 4-hydroxy-2-tyraminopteridine derivative or a radioiodinated 4-hydroxy-2-tyraminocarbonylalkylaminopteridine derivative as the tracer.

Abstract: A method for the quantitative determination of renin activity in blood utilizing the measurement of Angiotensin I by treating the blood with ethylenediaminetetraacetic acid (EDTA) and the plasma with phenylmethyl sulfonylfluoride (PMSF) at a preferred pH to ascertain the full range of concentration where PMSF is effective for accurate and quick determination.Also, a method for the quantitative determination of renin activity in blood utilizing the measurement of Angiotensin I by incubating the samples after antibody addition at room temperature (23.degree. to 30.degree. C.) for 1 to 2 hours and separating the free from the antibody bound species with polyethylene glycol after having treated the blood with ethylenediaminetetraacetic acid (EDTA) and the plasma with phenylmethyl sulfonylfluoride (PMSF) at a preferred pH.