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: 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: 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: 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: A radioreceptor assay for benzodiazepines in saliva which comprises measuring the diminution of attachment of a known quantity of radio labeled benzodiazepine to a receptor carrier in the presence of an unknown quantity of unlabeled benzodiazepine in a known amount of human saliva. Benzodiazepines are selected from the following oft-utilized drugs which are also representative types of benzodiazepine; namely, diazepam (Valium), chlordiazepoxide (Librium), nitrazepam (Benzalin), oxazepam (Serax), flurazepam (Dalmane), and clorazepate.Competitive receptors suitable for the present benzodiazepine radioreceptor assay are from fresh rat frontal cortex. Utilizable receptors are whole brain cortex, human cortex, and striatum.

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: 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 for the detection of malignant leukocytic cells which comprises:contacting a fluid containing malignant leukocytic cells with a merocyanine dye of the formula: ##STR1## wherein n=1-5; X=0 or S; R.sub.1 and R.sub.2 are the same or different C.sub.2 -C.sub.5 alkyl groups:wherein said dye is incorporated into said cells; separating the cells from the incubation mixture; and detecting said dyed cells. Fluorescence or radioactivity detection methods are preferred detecting means.

Abstract: A serum sample is heated at an alkaline pH to release folate and vitamin B.sub.12 from endogenous binders. A simultaneous radioassay for folate and vitamin B.sub.12 is effected by contacting the sample with binder for folate, binder for vitamin B.sub.12, folate labeled with one radioactive isotope and vitamin B.sub.12 labeled with another radioactive isotope, followed by separation of bound and free portions, and determination of the radioactivity of at least one of the portions. The amounts of folate and vitamin B.sub.12 present in the sample may be determined from standard curves.

Abstract: A new radioenzymatic assay for catecholamines utilizing the catechol-O-methyl transferase transfer of a methyl group from a labeled methyl donor to the catecholamines followed by isolation of the O-methylated(H)catecholamine and the subsequent measurement of radioactivity.

Abstract: Competitive protein binding radioassay for sera (or cell) vitamin B.sub.12 and/or serum folate (target components, or analytes) or other target components in liquid ambient utilizing a highly alkaline (pH 12-14) environment and reducing agent for denaturing separating the target component(s) from serum without boiling, consistent with other requirements of such assays, then reducing pH to an 8-10 range for effecting the competitive protein binding after which protein bound and unbound groups of radioactively tagged replicates of the target component(s) can be separated and detected to determine content of the target component(s) in the original serum (or cell), i.e. original endogenous analyte(s).

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: An immunoassay for the measurement of free thyroid hormone, i.e., thyroxine or 3,5,3'-triiodothyronine, in a liquid sample in which the thyroid hormone is present in both free and combined states, which immunoassay comprises the steps of:A. combining the sample with a labeled thyroid hormone-horseradish peroxidase conjugate which does not significantly interact with the thyroxine-binding globulin and thyroxine-binding prealbumin originally present in the sample and immobilized antibody which is specific for the thyroid hormone;B. incubating the resulting mixture;C. separating a solid phase from the liquid phase; andD. measuring the amount of labeled thyroid hormone-horseradish peroxidase conjugate present in either phase by means of the activity of the label.

Abstract: The method comprises covalently binding an immuno-reactive to a selected macromolecular carrier and then contacting the resulting hapten-carrier conjugate at a selected concentration in a liquid phase with a selected solid phase until a desired amount of the hapten-carrier conjugate is adsorbed to the surface of the solid phase. Unbound hapten-carrier conjugate is then separated from the solid phase, and the solid phase containing the bound hapten-carrier conjugate is recovered for use in quantitative immunoassays and the like. The solid phase can be, for example, surfaces of a test tube or microtiter well or the like. The method is simple and inexpensive and permits hapten assays of improved sensitivity.

Abstract: A method for diagnosis of rheumatoid arthritis and related diseases comprises determination of polyclonal lymphocyte activation in B-cells cultured in the presence of patient serum. A diagnostic kit is also provided.

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: 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: 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: An indirect, non-destructive, quantitative assay for the presence of antigens or antibodies in a biological fluid. The assay is based on the interfunctional behavior of a known biological material with the material whose presence is quantitatively sought. In the assay, the known biological material by a correlative action links two discreet interfunctional particles together within a zone of activation with one of the particles emitting light-pulses upon bombardment of electrons from the other particle within the zone of activation. Depending upon which presence is sought to be measured, i.e.; antigen or antibody, the detectable light-pulses give one measurement which gives the ultimate quantitative measurement of the presence of either an antibody or antigen in the biological fluid after their initial interfunctional behavior one to the other. The interfunctional behavior itself is conventional and known in the art.

Abstract: A hapten is obtained by replacing the 3-hydroxy group of equilin with HO--CO--A--O-- wherein A is an alkylene of one to six carbon atoms. The hapten is conjugated with an immunological carrier to provide an immunogen, which in turn produces a specific antiserum to equilin. The antiserum is used in a radioimmunoassay for equilin.

Abstract: A hapten is obtained by replacing the 3-hydroxy group of 17 .alpha.-dihydroequilin with HO--CO--A--O-- wherein A is an alkylene of one to six carbon atoms. The hapten is conjugated with an immunological carrier to provide an immunogen, which in turn produces a specific antiserum to 17 .alpha.-dihydroequilin. The antiserum is used in a radioimmunoassay for 17 .alpha.-dihydroequilin.