Abstract: The invention comprises a method for the purification of a human lung tumor-associated antigen (hLTAA) specific to human lung tumors of diverse histological characteristics; serum levels of hLTAA correlate with lung tumor incidence, and appear to usefully discriminate between various stages of the malignancies. The invention further comprises an immunoassay predicated on purified hLTAA for the detection and quantitative determination of hLTAA in biological fluids, particularly blood serum, and diagnostic systems for clinical immunoassay procedures.

Abstract: In a method for immunochemical assay of human chorionic gonadotropin involving use of an antibody immobilized on a carrier, an antigen and an antibody to which a labeling agent has been attached, when the antibody supported on the carrier and the antibody coupled to a labeling agent are different antibodies which are not overlapping in antigen-determining site and one of said different antibodies is specifically reactive to human chorionic gonadotropin, a high reproducibility of the result of the immunochemical assay is obtained.

Abstract: A process for detecting the presence of an antigen in a specimen is described, which process comprises:(A) contacting said specimen with a substrate coated with antibodies of said antigen, incubating the contacted substrate and washing the substrate;(B) contacting the washed material of step (A) with a hapten conjugated antibody against said antigen, incubating the so-contacted material and washing the so-incubated material;(C) contacting the washed material of step (B) with a radioactive material labeled or enzyme containing anti-hapten antibody, incubating the so-contacted material and washing the same; and(D) effecting radioimmunoassay if said antibody is radioactive or enzyme labeled immunoassay if said antibody contains an enzyme moiety.Quantitative determination of the antigen in the specimen is effected by comparing the counts of the radioimmunoassay or the concentration of enzyme against a standard as by photocolormetric methods.

Abstract: Sandwich immunoassays are provided wherein an anti-analyte antibody is coupled with a detector labeled antibody, the anti-analyte antibody being substituted with a N,N,N-trimethylammoniumphenyl group and the detector labeled antibody is an antibody specific to the N,N,N-trimethylammoniumphenyl group. The invention includes novel assays, antigens and antibodies.

Abstract: Carcinoembryonic antigen contains immune determinates in common with .alpha.-acid glycoprotein. Carcinoembryonic antigen-containing compositions are purified by adsorption onto antibody to .alpha.-acid glycoprotein. The purified compositions may be employed as standards in carcinoembryonic antigen assays or in the labelled form as tracers. Intact carcinoembryonic antigen is assayed by a modified sandwich-type immunoassay. Other cancer-associated substances may be identified by searching for high molecular weight analogues of normal proteins.

Abstract: A method for detecting the presence of Mycobacteria in a fluid or tissue which comprises mixing the fluid or tissue containing a secretory product of Mycobacteria with a complex of a tracer-containing molecule and a binding macromolecule having reversible binding affinity for the tracer-containing molecule and detecting the tracer-containing molecule, wherein the tracer-containing molecule is a charcoal-adsorbable protein from Mycobacterium tuberculosis which has a molecular weight of 20,000-30,000 and which is immunochemically stable from 4.degree. C. to 250.degree. C. and has a pH range from 3.0 to 9.0. The method is particularly applicable to the detection of infectious tuberculosis in humans and determining the antibiotic sensitivity of infecting Mycobacteria.

Abstract: The present invention relates to a novel method for the quantitative determination of PEP (progestagen-associated endometrial protein) in a body fluid by radioimmunoassay. The technique is useful in monitoring the function of the human endometrium.

Abstract: A method for simultaneously isolating DNA, RNA and/or protein fractions from a crude biological mixture containing DNA, RNA and/or protein fractions is disclosed. The method comprises adding the crude biological mixture to an aqueous solution of cesium trifluoroacetate, the solution having a density from about 1.4 to about 1.6 g/ml, and centrifuging the resulting mixture under ultracentrifugation conditions.

Abstract: Method and apparatus are provided for carrying out multiple simultaneous transfers of fluid. The method and apparatus are particularly directed toward immunoassays wherein immunologically active compounds, such as antigens and haptens, are detected through their associated antibodies. The device relies on the ability to transfer fluids, such as biological samples and reagents, between a reservoir and an associated receptacle. By providing a receptacle having a port at its lower end and which is otherwise hermetically sealed, such fluid transfer can be effected by immersing the port beneath the surface of the fluid in the reservoir and manipulating the pressure on the remaining surface area outside the port. The transfer of biological fluids at positive pressure provides enhanced fluids flow characteristics, particularly reduction or elimination of the tendency of these fluids to froth or bubble.

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: Vitamin B.sub.12 in liquid samples, such as human serum or human plasma, is assayed by a competitive binding technique using intrinsic factor and certain labelled vitamin B.sub.12 derivatives. The labelled derivatives are formed from the (d)-monocarboxylic acid isomer of vitamin B.sub.12, which isomer is free from other monocarboxylic acid isomers (and derivatives thereof) of vitamin B.sub.12, by binding to the (d)-isomer, via the carboxylic group, a compound which is itself a label (e.g. an enzyme) or which comprises a label (e.g. a fluorophore), or to which a label is attached (e.g. a histidine ester to which .sup.125 I is attached). The labelled derivatives of the (d)-monocarboxylic acid of vitamin B.sub.12, free from other isomeric monocarboxylic acids and derivatives, are novel and constitute one aspect of the invention.

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 GCDFP-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: The reticulocyte content present in a specimen of red blood cells is quantitatively measured based upon the selective immunoreactivity of the reticulocyte portion of the specimen with a reticulocyte-specific antibody which is immunoreactive with proteinaceous material associated with reticulocytes but not associated with mature red blood cells. Such immunoreactive proteinaceous material may be transferrin, transferrin receptor, transcobalamin II, or transcobalamin II receptor. Various procedures are described for quantitating such selective immunoreactivity, including fluorescent and radioactive detection techniques employing direct or indirect fluorescent or radioactive labeling of the reticulocyte-specific antibody.

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: 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: 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: New reactive asymmetrical dicarboxylic acid ester compounds of the formula ##STR1## wherein R.sub.1 is an alkyl radical containing up to 3 carbon atoms or is a digoxin or digitoxin residue, R.sub.2 and R.sub.3, which may be the same or different, are alkoxy radicals containing up to 3 carbon atoms or together represent an oxygen atom, X is a cyanomethoxy, succinimide-N-oxy, N-methyl-pyridiniumoxy, 2,4-dinitrophenoxy, 2,4,5-trichlorophenoxy, pentachlorophenoxy, phenylthio, p-nitrophenoxy, p-nitrophenylthio, piperidyl-N-oxy, phthalimido-N-oxy or benztriazol-N-oxy radical and n is 2, 3, 4 or 5, are useful for the preparation of reagents for the investigation of cardiac glycosides (Digitalis glycosides).

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: 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: The method of producing clinical assays for use of monoclonal antibodies in the diagnosis of Herpes simplex virus (HSV) infections and the differentiation of Herpes Simplex virus types 1 and 2 as a diagnostic kit for differentiating HSV-1 and HSV-2 utilizing clone 1D4 against HSV-1 and clone 3E1 against HSV-2.

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: 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 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: 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: 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: A diagnostic reagent for hepatitis A antibody is prepared by adhering hepatitis A antibody to a surface by non-specific adsorption followed by specific coupling of hepatitis A antigen to the antibody. This reagent is useful in an in vitro assay for hepatitis A antibody.