Abstract: Aqueous solutions of steroid compounds which have biological activity and have a tendency to oxidative degradation at temperatures between 2.degree. and 8.degree. C. on storage in excess of several months are stabilized by the addition of cyclodextrin.

Abstract: The present invention relates to the field of cancer immunoassay. Specifically, a new immunoassay method for prostate specific antigen (PSA) is presented. Also presented is a complex which resembles a complex of PSA and .alpha.-antichymotrypsin (ACT) that can be used as a calibrator or control in an immunoassay for PSA. Further presented is a method for fractionating polyclonal antibodies, to PSA, into those which bind epitopes that are masked by the binding of PSA to ACT and those which do not bind such epitopes.

Abstract: This invention presents novel assay devices employing capture reagents, involving a specific binding member attached to a charged substance, and porous material containing a capture or reaction zone that is oppositely charged with respect to the charged substance included in the capture reagent. In one embodiment, a test sample suspected of containing the analyte of interest is contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged capture or reaction zone to attract, attach, and immobilize the capture reagent/analyte complex. With an appropriate indicator reagent, both sandwich and competitive assays can be performed.

Abstract: A panel of probes detects and distinguishes between sets of human p53 gene or protein mutations that frequently occur or are selected for in pre-cancer and cancer cells Each set of mutations gives rise to a phenotype that is different from that of wild-type p53 and of at least one other set of p53 mutations.

Abstract: The present invention relates to the field of cancer immunoassay. Specifically, a new immunoassay method for prostate specific antigen (PSA) is presented. Also presented is a complex which resembles a complex of PSA and .alpha.-antichymotrypsin (ACT) that can be used as a calibrator or control in an immunoassay for PSA. Further presented is a method for fractionating polyclonal antibodies, to PSA, into those which bind epitopes that are masked by the binding of PSA to ACT and those which do not bind such epitopes.

Abstract: The present invention discloses novel compounds useful as alkaline phosphatase inhibitors and therapeutic agents. Preferably, the novel compounds are useful as selective inhibitors of human alkaline phosphatases as opposed to Escherichia coli alkaline phosphatases. The novel compounds can also be used as cancer therapeutic agents, anti-depressive agents, anti-anergic agents, and antihelminthic agents. The novel compounds have the following general formula: ##STR1## wherein R' is an aryl, aryl ether, aryl thioether, aromatic heterocyclic, aromatic heterocyclic thioether, or aromatic heterocyclic ether group. More preferably, R' is a phenyl or a pyridine. Most preferably, R' is of the following formula: ##STR2## 2-thiopyridine, or ##STR3## 2-oxypyridine. R.sub.1, R.sub.2, R.sub.3, R.sub.4, R.sub.1 ', R.sub.2 ', R.sub.3 ', R.sub.4 ', and R.sub.5 ' can be the same or different, and at least one of which is selected from the group consisting of: H, C.sub.1 -C.sub.6 alkyl, halo C.sub.1 -C.sub.6 alkyl, phenyl, C.

Abstract: A stabilized liquid enzyme composition is prepared containing at least one enzyme substrate or analog thereof and/or at least one enzyme product or analog thereof combined with the enzyme in a liquid medium containing. The liquid medium may be human, animal or artificial serum. The composition may also contain an activator chosen from a sulfhydryl compound and a divalent metal ion. In a preferred embodiment, the enzyme is isolated creatine kinase MB(CKMB), the substrate may be adenosine triphosphate, its oxidized or analog form, creatine or its analog, and the product may be adenosine diphosphate, its oxidized or analog form or phosphocreatine or its analog. The activator is preferably N-acetyl-cysteine or .beta.-mercaptoethanol. In a preferred embodiment, CKMB is stabilized with a combination of adenosine triphosphate and creatine. A preferred serum is heat-inactivated alkaline-shocked human serum.

Abstract: An improved, "gap filling" embodiment of the Ligase Chain Reaction (LCR) is described. Gap filling LCR is LCR wherein at least one of the probes is recessed so that a gap is formed between the adjacent probes when they are hybridized to target. The gap is filled using polymerase and deoxyribonucleotide triphosphates before ligation of the probes together. There are single and double gap versions, depending on whether one or two probes are recessed and require filling before ligation. The improvement resides in selecting and using target sequences such that only a single type, or two types, of deoxyribonucleotide triphosphate(s) are required to fill double gaps each being 1-10 bases in length, preferably 1-3 bases. Probes having specific sequences are claimed for a number of pathogens.

Abstract: The present invention includes adhesive solutions, devices and a method for the preparation of histological, cytological, immunological and proteinaceous samples for evaluation. The devices involve at least one sample deposition area formed from an adhesive composition, containing from about 0.003% to about 1.0% 1,5-dimethyl-1,5-diazaundecamethylene polymethobromide in a suitable solvent, wherein the adhesive composition is dried upon a solid support material such as a glass microscope slide or the like.

Abstract: The present invention is directed to a fluorescence polarization assay for phencyclidine and phencyclidine derivatives, to the various components needed for preparing and carrying out such an assay, and to methods of making these components. Specifically, tracers, immunogens and antibodies are disclosed, as well as methods for making them, and a reagent kit containing them. The tracers and the immunogens are made from substituted phencyclidine compounds. A fluorescein moiety is included in the tracer, while a poly(amino acid) forms a part of the immunogen. The assay is conducted by measuring the degree of polarization retention of plane polarized light that has been passed through a sample containing antiserum and tracer.

Abstract: A stabilized anoxic diagnostic reagent solution comprising an oxygen labile reagent, glucose oxidase, glucose, a hydrogen donor, sterile membrane fragments derived from bacteria having membranes containing an oxygen transfer system, and a reagent binding agent. The stabilized reagent has at least six months storage stability at 2.degree.-8.degree. C. and open vial stability of at least three weeks.

Abstract: A data interface which is capable of receiving test information from a variety of biological fluid testing instruments employs first and second processes. The first process determines the type of data which is provided by analyzing the format of the test information using a master rules file. Once the type of the source is identified, the first process passes the data and a set of rules to use to parse the data to the second process. The second process extracts the test data from the information provided by the testing instrument using the set of rules identified by the first process. Furthermore, if the test information is received in pieces the present invention can marry the pieces to provide a complete data set to be stored in the database.

Abstract: A coupling agent useful in conducting immunoassays, particularly assays for B12, is disclosed. The coupling agent has the formula ##STR1## Z and Z' can be the same or different and each is ##STR2## k, m and n are integers from 1 to 10, X is an alkylene group, a cycloalkylene group, an alkylcycloalkylene group, a bivalent aromatic group, or an aminoalkylene group, R and R' can be the same or different, and each is a substituted or unsubstituted aminoalkylene group having from 1 to 10 carbon atoms or a cycloalkylene or alkylcycloalkylene group having from 5 to 20 carbon atoms. Z and Z' are the same except that they can be the same or different when both are ##STR3## A method for purifying an aqueous intrinsic factor solution which contains R-protein is disclosed.

Abstract: The present invention encompasses an improved immunoassay method which involves the simultaneous transfer of multiple antigens onto a single solid support. The antigens which may be utilized by this method may be either naturally or recombinantly produced and may be purified on a variety of electrophoresis gels. This method is particularly useful to provide an extremely sensitive multiple component assay using essentially pure antigenic polypeptides capable of detecting the presence or antibodies to HIV-1 or HIV-2 viruses in infected patients.

Abstract: A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immuno assays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge.

Abstract: A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immuno assays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge.

Abstract: The instant invention is a method of coupling compounds comprising the steps of:a) forming a maleimide derivative by reacting a maleimide containing compound having the formula: ##STR1## with an amine functional compound capable of displacing the N-hydroxysuccinimide group; andb) reacting the derivitized maleimide of step (a) with a second amine functional compound.

Abstract: A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immunoassays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge.

Abstract: An indicator reagent, assay method and test kit for determining the presence or amount of an analyte in a test sample, in which the indicator reagent is formed by attaching an organic polymer latex particle, preferably a colored particle, to a specific binding member. The specific binding member can be adsorbed onto or covalently bound to the organic polymer latex particles. The organic polymer latex particles are readily detected by direct visual observation or can be detected and/or measured by appropriate instrumentation.

Abstract: A fluorescence polarization immunoassay (FPIA) for detecting the presence of one or more amphetamine-class analytes in a test sample is provided. The immunoassay uses competition between the analyte and a fluorescently labeled tracer for the binding site on an antibody specific for phenethylamine derivatives. The concentration of amphetamine-class analyte in the sample determines the amount of tracer that binds to the antibody. The amount of tracer/antibody complex formed can be quantitatively measured and is inversely proportional to the quantity of analyte in the test sample. The invention relates to tracers, to immunogens used to elicit antibodies for use as assay reagents, and to assay kits incorporating these tracers and assay reagents.