Abstract: A device for collecting, testing and storing fluids includes a container and a removable cap. Body fluids, such as urine, are collected in the container. The cap defines a test strip holder that receives one or more drug test strips and an adulteration strip. An opening defined through a bottom of the cap provides fluid communication between the container and the cap. When tilted, fluid from the container enters the cap through the hole. A variety of plugs may be employed to block the opening and thereby prevent fluid communication between the container and the cap after fluid has entered the cap. The remaining uncontaminated and untested body fluid is stored in the container and thus made available for further confirmation testing. Associated methods for collecting, testing and storing fluids with a single device are also provided. A method of manufacturing the foregoing test device is also provided.

Abstract: A device for collecting, testing and storing fluids includes a container and a removable cap. Body fluids, such as urine, are collected in the container. The cap defines a test strip holder that receives one or more drug test strips and an adulteration strip. An opening defined through a bottom of the cap provides fluid communication between the container and the cap. When tilted, fluid from the container enters the cap through the hole. A variety of plugs may be employed to block the opening and thereby prevent fluid communication between the container and the cap after fluid has entered the cap. The remaining uncontaminated and untested body fluid is stored in the container and thus made available for further confirmation testing. Associated methods for collecting, testing and storing fluids with a single device are also provided. A method of manufacturing the foregoing test device is also provided.

Abstract: A method and device for collection of a stool specimen. Formation of the device occurs in situ by providing a liquid absorbent polymer to water contained in a toilet bowl. The hydrated polymer forms a matrix that is capable of supported a stool specimen deposited thereon. The method and device provides a simple, economical, and less distasteful means for collecting, sampling and evaluating a stool specimen for diagnosis and/or therapy.

Abstract: A device and method for performing a rapid immunoassay for a biological analyte containing a positive control analyte which is concurrently tested using the same device and immunochemical reaction as the biological analyte. The positive control analyte is non-crossreactive with the biological analyte to be detected and may be an immunogen or a hapten. The device and method permit operators of the test device, particularly non-laboratory professionals, to determine that an assay is performed correctly and that the device is functioning properly, thereby allowing the operator to have confidence in the accuracy of either a positive or negative result. This is particularly important when a positive result is indicated by the absence of color at a test site, which is counterintuitive with many operators and which frequently occurs with a competitive immunoassay.

Abstract: A device and method to detect oxidant adulterants added to a sample to prevent detection of tetrahydrocannabinol and/or tetrahydrocannabinol metabolites. The device and method detect popularly available adulterants such as chromate and nitrite through their reaction with a chromogenic substrate for a peroxidase enzyme. The substrate may be applied to a pad. A change in color in the presence of the oxidant may be detected directly or indirectly. The device and method may be used to detect the presence of any oxidant adulterant and is not specific for only one or a few adulterants added to a urine sample submitted for drug testing.

Abstract: A device and method to detect oxidant adulterants added to a sample to prevent detection of tetrahydrocannabinol and/or tetrahydrocannabinol metabolites. The device and method detect popularly available adulterants such as chromate and nitrite through their reaction with a chromogenic substrate for a peroxidase enzyme. The substrate may be applied to a pad. A change in color in the presence of the oxidant may be detected directly or indirectly. The device and method may be used to detect the presence of any oxidant adulterant and is not specific for only one or a few adulterants added to a urine sample submitted for drug testing.

Abstract: This invention features methods and kits for identifying human urine samples for forensic purposes.

Abstract: A method for the direct determination of the toxicity of a solid material by direct contact between the solid sample and a luminescent microorganism, consisting of the steps of forming a suspension of a luminescent microorganism in a 0.5% to 6% solution of NaCl or 20% solution of sucrose in distilled water diluent and contacting a sample of the solid to be tested directly with the suspension of luminescent microorganisms. A control including the microorganism in the diluent is also prepared. The combination of microorganism suspension and solid sample is incubated for a sufficient time to allow for the toxicity of the sample to affect the metabolism of the living organism. During or subsequent to the incubation period the combined organism and sample are subjected to a separation step to separate a major portion of the particulate solid from the suspension of microorganisms.

Abstract: A method for obtaining an actual linear standard curve in a sandwich type of immunoassay where a first antibody bound to an insoluble support and a second unbound labelled antibody complex with the antigen contained in a test sample to form an insoluble antibody:antigen:labelled antibody complex which is then detected. Unbound unlabelled first antibody and/or unbound unlabelled second antibody are added to the reaction mixture to divert excess antigen away from the desired end-product complex, thus rendering the antigen of interest the rate-limiting factor in the overall immunoreaction. This results in a pseudo first-order reaction which produces an actual linear standard curve.

Abstract: An immunoassay for assaying an antigenic substance (Ag) in a fluid. The immunoassay is the type which comprises contacting the fluid with at least one first entity selected from a group consisting of an antibody (Ab) to the Ag, a soluble, labeled antibody (L-Ab.sub.a) to the Ag, and an antibody (Ab.sub.b) to the Ag bound to a solid support (SC). The immunoassay is characterized in that the fluid is contacted with at least one additional entity selected from a group consisting of at least one different type of soluble, labeled antibody (L-Ab.sub.c) to the Ag, at least one different type of antibody (Ab.sub.d) bound to a solid carrier (SC.sub.1), and at least one different type of antibody (Ab.sub.e) to the Ag. The SC.sub.1 is selected from a group consisting of SC, at least one different solid carrier (SC.sub.2), and mixtures thereof (SC and SC.sub.2). Each type of L-Ab.sub.c, Ab.sub.d -SC.sub.1, and Ab.sub.e has a lower average affinity constant (K) for Ag than each respective K of L-Ab.sub.a, Ab.sub.

Abstract: A direct particle agglutination immunoassay for assaying an antigenic substance (Ag) in a fluid. The immunoassay is the type which comprises:(a) contacting the fluid with an antibody (Ab) coated particle (P) to agglutinate the Ab coated particles; and(b) detecting the presence of agglutination.The immunoassay is characterized in that the fluid is contacted with at least one additional entity selected from a group consisting of at least one different type of antibody (Ab.sub.a) coated particle (P.sub.1) and at least one different type of antibody (Ab.sub.b). The P.sub.1 is selected from a group consisting of P, at least one different particle (P.sub.2), and mixtures thereof (P and P.sub.2). Each type of Ab.sub.a -P.sub.1 and Ab.sub.b has a lower average affinity constant (K) for Ag than the K of Ab-P and the additional entity is present in an amount sufficient to avoid a high antigen false negative effect.Also, a reagent of the type comprising Ab-P.

Abstract: A kinetic assay is provided for determining the acid phosphatase in an aqueous solution by measuring the amount of of reduced coenzyme produced. The assay is based on the following coupled reactions:I. organic phosphate .sup.acid phosphatase PO.sub.4.sup.-3 +organic alcoholII. maltose+PO.sub.4.sup.-3 maltose phosphorylase glucose+ .beta.-D-glucose-1-phosphate;III. .beta.-D-glucose-1-phosphate .beta.-D-phosphoglucomutase glucose-6-phosphate;IV. glucose-6-phosphate+NAD glucose-6-phosphate dehydrogenase NADH+6-phosphogluconate.

Abstract: A kinetic assay is provided for determining the inorganic phosphate content in an aqueous solution by measuring the amount of reduced coenzyme produced. The assay is based on the following coupled reactions:I. maltose+PO.sub.4.sup.-3 maltose phosphorylase glucose+.beta.-D-glucose-1-phosphate;Ii. .beta.-d-glucose-1-phosphate .beta.-D-phosphoglucomutase glucose-6-phosphate;Iii. glucose-6-phosphate+NAD glucose-6-phosphate dehydrogenase NADH+6-phosphogluconate.

Abstract: The range of linearity of the kinetic method for the determination of glucose concentrations using a reagent of the type comprising a buffer, a pyridine coenzyme, and glucose dehydrogenase, is significantly increased when the buffer employed in the reagent has a pH of from about 7.9 to about 9.0.

Abstract: A reagent system for beta-amylase assay comprising:A polysaccharide having glucose molecules primarily connected through alpha 1,4 linkagesPhosphate ionsMaltose phosphorylaseA co-enzyme selected from a group consisting of beta-nicotinamide-adenine dinucleotide, beta-nicotinamide-adenine dinucleotide phosphate, and mixture thereofGlucose-6-phosphate dehydrogenaseBeta-D-phosphoglucomutaseMutarotase.

Abstract: A kinetic assay is provided for measuring alpha-amylase content in aqueous solutions. The assay is based on the following reactions:alpha-1,4 linked glucan .sup.alpha-amylase alpha-maltosealpha-maltose + PO.sub.4 .sup.-.sup.-.sup.- .sup.MP Glucose + beta-D-G-1-Pbeta-D-G-1-P .sup.beta-PGM G-6-PG-6-P + NAD .sup.G6PDH 6-P-G + NADHthe concentration of alpha-amylase is determined by measuring the rate of increase in absorbance associated with the production of NADH which is a measure of the activity of alpha-amylase.A novel reagent system is used with the assay and comprises:A polysaccharide having glucose molecules primarily connected through alpha 1,4 linkageMaltose phosphorylase (MP)Phosphate ions (PO.sub.4 .sup.-.sup.-.sup.