Abstract: An improved method of a conventional antithrombin III activity determination method, which does not require dilution of a sample and can avoid influence of heparin cofactor II is provided. This method is characterized in that the reaction of a sample with thrombin in the presence of heparin is carried out in the presence of more than 0.2 to 0.9M of a salt, while such a reaction is carried out in the presence of 0.2M of a salt in a conventional method.

Abstract: A method for determining the sensitivity of at least one nonparaffinophilic microorganism from a specimen obtained from a patient to different antimicrobial agent, and predetermined quantities thereof. The method includes providing at least one receptacle containing an aqueous solution and adjusting the solution to mimic the in vivo clinical conditions of said patient. The method further includes inoculating the solution with the specimen and placing into the receptacle (i) a slide coated with a carbon source and (ii) a predetermined quantity of an antimicrobial agent to be tested. By observing the nonparaffinophilic microorganism growth or lack thereof on the slide, it can be determined whether the predetermined quantity of the antimicrobial agent is effective in inhibiting growth of the nonparaffinophilic microorganism on the slide. An associated apparatus is also disclosed.

Abstract: The invention is a stable reagent used in assay systems that form a colored ferric ion complex, such as Prussian Blue. Such reagents are useful for the detection or measurement of an analyte from a fluid sample. Surprisingly, it has been found that the inclusion of certain ferric ion chelating agents, such as 3-sulfobenzoic acid, will inhibit formation of the blank reaction in the reagent.

Abstract: A method of determining the presence or absence of a nonparaffinophilic microorganism in a specimen taken from a patient. The method includes providing a receptacle containing an aqueous solution and adjusting the solution to mimic the in vivo clinical conditions of the patient. The method further includes inoculating the solution with the specimen and then placing in the receptacle a slide coated with a carbon source to bait the nonparaffinophilic microorganism. The slide is then analyzed after exposure to the specimen to determine the presence or absence of the nonparaffinophilic microorganism. An associated apparatus is also disclosed.

Abstract: The present invention provides an improved reagent composition and method to perform white blood cell differential counting and subpopulation analysis using both fresh and aged blood samples with accuracy and precision. The invention is particularly applicable for the analysis of aged blood samples that have been stored at room temperature for over a day, thereby allowing accurate and useful information to be obtained from samples that are normally considered to be suboptimal. The improved reagent composition and method are particularly related to the peroxidase method of white blood cell differential determinations. One aspect of the invention includes an improved aqueous reagent composition for carrying out the peroxidase method of differential counting.

Abstract: A photo-ablation technique is used to create apertures (4) in a layer (2) of electrically insulating material and allow electrically conducting material (3) exposed through the apertures to create a microelectrode. The microelectrode can be used for assay methods and in an assay unit.

Abstract: Disclosed is a method for the quantitative determination of D-3-hydroxybutyric acid and acetoacetic acid, which comprises reacting a biological sample containing D-3-hydroxybutyric acid and acetoacetic acid, with a reagent comprising: (1) a D-3-hydroxybutyrate dehydrogenase, (2) A.sub.1 and (3) B.sub.1, the components (1), (2) and (3) participating in the following cycling reaction: ##STR1## thereby effecting the enzymatic cycling reaction, and measuring a change in the amount of A.sub.2 formed or the amount of B.sub.1 consumed. Also disclosed is an analytical reagent comprising the components (1), (2) and (3) for use in the above method. The method and the analytical reagent ensure rapidness and accuracy in the determination of D-3-hydroxybutyric acid and acetoacetic acid, even with the use of a small quantity of a biological sample, so that they are very useful in application fields, such as clinical diagnosis and food testing.

Abstract: The present invention provides a method of improving the sensitivity and accuracy of a lead assay. The method enhances the recovery of lead during isolation of the lead from interfering compounds by maintaining the lead in a sample solution and making the recovered lead available for detection by the assay. An enhancing reagent complexes with the lead isolated in the sample solution. The enhancer includes a chelator having a lead equilibrium binding constant in the range of about 4 log K to about 13 log K. A kit for performing such a lead assay is also provided.

Abstract: The present invention relates to a method for stimulating hematopoiesis in a mammal comprising administration of a therapeutically effective amount of a hemoglobin, including recombinant hemoglobin, and methods for treating cytopenias. These cytopenias include anemia, thrombocytopenia, lymphopenia, neutropenia and the like. The stimulation of hematopoiesis can occur both in vivo and ex vivo, as in the treatment of cytopenias associated with disease states, in cell culture or ex vivo expansion of bone marrow cells.

Abstract: Disclosed are a method and device for the determination of specific gravity in aqueous systems, particularly urine. The invention improves upon the known systems for detecting specific gravity by the use of a polyelectrolyte polymer and pH indicator by the addition of a crown ether ionophore which enhances the ability of the reagent system to indicate the fluid's specific gravity.

Abstract: A composite reagent, for a veterinary diagnostic test, which contains a color reagent substance to produce a color by reacting with either one or both of magnesium (Mg) ions and calcium (Ca) ions, a polyoxyethylene alkylphenyl ether, and a masking agent for interfering metal ions in a urine of an animal other than the Mg ions and the Ca ions.

Abstract: A system and method in which a photoluminescent ligand is added to a sample to be analyzed in the form of a photoluminescent probe having intrinsic analyte-induced lifetime changes. The method preferably employs phase-modulation fluorometry to measure the lifetime changes. Specific probes are disclosed for measuring various analytes, particularly ionic solutes, including H.sup.+, Ca.sup.2+ and K.sup.+.

Abstract: Calcium in a sample is brought into contact with a transglutaminase capable of being activated with calcium as an activating factor and the transglutaminase activity, which varies depending upon the calcium amount in the sample, is measured to thereby determine the calcium amount in the sample. By the method of the invention, accurate determination of calcium in various samples such as body fluids is possible without removal of proteins from them.

Abstract: A method of measuring the total ketone body in a sample comprising converting acetoacetic acid in the sample to 3-hydroxybutyric acid in advance and subsequently converting the whole 3-hydroxybutyric acid including 3-hydroxybutyric acid existing in the sample originally to acetoacetic acid to lead the reduction of nicotinamide adenine dinucleotide according to the action of 3-hydroxybutyrate dehydrogenase and a sample reagent thereof is disclosed. According to this invention an assay of the total ketone body in samples can be carried out conveniently, highly precisely and quickly.

Abstract: An agent for the detection of peroxidase or of pseudoperoxidase activity, and its preparation and its use are described. The agent contains a tetraalkylbenzidine, a peroxide and buffer substances. The agent according to the invention has, as a peroxidase substrate, the advantage over previous tetraalkylbenzidine-containing substrates that it generates higher color signals.

Abstract: A method for determining .alpha.-amylase activity which involves bringing a sample into contact with an .alpha.-glucosidase in the presence of an .alpha.-amylase substrate and optically determining a liberated label, the substrate being a maltooligosaccharide composed of at least 3 glucose units, whose reducing terminal glucose is bonded to an optically measurable label at the 1-position by .alpha.-glucoside linkage or .beta.-glucoside linkage, and whose non-reducing terminal glucose is modified by a substituent other than glucose, and the .alpha.-glucosidase being substantially capable of acting on glucose to which the label is bonded at the 1-position by .alpha.-glucoside linkage and on all maltooligosaccharides having 2 to 7 glucose units; and a reagent for determining .alpha.-amylase activity comprising the .alpha.-glucosidase and said .alpha.-amylase substrate. The present invention permits, in the determination of .alpha.

Abstract: The present invention provides for novel reagents whose fluorescence increases in the presence of particular proteases. The reagents comprise a characteristically folded peptide backbone each end of which is conjugated to a fluorophore. When the folded peptide is cleaved, as by digestion with a protease, the fluorophores provide a high intensity fluorescent signal at a visible wavelength. Because of their high fluorescence signal in the visible wavelengths, these protease indicators are particularly well suited for detection of protease activity in biological samples, in particular in frozen tissue sections. Thus this invention also provides for methods of detecting protease activity in situ in frozen sections.

Abstract: A testing system for urinalysis is provided comprising a support member which carries a developing phase, a reagent carrying means, a urine applying section, and a urine-reagent developing area. In order to prevent inaccurate test results which may result from splashing the sample onto the device, a water-repellent agent is coated onto both sides of the reagent phase and the urine-reagent developing phase, as well as onto both sides of the support member where the reagent phase and the urine-reagent developing phase are provided. The water repellent agent is solidified, and a transparent resin film is attached to the upper surfaces of the reagent phase and the urine-reagent developing phase. In another embodiment, instead of the combination of a water repellent agent and a transparent resin film attached to the upper surfaces of the reagent phase and the urine-reagent developing phase, the device is enclosed in an envelope-like or cylindrical transparent resin film or container.

Abstract: Dicitrate cyclic diester (dicitrate) is a novel compound which is found in patients who do not exhibit symptoms or predisposition to idiopathic renal calculous disease. Kits are provided for the detection of dicitrate cyclic diester.

Abstract: This invention generally relates to products and processes used to determine the presence of Enterobacteriaceae in a sample and particularly relates to a bacterial culture medium which may be used in products and processes to allow early detection and enumeration of Enterobacteriaceae in a sample. The bacterial culture medium which facilitates the early detection and enumeration of Enterobacteriaceae contains a selected amount of glucose, pH indicator and buffer which prevent diffusion of colored indicator zones associated with growing bacteria in the medium.

Abstract: A reagent system and method are described for optically measuring direct bilirubin by the reaction of a bilirubin oxidase, oxidizing agent or diazonium salt, with the direct bilirubin, wherein a tetrapyrrole compound is provided in the presence of the bilirubin oxidase, oxidizing agent or diazonium salt. It is possible to accurately measure the direct bilirubin, which is known to increase considerably in the biological fluids of patients having obstructive jaundice, etc. The reagent system and method are useful in clinical settings, etc.

Abstract: Detection of lead present in a sample, comprising the steps of: (a) adding a lead recovery agent to an assay solution containing lead from the sample; (b) adding to the assay solution a disulfide enzyme which is inhibited in the presence of lead; and (c) correlating the activity of the disulfide enzyme to the amount of lead in the sample. The lead recovery agent enhances the sensitivity and accuracy of the assay such that the assay can be readily automated for detection of lead in whole blood using commercially available automation systems.

Abstract: A composition is described which is useful in the assay of folate from a hemolysate prepared from red blood cells using non-radiolabeled assay techniques such as fluorometric, colorimetric, enzymatic or chemiluminescent assay methods. Methods to ready hemolysates for the assay of folate are also described.

Abstract: A method of enzymatic analysis utilizing a color-development signal amplification system associated with enzymatic cycling of NAD-NADH interconversion in the presence of dehydrogenase and its substrate, wherein the dehydrogenase is selected from the group consisting of alcohol dehydrogenase derived from Zymomonas and amino acid dehydrogenase derived from thermophilic microorganisms is disclosed. The use of alcohol dehydrogenase derived from Zymomonas provides an extremely higher detection sensitivity than that in the conventional method. The use of amino acid dehydrogenase derived from thermophilic microorganisms improves reliability of the method for a longer period of time than that in the conventional method.

Abstract: A reagent for assaying glucose, which comprises a first liquid reagent having a pH of 7.5 to 9.5 and containing at least either glucokinase or hexokinase, glucose 6-phosphate dehydrogenase, and adenosine 5'-triphosphate and a second liquid reagent having a pH of 3 to 5 and containing the oxidized form of nicotinamide adenine dinucleotide phosphate. The reagent can be stored as such stably for long in or out of contact with light at normal or low temperatures, so that it can be stored for long in the site of clinical examination and applied to an automatic analyzer without the necessity for dissolution prior to use.

Abstract: A stable reagent for assaying an analyte from a fluid sample which includes an enzyme, a mediator, a tetrazolium salt and an oxidizing agent selected from the group consisting of sodium chlorate, 2,5-dimethylhexane-2,5-dihydroperoxide, benzoyl peroxide, t-butyl peroxide, sodium iodate, N-ethylmaleimide, t-butylperoxyacetate, nickel acetylacetonate, stannic chloride, rhodium (III) trichloride hydrate, and t-butylperbenzoate is described. Inclusion of an oxidizing agent from the group specified above stabilizes the reagent, thereby preventing a high blank reaction because a high blank introduces error into the assay of an analyte. The reagent may be provided in solution form by adding water, or may be included in a film by adding a film-forming agent. The reagent may be utilized to perform the assay of an analyte from a fluid sample.

Abstract: An ion concentration measuring apparatus for measuring the concentration of a measuring ion in a sample solution containing the measuring ion and an interfering ion having the same ionic charge number as that of the measuring ion. This apparatus comprises a first ion-selective electrode for generating a potential in response to the measuring ion, and a second ion-selective electrode in response to the interfering ion. The first ion-selective electrode is brought about in contact with a first, second and third standard solutions, each containing known concentrations of ions. A selectivity coefficient of the ion-selective electrode is calculated on the basis of the output potential of the first ion-selective electrode. The first and second ion-selective electrodes are brought about in contact with the sample solution.

Abstract: The present invention is directed to the assay and purification of proteins, and particularly to the non-radioactive assay and purification of protein kinases, phosphatases and protease by incubating the enzyme with a substrate modified peptide to form a product modified peptide under conditions where the enzyme is active. The product modified peptide and substrate modified peptide are then separated, and the product modified peptide is measured. The present invention is also directed to kits and bioreagents for performing the assays.

Abstract: The invention relates to a polymeric optical amplifier doped with lanthanide ions, which are present in the amplifier in the form of a complex. The invention also relates to novel electrically neutral lanthanide complexes which can be applied with advantage in the above-described polymeric optical amplifiers. These complexes comprise host molecules which readily complex with the lanthanide and fully encapsulate it.

Abstract: Salicylate hydroxylase isolated from Pseudomonas bacteria can be used to determine the level of salicylate in a body fluid by reacting a sample of the fluid with the enzyme and monitoring the conversion of salicylate to catechol. A method of purifying the enzyme from crude bacterial extract using a salicylate affinity column is also disclosed.

Abstract: A D-allose specific dehydrogenase has been isolated which can be used with NAD as a cofactor in a sensitive, specific, quantitative assay for D-allose in aqueous media. A qualitative, color-based test for the presence of D-allose results when an election-accepting dye is coupled to NAD.

Abstract: A reagent composition comprising (a) one or more pH buffers, (b) one or more pH indicators, and (c) one or more surfactants as a sensitizer, is suitable for measuring ionic strength or specific gravity of aqueous solution samples such as urine rapidly and precisely.

Abstract: The present method for evaluating the extent of a lithogenesis process intensity and for determining the composition of lithogenic urate salts in urolithiasis resides in adding an aqueous protein solution to a urine sample in a ratio of 9:1, 7:1 or 5:1, respectively; applying the mixture thus-prepared as a drop onto a smooth surface for drying for at least 24 hours; determining the nature of crystallization of urate salts in the marginal zone of the urine sample, the presence of separate, singly occurring crystals, conglomerates of crystals and a complete crystallization of this marginal zone being indicative, respectively, of a weak, moderate or a highly pronounced extent of a lithogenesis process intensity; the composition of crystalline formations is determined, while, simultaneously, establishing the constitution of urate salts in the central zone of that same urine sample, followed by carrying out a comparative analysis to said two compositions to determine the composition of lithogenic urate salts.

Abstract: The method is directed to assaying for biological components in a sample comprising step (A) generating an oxidase substrate in the presence of an amphoteric surfactant and in the absence of ferrocyanide; (B) initially generating hydrogen peroxide through said oxidase reaction on said substrate of oxidase with subsequent detection of the generated hydrogen peroxide using peroxidase and a color developer capable of being oxidized in the presence of amphoteric surfactant and ferrocyanide; and (C) correlating the amount of color developed to the amount of biological components in the biological sample. Even when the biological component to be detected is present in a very small amount, the interference of bilirubin can be eliminated in assays of biological components in which peroxidase generated from an enzymatic reaction is detected using peroxidase and a color developer capable of being oxidized.

Abstract: A method of treating a patient having a panic disorder, the patient having an elevated CCK peptide plasma level, by lowering the plasma CCK peptide level of the patient. A further method provides a diagnosis of panic disorder in a patient by detecting if that patient's plasma contains elevated CCK peptide levels. A further method determines the efficacy of the drug for the treatment of panic disorder by detecting the ability of the drug to lower elevated CCK peptide levels in a model for panic disorder. Additionally, a method of dosing a patient having elevated CCK peptide levels with an antipanic disorder drug is characterized by administering the drug to a patient and monitoring the lowering of the elevated plasma CCK peptide levels of the patient.

Abstract: In a method for the determination of coagulation parameters in sample material via a reaction cascade in which a thrombin-catalyzed formation of a fibrin clot from fibrin monomers occurs and the formation of the fibrin clot is measured, an inhibitor of F XIII is added. By this means the reaction vessel can be used several times for coagulation tests.

Abstract: A method and kit for simplifying and improving the sensitivity and accuracy of a lead assay for a sample solution suspected of containing lead determines the extent of a reaction between a substrate and a disulfide enzyme in the presence of an activating reagent which contains a water-soluble tertiary phosphine reagent so as to increase the activity of the disulfide enzyme for reaction with the substrate. For a colorimetric determination of the enzyme activity a chromophore is formed upon reaction with a selected component of the sample solution in the presence of a colorimetric enhancing reagent. The colorimetric enhancing reagent contains a metal ion such as cupric ion or ferric ion which is soluble in the sample solution. The extent of the chromophore formation is then photometrically determined.

Abstract: The compound 2,3,5,6-tetrahydroxy-1,4-quinone, its derivatives and structural analogs are used as activators for intrinsic blood coagulation and as diagnostic reagents for the activated partial thromboplastin time test of blood coagulation.

Abstract: An improved mercury electrode for electrochemical analysis is formed by a small diameter thread of liquid mercury contained within an inert tube which, at one point along its length, has an short, fixed length of thin walled tubular semipermeable membrane surrounding and forming the electrodes' active surface in order to prevent or reduce fouling of the surface while allowing the mercury thread to be advanced through the membrane to expose a fresh active surface whenever desired.

Abstract: The invention provides method and kits for detecting a metallic cation in a sample of a body fluid. The preferred method and kits include the use of at least two different types of antibodies having different specificities. In the preferred method, the sample of body fluid can be contacted with an effective amount of a capture antibody specific for a naturally occurring polypeptide that can bind the metallic cation to form a first antigen-antibody complex. An effective amount of an antibody specific for an epitope on a metallic cation-naturally occurring polypeptide complex or an antibody specific for a metallic cation is added to the first antigen-antibody complex to form a second antigen-antibody complex. The amount of the metallic cation in the sample of body fluid is determined by detecting the amount of the second antigen-antibody complex.

Abstract: Aqueous solutions containing buffers and electrolytes are adjusted to levels required for calibration of both blood gas analyzers and ion selective electrolyte analyzers. A control material, composed of similar matrix, is adjusted to three levels of blood gas and electrolyte conditions. These quality control materials are used to monitor blood gas/electrolyte laboratory instrumentation.

Abstract: A simple, cost effective assay of iron is accomplished by using lactoferrin as part of a biosensor to detect iron in a sample. The lactoferrin releases protons when the iron is sequestered by the lactoferrin and the change in potential caused by the release of protons is measured by a potentiometer or pH sensing device. The sensing devices include the ion-selective or ion sensitive field effect transistors (ISFET), a potentiometric device or the pH indicator papers.

Abstract: A composition, test device and method of determining the presence or concentration of ketone bodies, and specifically D-.beta.-hydroxybutyrate, in a test sample are disclosed. The test device includes a test pad comprising a suitable carrier matrix incorporating an indicator reagent composition capable of interacting with D-.beta.-hydroxybutyrate to produce a detectable or measurable response. In addition, a new and improved indicator reagent composition, comprising a) an indicator dye that is responsive to thiols, such as a substituted isobenzothiazolone, Ellman's reagent or a derivative of Ellman's reagent; b) D-.beta.-hydroxybutyrate dehydrogenase; c) lipoamide dehydrogenase; d) D,L-lipoamide; and e) nicotinamide adenine dinucleotide, is incorporated into the carrier matrix to provide an accurate and sensitive assay of a test sample for D-.beta.-hydroxybutyrate (DHBA) in particular, and for ketone bodies in general.

Abstract: A method and multilayer analytical element for the determination of catechol and catechol generating substances such as salicylate is described. A series of enzymatic conversions involving tyrosinase is used to convert catechol to o-quinone and the latter to convert a leuco dye to a colored dye.

Abstract: The indicator compounds of the present invention are substituted or unsubstituted BAPTA-type chelators that contain a benzazolyl-coumarin substructure, and the pharmaceutically acceptable non-toxic salts and esters thereof. These compounds are useful for the detection and quantification of polycationic metal ions, particularly Ca.sup.2+.The compounds of the invention have the core structure ##STR1## or the structure ##STR2## where m=2 or 3 and X can be S, O, or C(CH.sub.3).sub.2. The above core structures are optionally substituted by substituents that alter the binding affinity of the indicator, shift the spectral properties of the indicator, or act as a reactive site for the preparation of a variety of conjugates.

Abstract: A process and a reagent for the determination of ions in fluids, wherein the influence of these ions on the activity of an enzyme is measured. The ions for example are sodium, potassium, calcium, magnesium, manganese, lithium, lead, zinc, copper, iron or other heavy metals or non-metallic ions comprising chloride, bicarbonate, protons, ammonium and substances that give rise to ammonium. The enzymes which are used may be a transferase, a hydrolase, an oxidoreductase or a lyase. An essential feature is a method to exclude interferences by ions by masking the interfering ions with a binding agent.

Abstract: A method for detecting Helicobacter pylori is disclosed which method involves contacting a sample suspected of containing Helicobacter pylori with a medium which provides for substantially selective growth of Helicobacter pylori, incubating the sample with the medium for a time sufficient for detection of Helicobacter pylori growth and detecting the growth and thereby reducing the presence of Helicobacter pylori within the sample. The methodology employs a wide range of a different culture mediums which are modified specifically for the selective growth and specific detection of Helicobacter pylori. A typical medium includes Columbia broth supplemented with urea and a pH indicator. The methodology provides for a relatively high degree of sensitivity (i.e., small numbers of bacteria present within a sample are detected) as well high selectivity (i.e., the method provides for a low percentage of false positives).

Abstract: The present invention provides a new device for use in measuring lead levels in biological and environmental samples. Using square wave coulometry and colloidal gold particles impregnated on carbon electrodes, the present invention provides a rapid, reliable, portable and inexpensive means of detecting low lead levels. The colloidal gold modified electrodes have microelectrode array characteristics and produce significantly higher stripping detection signals for lead than are produced at bulk gold electrode surfaces. The method is effective in determining levels of lead down to at least 5 .mu.g/dL in blood samples as small as 10 .mu.L.

Abstract: The indicator compounds of the present invention are substituted or unsubstituted 5'-nitro-BAPTA chelators that contain a benzazolyl-coumarin substructure, and the pharmaceutically acceptable non-toxic salts and esters thereof. These compounds are useful for the detection and quantification of polycationic metal ions, particularly Zn.sup.2+, Pb.sup.2+, Ba.sup.2+, Cd.sup.2+, Hg.sup.2+ and La.sup.3+.The compounds of the invention have the structure: ##STR1## where m=2 or 3 and X can be S, O, or C(CH.sub.3).sub.2 ; optionally substituted by substituents that alter the binding affinity of the indicator, shift the spectral properties of the indicator, or act as a reactive site for the preparation of a variety of conjugates.