Abstract: A synthetic urine solution and method of its manufacture are disclosed. The solution includes water having a pH between 3 and 10. The solution further includes creatinine and means for removing bacteria from the solution so as to control or eliminate sepsis of the urine solution, preferably through the use of biocide. The solution exhibits a specific gravity of from 1.005 g/cm3 to 1.025 g/cm3. Additional compounds may also be included to further enhance the aesthetics or apparent authenticity of the synthetic urine produced according to this invention.

Abstract: The invention provides methods for stabilizing 5-azacytidine against hydrolysis in plasma. By extracting the 5-azacytidine into acetonitrile and zinc sulfate, the 5-azacytidine can be stored for at least about 3 hours at about room temperature, and for at least about 4 days at about ?70° C. If the acetonitrile is removed and evaporated to dryness, the 5-azacytidine in the resulting residue is stable for at least about 14 months at about ?70° C. The invention also provides methods for determining the 5-azacytidine in acetonitrile, or in the acetonitrile residue, using, for example, high-performance liquid chromatography. The methods of the invention permit a significant time interval between the initial processing of the whole blood sample and the time of 5-azacytidine determination.

Abstract: Methods, devices and kits for facilitating medical diagnostic assays and reducing the time required for taking of such assays. The methods comprise initiating a reaction, obtaining at least three measurements, at three different time points, of a value or level of an observable associated with the reaction, and estimating an end point value for the observable from the measurements.

Abstract: A method for assessing aspirin resistance and relative risk of a cardiovascular event in a patient taking aspirin is provided. The concentration of 11-dehydro-thromboxane B2 in a urine sample is measured and compared to a set of standardized quartile concentrations. A concentration of urinary 11-dehydro-thromboxane B2 that falls within the second, third, or fourth quartile is indicative of aspirin resistance and an elevated risk of a recurrent cardiovascular event.

Abstract: A method of detecting creatinine in body fluids using an indicator which produces a fluorescent response when oxidized in the presence of a copperII/creatinine complex. A preferred indicator is 4-(1-methylhydrazino)-7-nitro benzooxadiazole (MNBDH).

Abstract: Nitroaromatic compounds and immunogenic conjugates comprising a novel nitroaromatic compound and a carrier protein are disclosed. The invention further presents monoclonal antibodies highly specific for the claimed nitroaromatic compounds, the compounds' protein conjugates, the compounds' reductive byproducts, and adducts formed between the compounds and mammalian hypoxic cell tissue proteins. The invention is further directed to methods for detecting tissue hypoxia using immunohistological techniques, non-invasive nuclear medicinal methods, or nuclear magnetic resonance. Diagnostic kits useful in practicing the methods of claimed invention are also provided.

Abstract: Zaleplon can be separated from a regioisomer impurity by crystallization from selected solvents or by adding an anti-solvent to a solution of zaleplon and the regioisomer. Zaleplon crystalline Forms II, III, IV, and V are useful for the treatment of insomnia. These crystalline Forms are described along with processes for making them v crystallization from selected solvents.

Abstract: The synthesis of novel diketopiperazines, their use in inhibiting cellular events such as those involving NFK-&agr;, NFK-&bgr; and in the treatment of inflammation events, a combinatorial library of diverse diketopiperazines and process for their synthesis as a library and as individual compounds. In particular novel diketopiperazines are disclosed including their synthesis and use in cellular events such as activation of the transcription factor, nuclear factor, TNF-&agr;, TNF-&bgr; and also apoptosis.

Abstract: The present invention is a method for drug level detection by using a simplified and effective deproteinizing step from body fluids, such as plasma, blood, urine, saliva, tear fluid, followed by drug extraction and measurement using an accurate technique, such as a colorimetric assay or a High-Performance Liquid Chromatography method. In a particular embodiment, the invention is directed to a method to quantify rifampicin in order to monitor its levels in body fluids and also to a Kit for rifampicin concentration measurement.

Abstract: Apparatus and method for determining at least one parameter, e.g., concentration, of at least one analyte, e.g., urea, of a biological sample, e.g., urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample.

Abstract: Disclosed are therapeutic compounds having the formula: (R)j—(CORE MOIETY), including resolved enantiomers, diastereomers, hydrates, salts, solvates or mixtures thereof where j is an integer from one to three. The core moiety is a bicyclic ring structure having at least one heterocyclic ring that contains five to six ring atoms and up to two nitrogen heteroatoms. R is selected from the group consisting of hydrogen, halogen, hydroxyl, amino, substituted or unsubstituted benzyl, C1-6 alkyl or C1-6 alkenyl, and at least one R has the formula I: n is an integer from 1 to 20, at least one of X or Y is —OH. Another of X or Y, which is not —OH, is hydrogen, CH3—, CH3—CH2—, CH3—(CH2)2—or (CH3)2—CH2—, and each W1, W2, and W3 is independently hydrogen, CH3—, CH3—CH2—, CH3—(CH2)2— or (CH3)2—CH2—.

Abstract: Long wavelength, narrow emission bandwidth fluorecein dyes are provided for detecting specially overlapping target substances. The dyes comprise 4,7-dichlorofluoresceins, and particularly 2′,4′,5′,7′-tetrachloro-4,7-dichloro-5-(and 6-) carboxyfluoresceins. Methods and kits for using the dyes in DNA analysis are provided.

Abstract: The invention disclosed herein relates to the preparation of pharmaceutical grades of histamine dihydrochloride using a two step non-enzymatic synthetic method. The invention disclosed herein describes the synthesis of histamine dihydrochloride by the non-enzymatic decarboxylation of histidine and the step-wise conversion of the decarboxylated product to the dihydrochloride salt form. The invention disclosed herein considers a final product of histamine dihydrochloride containing less than each of the following: 0.8% L-histidine HCl monohydrate, 0.1% individual chromatographic impurities, and 2% total impurities, to be acceptable for pharmaceutical use.

Abstract: Techniques and devices for detecting and analyzing controlled substances and the like are discussed including highly reactive sensor molecules which are coated on a spectroscopic sample surface (4) and which may chemically react with a given analyte to form a covalently bonded adduct with spectral characteristics unique to the new adduct. The techniques provide the basis of a detection system with high sensitivity and high specificity in which the surface can even be washed to remove interfering or nonreactive compounds. The sensor molecules which comprise the coating (8) may have three major components: a central molecular scaffold (“CMS”), a “tether” terminated by a surface attachment group “SAG,” and a reactive functional group “RFG” which may be highly reactive towards certain classes of molecules.

Abstract: Methods and apparatus are disclosed which are useful for detecting the presence of various pesticides, including aryl pyrazoles such as fipronil. Pesticide residues are extracted from a variety of samples, including soil and/or water samples using techniques well known to those of skill in the art. The samples are then concentrated, and transferred to an solid phase extraction cartridge. The SPE cartridge includes activated charcoal, silica gel, magnesium-silica gel and an amino-functional silica sorbent, or suitable equivalents thereof. After cleanup, the eluate containing the analyte of interest can be concentrated to a standard sample size and the amount of pesticide residues quantitated. In a preferred embodiment, the column chromatography materials are assembled in a solid phase extraction cartridge with frits between the chromatography materials. This facilitates the use of the cartridge in standard automated analytical equipment, for example, robotic equipment.

Abstract: A test strip for simultaneously measuring a plurality of analytes in blood or other fluids comprising a plurality of reagent pads containing reagents specific to particular analytes located on a support. Each reagent pad is covered and in close contact with a sample distributing layer and an optional blood filtering layer. Color produced by analytes in the sample is viewed through apertures in the support. The colors of the pads are read simultaneously with an instrument such as a reflectance meter containing individual LED's as light sources for each reagent pad. The intensity of the color of the individual pad can be used to detect semi-quantitative or quantitative concentration of analytes in a sample on site, allowing for quick communication of results to a remote site by electronic means.

Abstract: A device for detecting and indicating the caffeine concentration of a beverage includes a disposable test sheet having a reagent section and a color chart. The reagent section is impregnated with a reagent which, when reacted with caffeine, produces a characteristic chromogenic and color change. These changes vary according to the caffeine concentration of a tested beverage sample. The color chart includes a plurality of color gradations corresponding to ranges of caffeine concentrations and includes numerical indicia corresponding to respective color gradations. The color chart further includes indicia indicative of representative beverages corresponding to respective color gradations and numerical ranges. The color chart may be arranged concentrically about the reagent section or in tabular list form. The test sheet includes a polymeric layer to prevent a beverage sample from soaking through the reagent section.

Abstract: Disclosed is a method for determining the concentration of an analyte in a sample of body fluid. The method involves contacting the body fluid sample with a test strip containing mobile, labeled specific binding partner for the analyte, through which strip the test fluid, analyte and any complex formed by interaction of the analyte and labeled specific binding partner therefore can flow by capillarity. The strip contains at least one zone for capture of the labeled specific binding partner and at least one separate zone for retention of the analyte/labeled specific binding partner complex. By determining the magnitude of the signal from the detectable label in the capture zone(s) and retention zone(s) and determining a final response signal by correlating signals using an algorithm and number of zones chosen in a manner that provides a final response signal best suited for the particular assay, the concentration of the analyte can be determined with greater precision.

Abstract: The present invention provides structure-based combinatorial libraries of compounds containing the functional group minima of picornaviruses including poliovirus and rhinovirus. The libraries can be used to screen for therapeutical antiviral compounds, e.g., anti-picornaviral capsid-binding compounds.

Abstract: A method of testing the purity or stability to degradation of a sample of lamotrigine or a pharmaceutical dosage form comprising lamotrigine comprises assaying the said sample for the presence of a compound selected from 3-amino-6-(2,3-dichlorophenyl)-1,2,4-triazine-5-(4H)-one (compound A) and N-[5-amino-6-(2,3-dichlorophenyl)-1,2,4-triazine-3-yl]-2,3-dichlorobenzamide (compound B). A process for producing compound B, which is novel, is also disclosed.

Abstract: A device for analyzing simultaneously multiple analytes in a fluid of unknown composition. The device includes a plurality of sensors, a light source for providing light to shine on the sensors, light detectors, and a processor. The sensors are exposed to a sample of the fluid of unknown composition. The plurality of sensors includes groups of sensors, each group targeting a specific analyte and including one or more sensors that contain an analyte-specific chemical that interacts more specifically with one analyte than with some other analytes to be analyzed. Each sensor in each group has a different chemical interacting with the analyte to target it. The light source shines light on the sensors of the plurality of sensors to cause light interaction with the sensors. The differences in the sensors lead to differences in the light interaction. The light detectors detects the light interaction by the sensors.

Abstract: A pyridazinyl derivative (I) and its use as a reference compound in the determination of potentially genotoxic impurities in levosimendan samples. An analytic method for the determination of potentially genotoxic impurities in levosimendan samples wherein (I) is used as a reference compound. Levosimendan is a medicament useful in the treatment of heart failure.

Abstract: A method of testing the purity or stability to degradation of a sample of lamotrigine or a pharmaceutical dosage form comprising lamotrigine comprises assaying the said sample for the presence of a compound selected from 3-amino-6-(2,3-dichlorophenyl)-1,2,4-triazine-5-(4H)-one (compound A) and N-[5-amino-6-(2,3-dichlorophenyl)-1,2,4-triazine-3-yl]-2,3-dichlorobenzamide (compound B). A process for producing compound B, which is novel, is also disclosed.

Abstract: The present invention provides an improved method for using the measurement of total urinary 17 KS-S, referred to herein as the urinary Anabolic/Catabolic Index (ACI), as part of a biomarker for biological age.

Abstract: Disclosed is an improved method for the detection of creatinine in a fluid test sample by contacting the test sample with cupric ions, a hydroperoxide, citrate and an oxidizable dye which gives a colored response in the presence of oxygen free radicals and a pseudoperoxide. The improvement involves stabilizing the reagent formulation by the addition thereto of an ionizable phosphate containing compound such as phytic acid.

Abstract: Long wavelength, narrow emission bandwidth fluorecein dyes are provided for detecting spacially overlapping target substances. The dyes comprise 4,7-dichlorofluoresceins, and particularly 2',4',5', 7'-tetrachloro-4,7-dichloro-5- (and 6-) carboxyfluoresceins. Methods and kits for using the dyes in DNA analysis are provided.

Abstract: The invention relates to a process for the in vitro diagnosis of allergic, in particular also pseudo-allergic, immunological and environment-related disorders using live biopsy tissue samples. Also disclosed is a mobile incubation device for keeping the tissue samples alive and functioning. The samples can be, for example, skin or mucous membrane particles. The biopsy sample (14) once removed from the patient is placed in a temperature-controlled oxygen-containing incubating medium (16) and an allergen is introduced, triggering an immediate reaction (a so-called type 1 allergy). The secretion of immunoglobulin E (IgE) or a mediator is then determined qualitatively and/or quantitatively. Suitable mediators are histamine, tryptase, ECP, MPO, DAO, TPS, interleukins, prostaglandins or cytokines. The proposed mobile incubation device is provided with a temperature-controllable incubator for sample holders inside a housing. The sample containers can be filled with a nutrient solution.

Abstract: The present invention involves an improvement to an assay for the activity of a metal chelate, such as copper II/creatinine, which activity is related to the concentration of the analyte in a fluid test sample. In carrying out the assay, there is combined the fluid test sample, the metal chelate or precursors thereof, a hydroperoxide, an oxidizable indicator and a pyrazole derivative which inhibits the ability of hemoglobin to oxidize the oxidizable dye.

Abstract: Disclosed is an improvement to the assay for creatinine in fluid test samples by contacting the test sample with a reagent formulation containing cupric ions, a hydroperoxide and an oxidizable dye. The improvement involves the inclusion of one or more selected quinolines in the reagent formulation. When the quinoline is substituted with methyl in the 2-5 position and/or a methoxy in the 2-6 position auto-oxidation of the oxidizable dye is reduced. When the quinoline is further substituted in an otherwise unsubstituted carbon atom in the 2-8 position, the assay's resistance to interference from hemoglobin and ascorbate is increased.

Abstract: The present invention provides a creatinine sensor material having a first layer of a protonated pH sensitive fluorophore immobilized in a hydrophobic polymer, wherein the fluorophore can react quantitatively with ammonia and the transducing moiety of the fluorophore is neutrally charged when deprotonated; a second layer of creatinine deiminase and a polymer; and a third layer of a polymer. The present invention also provides a method for detecting creatinine using the creatinine sensor material and optical sensing devices that incorporate the creatinine sensor material.

Abstract: An assaying system for determining the presence of particular illicit substances in human physiological fluid, consisting of a collection cup, a collection cup lid, and a test card with assaying means, quality control means and adulteration detection means which is secured to the collection cup lid. The assaying means contemplate the addition of control positives such that a pre-determined number of assaying systems would be configured so that a false positive indication would be given by the assaying means in addition to any true positive results which may be present. Accordingly, it would initially be impossible to distinguish true test-positives from control positives, and thus the anonymity of a true test-positive donor individual would be protected. All donor individuals testing negative would be immediately discernible.

Abstract: Long wavelength, narrow emission bandwidth fluorecein dyes are provided for detecting spacially overlapping target substances. The dyes comprise 4,7-dichlorofluoresceins, and particularly 2',4',5',7'-tetrachloro-4,7-dichloro-5- (and 6-) carboxyfluoresceins. Methods and kits for using the dyes in DNA analysis are provided.

Abstract: Reagent and method are offered for the screening of the functional condition of the body by the person's saliva. Reagent presents itself as an H2O solution, containing ions of Fe3+, chloride ions and multi-atom alcohol .n the concentrations 0.05-3.0M; 0.05-4.0M, and 0.1-5.0M accordingly. Screening is conducted by means of mixing of the persons saliva with the reagent in the following comparison of colour mix with control; during this an orange colour is correlated with the norm; yellow-diabetes SD-1, functional disorders of pancreas; bright-pink and red initial stages of hypertonic disease, diabetes SD-2, pathological influence of smoking; dark-red, developed forms of hypertension, diabetes SD-2, pathogenic-influence of smoking or other toxic substances, leading to the emphasized energetic disorder.

Abstract: A method for assessing or determining alcohol consumption rates including using a blood specimen from a human subject to develop an individual blood constituent panel; comparing the individual panel with a reference blood constituent panel to provide categories corresponding to rates of alcohol consumption; and identifying the category of consumption rate. The methods of the invention can be varied through modification of one of several statistical models used therewith to preferentially weigh the analysis and identify one consumption category over another. Multi-variate and similar such statistical techniques correlate comparisons of individual/subject blood and reference panel constituents with recognized consumptions rates.

Abstract: The present invention provides synthetic combinatorial libraries of organic compounds based on the quinazolinone ring.

Abstract: Disclosed is a method for the determination of creatinine in urine which involves contacting a urine test sample with a reagent system containing Cu.sup.+2, a hydroperoxide and an oxidizible dye which provides a detectable response when oxidized in the presence of a pseudoperoxide. The reagent system also includes a buffer to maintain the urine's pH within the range of 6.6 to 8.0 and a chelating agent for the cupric ions to prevent oxidation of the dye in the absence of creatinine.

Abstract: Purified preparations of PMPA are provided, together with analytical methods for the detection of undesired contaminants in PMPA preparations. The PMPA compositions of the invention are of particular utility in therapeutics intended for the treatment or prophylaxis of viral infections.

Abstract: A dry analytical element comprising at least one water-permeable reagent layer and a porous spreading layer laminated in this order on a support, wherein at least one layer which is the water-permeable reagent layer, the porous spreading layer or an optional water-permeable layer contains a water-soluble polybasic amino carboxylic acid which is an ampholyte. By applying an analytical element of the invention, an analyte can be measured at a high sensitivity using a small amount of an enzyme, etc., and shelf file can be extended.

Abstract: A solid phase capable of detecting the presence of nicotine and/or nicotine metabolites is described. The solid phase is impregnated with assay reagents including a color determinant, a buffer, a cyanogen releasing agent and a cyanogen halide forming agent. The solid phase provides a means whereby unprocessed urine samples over a wide range of different pH values can be tested for the presence of nicotine and/or nicotine metabolites. The assay results may be determined by direct visualization of the color of the solid phase. Also described are methods of preparing and using the solid phase, and kits containing the solid phase.

Abstract: The present invention is a method for the detection of hydrogen peroxide in biological fluids or an aqueous solution which involves contacting the solution with an oxidation-reduction indicator and a transition metal complex. The transition metal complex is either a creatinine coordinated with iron or a guanidine coordinated with iron.

Abstract: A method for diagnosing the likelihood of autism in patients is provided which comprises first obtaining from the patient a sample of body fluid such as urine and analyzing the sample to determine the quantity therein of at least one marker compound selected from the group consisting of citramalic acid, 5-hydroxy-methyl-2-furoic acid, 3-oxo-glutaric acid, furan-2,5-dicarboxylic acid, tartaric acid, furancarbonylglycine, arabinose, dihydroxyphenylpropionic acid, carboxycitric acid and phenylcarboxylic acid; if the quantities of one or more of the compounds are abnormally high, as compared with the urine of non-autistic individuals, an ultimate diagnosis of autism is likely. The invention also pertains to a method of treating autistic patients by administration of antifungal drugs, in order to ameliorate the clinical symptoms of autism.

Abstract: Disclosed is a dry reagent system involving an absorbent carrier incorporated with a dye precursor which undergoes a detectable response in the presence of creatinine under strongly basic conditions and which also contains a moderating agent for the strong base which is a polyglycol or a polymerized quaternary ammonium salt.

Abstract: The caffeine content of a beverage is measured by inserting a dipstick into the beverage. The dipstick is impregnated with a reagent that changes color when reacted with caffeine. The degree of color change will be proportional to the concentration of caffeine in the beverage. The dipstick may be provided with a graded color chart which can be compared to the color of the dipstick so as to ascertain the concentration of caffeine in the beverage. The dipstick will preferably include a beverage dipping section; an adjacent temperature moderation section; and an adjacent reagent-impregnated section. The beverage is preferably wicked from its container to the reagent-impregnated section of the dipstick. In this manner, the reagent is never directly admixed with the beverage in the container.

Abstract: Disclosed is an improvement to the method for the detection of creatinine in which creatinine, in aqueous solution, is contacted with a dry reagent system of an indicator for creatinine. The assay is carried out at a pH above about 11.5 which is maintained by an alkaline material. The improvement involves packaging the reagent system with a material capable of absorbing CO.sub.2 and at least some ambient water vapor. This inhibits the formation of carbonic acid thereby reducing the neutralization of the alkaline reagent system during storage to increase the shelf life and decrease the variability of the system.

Abstract: Methods of cleavage of a polymer of deoxyribonucleic acid using photosensitive texaphyrins are disclosed. A preferred method of use is the site-specific cleavage of a polymer of deoxyribonucleic acid and a preferred texaphyrin is a derivatized texaphyrin having binding specificity, in particular, a texaphyrin covalently coupled to a site-directing molecule, preferably an oligonucleotide.

Abstract: In a method of determining creatinine clearance for detecting and monitoring renal dysfunction, spot samples of urine and blood from a person are obtained. Specific gravity or osmolality and creatinine concentration of the urine sample are measured. Creatinine concentration of plasma of the blood sample is also measured. Creatinine clearance is calculated as a function of the measured urine specific gravity or osmolality, the measured urine creatinine concentration and the measured plasma creatinine concentration.

Abstract: The present invention is directed to chromophoric probes for use in detecting nucleic acid sequences. More particularly, the invention is directed to probes that comprise a texaphyrin chromophore molecule covalently coupled or conjugated to a site-directing molecule, the site-directing molecule having affinity for a biological receptor or a nucleic acid sequence. In one embodiment of the invention, the probe comprises a texaphyrin chromophore conjugated to an oligonucleotide having complementary binding affinity for a target nucleic acid sequence.

Abstract: A improved method for preparing a concentrated meconium extract containing basic and acid-neutral target analytes present in a meconium sample suspected of containing the target analytes is provided. The meconium sample is extracted with a mixed solvent of acetonitrile and a volatile organic acid and the resulting organic phase is separated. The organic phase is diluted with water to provide an organic solution which is passed through a mixed mode solid phase extraction column having strong cation exchange and hydrophobic functionality. Acid-neutral and basic target analytes are sequentially eluted from the column and the eluates are combined to form a combined extract. The combined extract is evaporated to dryness and reconstituted in buffer to provide a clean concentrated neonatal meconium extract for use in qualitative and quantitative analyses.

Abstract: The present invention relates to polymeric luminophores which contain ruthenium, osmium, and rhenium complexes covalently attached to polymer matrices. The polymeric luminophores are capable of having their luminescence quenched by molecular oxygen and may be coated on optical fibers to form sensing elements to detect oxygen in gases and fluids.

Abstract: A family of benzochlorins, a family of verdins, a family of porphyrin derivatives and metal complexes thereof are disclosed. The benzochlorins have the formula of FIG. 3 of the attached drawings; their metal complexes have the formula of FIG. 1. The verdins have the formula of FIG. 4 of the attached drawings; their metal complexes have the formula of FIG. 2. The porphyrin derivatives have the formula of FIG. 7 of the attached drawings; their metal complexes have the formula of FIG. 8. Solutions of the benzochlorins, verdins, porphyrin derivatives and metal complexes which are physiologically acceptable for intravenous administration are also disclosed, as are emulsions or suspensions of the solutions, and compositions which additionally include cyclodextrin, and wherein the molecules of the benzochlorin, verdin, porphyrin derivative or metal complex are encapsulated within the molecules of the cyclodextrin. The solvent for the solutions can be a product of the reaction of ethylene oxide with castor oil.