Abstract: Disclosed is a method for reducing measurement errors due to inhibition of catalase by azide in a method for quantification of a component to be measured, in which hydrogen peroxide derived from a component other than the component to be measured is decomposed by a catalase. The method for reducing measurement errors due to inhibition of catalase by azide employs a catalase which has a subunit having a molecular mass of 75 kDa or higher and is derived from a microorganism, when hydrogen peroxide derived from a component other than the component to be measured is decomposed by the catalase followed by quantification of hydrogen peroxide derived from the component to be measured to quantify the component to be measured.

Abstract: Reagents, assays, methods, kits, devices, and systems for rapid measurement of cholesterol and cholesterol sub-fractions from a blood sample are provided. Total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol can be measured in a single assay using kinetic measurements, under conditions in which cholesterol sub-species are converted to a detectable product at distinct rates. The detectable product is measured at different times after assay initiation. A lipase, cholesterol esterase, cholesterol oxidase and a peroxidase may be used together to produce colored product in amounts directly proportional to the quantity of cholesterol converted. Methods for calculating very-low density lipoprotein cholesterol levels by further including triglyceride measurements are disclosed.

Abstract: A method for separating and collecting cell-free plasma by finger stick that minimizes contamination with genomic DNA from a donor. The method comprising placing a tourniquet on one of the digits of the donor's finger to apply pressure, lancing the digit to create an incision in the digit, and collecting blood from the incision from the incision site. The collected blood is placed on a separation membrane wherein the separation membrane is in contact with a collection membrane and both the separation and collection membrane are inserted into a substrate configured to provide overlap between the membranes. A kit and instructions for carrying out the method is also provided.

Abstract: The problem of confirming the presence of an adulterant in a urine sample is solved by the use of a reagent capable of reacting with uric acid and non-urate markers in a urine sample. In one embodiment, a phosphotungtate reagent is used to react with the urine sample to create a blue coloration in the presence of uric acid or uric acid equivalents. A reduction or elimination of the blue coloration, resulting in a reduction in the light absorbance, of the urine sample can be used as an indicator of the historical presence of an adulterant. An Oxidant History test can also be generated using the phosphostungtate reagent, wherein the light absorbance resulting from the blue coloration is measured over time, with a measured reduction in the absorbance being an indication that an adulterant is or has been present in the urine sample and is oxidizing the uric acid and non-urate markers over time.

Abstract: A substrate for positioning a separation membrane and a collection membrane for separating and collecting plasma is disclosed. The substrate includes an inner flexure disposed proximate to a first peripheral portion of the substrate and an outer flexure disposed surrounding at least a portion of the inner flexure. The inner flexure is formed from a plurality of first slots in the substrate and the outer flexure is formed from a plurality of second slots in the substrate.

Abstract: This invention discloses a reagent composition for a biosensor having high sensitivity which is capable of improving analysis linearity of an analyte such as glucose by reacting an oxidoreductase, a metal-containing complex, and Naphthol Green B, and minimizing blood necessary for measuring blood glucose since it is possible to detect a concentration of a small amount of the analyte, and a biosensor having the same. The reagent composition for a biosensor includes at least two kinds of electron transfer mediators including Naphthol Green B, and an enzyme.

Abstract: A method for assaying bilirubin in which a dry reagent is used, which is capable of accelerating the reaction of bilirubin oxidase, and an assay instrument to be used in the method for assaying bilirubin, are provided. The method for assaying bilirubin is characterized in that a biological sample and a bilirubin oxidase-containing dry reagent are mixed first, and then the mixture obtained and a surfactant-containing dry reagent are mixed. An assay instrument (1) to be used in bilirubin assay is characterized in that a bilirubin oxidase and a surfactant are arranged in any of a sample supply part (11), passages (12, 13, 14), and a detection part (15) in a manner such that the bilirubin oxidase is positioned closer to the sample supply part (11) than the surfactant is.

Abstract: Provided are an analytical instrument and an analytical method that allow for the direct analysis of a target substance in an undiluted specimen by a transmission photometry in a tightly closed cell container space. An analytical instrument is an analytical instrument for analyzing a target substance contained in a specimen flown in the tightly closed cell container by utilizing an oxidative color-developing agent and an oxidative enzyme reaction, in which an upper substrate and a lower substrate are arranged facing each other and at least a part of the upper substrate and/or at least a part of the lower substrate are/is made of a material transmitting light used for the analysis and having oxygen transmission properties.

Abstract: The invention relates to a microfluidic micromechanical system having integrated active elements (7) and a method for microfluidic process control in a microfluidic micromechanical system. According to the invention, the microfluidic system comprises integrated active elements (7), which can be activated without auxiliary energy by means of ambient variables that can be influenced and which are designed to bring about active functions as a result of the change of the swelling state thereof or the mechanical properties thereof. The microfluidic micromechanical system further comprises at least one structural support (2) having at least one first (3) and one second (4) channel, wherein a reaction chamber (6) bounded by active elements (7) is formed in an overlapping region (5) of the first and second channels.

Abstract: A technique is provided for base recognition in an integrated device is provided. A target molecule is driven into a nanopore of the integrated device. The integrated device includes a nanowire separated into a left nanowire part and a right nanowire part to form a nanogap in between, a source pad connected to the right nanowire part, a drain pad connected to the left nanowire part, and the nanopore. The source pad, the drain pad, the right nanowire part, the left nanowire part, and the nanogap together form a transistor. The nanogap is part of the nanopore. A transistor current is measured while a single base of the target molecule is in the nanogap of the nanopore, and the single base affects the transistor current. An identity of the single base is determined according to a change in the transistor current.

Abstract: Genome-wide association studies (GWAS) was recently used to identify SNPs in a genomic region on chromosome 4 that associate with serum urate levels and gout. The present disclosure shows that human ATP-binding cassette, subfamily G, 2 (ABCG2), encoded by the ABCG2 gene contained in this region, is a hitherto unknown urate efflux transporter. The present disclosure further shows that native ABCG2 is located in the brush border membrane of kidney proximal tubule cells, where it mediates renal urate secretion. Introduction of the mutation Q141K encoded by the common SNP rs2231142 by site-directed mutagenesis resulted in reduced urate transport rates compared to wild-type ABCG2. Data from a population-based study of 14,783 individuals support rs2231142 as the causal variant in the region and show highly significant associations with urate levels and gout.

Abstract: Methods and apparatus relating to very large scale FET arrays for analyte measurements. ChemFET (e.g., ISFET) arrays may be fabricated using conventional CMOS processing techniques based on improved FET pixel and array designs that increase measurement sensitivity and accuracy, and at the same time facilitate significantly small pixel sizes and dense arrays. Improved array control techniques provide for rapid data acquisition from large and dense arrays. Such arrays may be employed to detect a presence and/or concentration changes of various analyte types in a wide variety of chemical and/or biological processes. In one example, chemFET arrays facilitate DNA sequencing techniques based on monitoring changes in hydrogen ion concentration (pH), changes in other analyte concentration, and/or binding events associated with chemical processes relating to DNA synthesis.

Abstract: Provided are an analytical instrument and an analytical method that allow for the direct analysis of a target substance in an undiluted specimen by a transmission photometry in a tightly closed cell container space. An analytical instrument is an analytical instrument for analyzing a target substance contained in a specimen flown in the tightly closed cell container by utilizing an oxidative color-developing agent and an oxidative enzyme reaction, in which an upper substrate and a lower substrate are arranged facing each other and at least a part of the upper substrate and/or at least a part of the lower substrate are/is made of a material transmitting light used for the analysis and having oxygen transmission properties.

Abstract: Chemiluminescent detection of metabolic by-products of inosine and hypoxanthine to diagnose ischemic events such as early acute cardiac ischemia.

Abstract: A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.

Abstract: The present invention relates to a dry stick test device for the determination of an analyte in a sample by means of a chemical assay. The device comprises: (i) optionally a solid support, (ii) at least one reagent pad comprising a reagent capable of reacting with the analyte, a derivative of said analyte or an indicator compound for said analyte to provide a detectable signal when in moistened state, and (iii) a development pad which is located in contact with the at least one reagent pad, optionally between the solid support and the at least one reagent pad, said development pad comprises at least one controlling compound capable of providing a condition required for the reagent to react with the analyte to provide a detectable signal, wherein the at least one reagent pad and the development pad are arranged to avoid precipitation of sample component(s) on the top-face of the device.

Abstract: A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.

Abstract: A method for determining a concentration of an analyte is disclosed. The method includes applying a potential excitation to a fluid sample containing an analyte and determining if a current decay curve associated with the fluid sample has entered an analyte depletion stage. The method also includes measuring a plurality of current values associated with the fluid sample during the analyte depletion stage and calculating an analyte concentration based on at least one of the plurality of current values.

Abstract: A biosensor manufacturing method including a sheet material forming process and a dicing process. In the sheet material forming process a sheet material with plural biosensor forming sections is formed. Each of the biosensor forming sections includes a first base plate, a second base plate stacked on the first base plate and forming a capillary between the second base plate and the leading end portion of the first base plate for sucking in sample liquid, and a hydrophilic layer formed on the second base plate at least in a region facing the capillary. In the dicing process plural biosensors are obtained by dicing the sheet material with a blade from the first base plate side at the leading end of each of the biosensor forming sections, such that the leading end of the capillary opens onto the leading end face of the first base plate and the second base plate.

Abstract: Chemiluminescent detection of metabolic by-products of inosine and hypoxanthine is used to diagnose ischemic events such as early acute cardiac ischemia.

Abstract: A test strip or electrochemical sensor for measuring the amount of an analyte in a biological fluid, e.g. the glucose content of whole blood, includes a size self-limiting reagent formulation employing an enzyme system for reaction with the analyte, the reactive system mixed into a water-soluble swellable polymer matrix containing small water-insoluble particles having a nominal size of about 0.05 to 20 ?m, preferably about 1 to 10 ?m. The weight ratio of the water-insoluble particles to the water-soluble swellable polymer matrix is about 1/2 to 2/1. The reagent formulation is deposited onto a non-porous substrate to form a thin layer about 6-16 ?m thick, providing a rapid and stable response to application of a sample, while being insensitive to the amount of the sample.

Abstract: Methods of modulating the immune response using pharmaceutical compositions containing crystalline adjuvants are described. In various embodiments the crystalline adjuvants are selected from the group consisting of monosodium urate (MSU), xanthine, basic calcium phosphate (BCP), calcium pyrophosphate dihydrate (CPPD), hydroxyapatite, calcium oxalate, cholesterol, lipid liquid, other crystalline lipids, lithium heparin, talc, and starch.

Abstract: Disclosed herein is a dry fluorescence biosensor strip for rapid detection of a target analyte present in bodily fluids. The dry fluorescence biosensor strip comprises a sample receptacle and a dry detection membrane. The sample receptacle receives a sample of one of the bodily fluids. The dry detection membrane detects presence of the target analyte in the received sample based on fluorescence induced on the dry detection membrane. Fluorescent signals are emitted from the dry detection membrane on induction of fluorescence. A fluorometer quantifies measurable properties of the target analyte based on the emitted fluorescent signals. The dry fluorescence biosensor strip may further comprise a filtration membrane for filtering the received sample. The filtered sample migrates from the filtration membrane to the dry detection membrane. The dry detection membrane may then detect presence of the target analyte in the filtered sample.

Abstract: The present invention relates to a method for analyzing residual agricultural chemicals which comprises the steps of acting a reduced glutathione as a reactive substrate and a glutathione transferase serving as a catalyst for the reaction on a carbofuran derivative or a methomyl derivative as a carbamate type agricultural chemical of a new series to thus derivatize the agricultural chemical into a substance having a high choline esterase-inhibitory activity; reacting the substances formed through the derivatization reaction with a choline esterase; and then detecting the presence of the agricultural chemical as the new series of carbamate type one included in a sample to be examined on the basis of the changes in the choline esterase activity thus detected.

Abstract: It is intended to clarify a transportation system participating in the uric acid uptake in vascular smooth muscle cells (VSMCs) and provide a novel remedy, a preventive or a treating agent for vascular disorders, hypertension and renal disorders with the use of a drug participating in this transportation system. It is also intended to provide a novel screening system for a remedy, a preventive or a treating agent for vascular disorders, hypertension and renal disorders with the use of such a transportation system.

Abstract: Provided is a method of storing a reagent in a microfluidic device. The reagent, in a liquid form, is loaded into reaction chambers arranged on the microfluidic device; followed by lyophilization as being contained in the microfluidic device.

Abstract: A test strip or electrochemical sensor for measuring the amount of an analyte in a hiological fluid, e.g., the glucose content of whole blood, includes a size self-limiting reagent formulation employing an enzyme system for reaction with the analyte, the reactive system mixed into a water-soluble swellable polymer matrix containing small water-insoluble particles having a nominal size of about 0.05 to 20 ?m, preferably about 1 to 10 ?m. The weight ratio of the water-insoluble particles to the water-soluble swellable polymer matrix is about 1/2 to 2/1. The reagent formulation is deposited onto a non-porous substrate to form a thin layer about 6-16 ?m thick, providing a rapid and stable response to application of a sample, while being insensitive to the amount of the sample.

Abstract: Disclosed herein is a dry fluorescence biosensor strip for rapid detection of a target analyte present in bodily fluids. The dry fluorescence biosensor strip comprises a sample receptacle and a dry detection membrane. The sample receptacle receives a sample of one of the bodily fluids. The dry detection membrane detects presence of the target analyte in the received sample based on fluorescence induced on the dry detection membrane. Fluorescent signals are emitted from the dry detection membrane on induction of fluorescence. A fluorometer quantifies measurable properties of the target analyte based on the emitted fluorescent signals. The dry fluorescence biosensor strip may further comprise a filtration membrane for filtering the received sample. The filtered sample migrates from the filtration membrane to the dry detection membrane. The dry detection membrane may then detect presence of the target analyte in the filtered sample.

Abstract: A method of detecting oxidants in a biological sample comprising: adding a source of ferrous ions to said sample, whereby the presence of oxidants in said sample oxidize at least a portion of said ferrous ions to ferric ions; adding a chromogenic compound to said sample, whereby said chromogenic compound reacts with at least a portion of any ferric ions present in said sample; and detecting for the product of said chromogenic compound-ferric ion reaction; whereby the detection of said chromogenic compound-ferric ion reaction product indicates the presence of oxidants in said sample. The method of detecting adulteration of a urine sample also comprises adding a source of ferrous ions to a urine sample; adding a chromogenic compound to said urine sample; detecting the presence or absence of a chromogenic reaction product; determining a concentration of said chromogenic reaction product; and determining if said concentration signifies adulteration of said urine sample.

Abstract: The present invention involves the early diagnosis of cancerous or precancerous conditions in the gastrointestinal tract by detection of a backleak of signature proteins or carbohydrates in a biological sample obtained from the gastrointestinal tract.

Abstract: The invention provides an enzyme-based device and process for manufacture of the device in a shelf-stable form. The device consists of a dry phase test strip useful in detecting the presence and concentration of uric acid in a liquid sample (such as urine) and has a stabilized uricase-containing working solution impregnated therein. Methods for manufacturing the device to maintain the stability of the working solution, especially the enzyme components therof, are also described. A method for making the uric acid measurement in one step is also provided, wherein the one step to be performed consists of applying the liquid sample to the test strip of the device.

Abstract: A control serum for a dry process is provided that dose not show misfit in measurement values by the dry process and a wet process. The above-mentioned control serum is obtained by freezing or freeze-drying a control serum without dialysis.

Abstract: A single reagent system and a method to detect and measure oxidizing adulterants in bodily fluid being screened for drugs of abuse are disclosed. The system comprising a strip containing 0.05 to 0.2 micromole/25 sq. mm. of a benzidine derivative and is used to detect sodium hypochlorite (bleach), chlorine, hydrogen peroxide, sodium bromide, sodium iodide, sodium nitrite, and pyridinium chlorochromate adulterants in urine, sweat, saliva, blood or other bodily fluids during screening for drugs of abuse.

Abstract: Methods are provided for glucose detection and quantification in urine. The methods include selecting a test device comprising a matrix impregnated with a chromogenic indicator mixture, locating the test device to promote incidental contact of same with animal urine, reading a developed indicator color after the device has been wetted with urine, and determining the animal's urine glucose concentration.

Abstract: The present invention is directed to a reagent composition for use in detection and quantification of glucose in urine comprising a first chromogenic indicator reagent combination capable of color development to indicate the presence of a lower concentration of glucose, a second chromogenic indicator reagent combination capable of color development to indicate the presence of a higher concentration of glucose, wherein the first chromogenic indicator prevents color development of the second chromogenic indicator unless the higher concentration of glucose is present, a scavenger that prevents color development of the first indicator reagent composition unless a threshold concentration of glucose is present.

Abstract: A method for determining the presence and/or the amount of an analyte in a sample which method comprises contacting the sample containing the analyte with a peroxidatively-active material to produce a peroxide, a substance capable of producing a detectable response in the presence of the peroxide as a measure of the analyte present in the sample, and a microperoxidase catalyst.

Abstract: The present invention relates to an enzyme sensor for measuring the concentration or activity of an analyte in a test fluid. The sensor has at least one enzyme layer comprising an immobilized enzyme for which the analyte is a substrate. The immobilized enzyme is obtained by formation of one or more covalent link(s), optionally by using a cross-linking agent, between the enzyme and at least one type of macromolecule in the presence of a competitive inhibitor for said enzyme. The present invention also relates to a membrane for an enzyme sensor. Furthermore, the invention relates to a method for stabilizing the enzymatic activity of an enzyme sensor.

Abstract: A urine test for cancer is disclosed for the detection of a broad spectrum of cancers in which the specimen of urine from the subject to be tested is placed into a test tube, a concentrated acid is added to the specimen and the resulting mixture is heated to the boiling point. The mixture is then cooled to ambient temperature, ethyl ether is added and mixed well into the mixture and the mixture is left to stand. The change in color of the mixture of from pink to purple indicates the presence of cancer in the subject and no change in color indicates the absence of cancer.

Abstract: The present invention is directed to the determination of unconjugated and unbound bilirubin in a sample.

Abstract: A method of determining the number of bacteria in a sample which involves introducing a sample containing bacteria into a tubular filtering vessel holding therein a hydrophobic filter for bacterial detection, a coloring composition is disposed on the side of the filter where the sample is introduced into the vessel, and a support for the filter is disposed on the opposite side of the filter from the coloring composition. The bacteria is subjected to and the sample is filtered dyeing sample by suction from the support to collect the dyed bacteria on the filter and remove the excess of coloring matter. The number of the bacteria in the sample is determined from the degree of staining of the filter.

Abstract: Provided is a method of determining the amount of cholesterol in high-density lipoprotein (HDL), which comprises reacting an HDL-containing sample with cholesterol esterase and cholesterol oxidase or cholesterol dehydrogenase in the presence of a reagent for aggregating lipoproteins- except HDL, and determining the amount of hydrogen peroxide or reductive co-enzyme formed therein.

Abstract: An assay for detecting in a test sample, an analyte that undergoes auto-oxidation is disclosed. The assay comprises the steps of forming a reaction mixture by combining in an aqueous medium (i) a sample containing the analyte and (ii) a stabilizer that reduces the rate of radical mediated auto-oxidation of the analyte. The reaction mixture is incubated for a period of time and the rate of auto-oxidation is detected. When the detected rate of auto-oxidation is substantially zero, a sufficient quantity of an enzyme is added, that catalyzes the oxidation of the analyte. In the presence of the stabilizer, the analyte can be oxidized to a product species. The product species, the analyte, or both can be detected.

Abstract: An improved method of diagnosing preeclampsia comprising the steps ofa. collecting blood from a pregnant female mammal; andb. detecting in said blood significantly elevated levels of at least one substance selected from the group consisting of:(1) a hemoglobin variant or hemoglobin variant precursor and(2) a red blood cell glycolytic enzyme or a red blood cell glycolytic enzyme precursor.By detecting the presence of an appropriate "marker" in the blood, preeclampsia can be diagnosed at an earlier stage, thus making possible timely therapeutic intervention. An assay kit for detecting the markers is also provided.

Abstract: A method to produce novel polyketide structures by designing and introducing specified changes in the DNA governing the synthesis of the polyketide is disclosed. The biosynthesis of specific polyketide analogs is accomplished by genetic manipulation of a polyketide-producing microorganism by isolating a polyketide biosynthetic gene-containing DNA sequence, identifying enzymatic activities associated within the DNA sequence, introducing one or more specified changes into the DNA sequence which codes for one of the enzymatic activities which results in an altered DNA sequence, introducing the altered DNA sequence into the polyketide-producing microorganism to replace the original sequence, growing a culture of the altered microorganism under conditions suitable for the formation of the specific polyketide analog, and isolating the specific polyketide analog from the culture.

Abstract: An assay for detecting in a test sample, an analyte that undergoes auto-oxidation is disclosed. The assay comprises the steps of forming a reaction mixture by combining in an aqueous medium (i) a sample containing the analyte and (ii) a stabilizer that reduces the rate of radical mediated auto-oxidation of the analyte. The reaction mixture is incubated for a period of time and the rate of auto-oxidation is detected. When the detected rate of auto-oxidation is substantially zero, a sufficient quantity of an enzyme is added, that catalyzes the oxidation of the analyte. In the presence of the stabilizer, the analyte can be oxidized to a product species. The product species, the analyte, or both can be detected.

Abstract: Provided is a method of determining the amount of cholesterol in high-density lipoprotein (HDL), which comprises reacting an HDL-containing sample with cholesterol esterase and cholesterol oxidase or cholesterol dehydrogenase in the presence of a reagent for aggregating lipoproteins except HDL, and determining the amount of hydrogen peroxide or reductive co-enzyme formed therein.

Abstract: A method for the cell-free synthesis and isolation of novel genes and polypeptides is provided. Within one embodiment, an expression unit is constructed onto which semi-random nucleotide sequences are attached. The semi-random nucleotide sequences are first transcribed to produce RNA, and then translated under conditions such that polysomes are produced. Polysomes which bind to a substance of interest are then isolated and disrupted; and the released mRNA is recovered. The mRNA is used to construct cDNA which is expressed to produce novel polypeptides.

Abstract: Enzyme activity is measured promptly with a high accuracy by introducing an enzyme, the activity of which is to be measured, into a column comprising a hollow tube packed with a filler comprising a support and a substrate that can be recognized by the enzyme, which is immobilized on the support, and measuring the amount of the obtained decomposition product of the substrate.

Abstract: The present invention concerns a method of enzymatically determining the pH of a specimen (e.g., a solution or a biological fluid) and a kit for conducting the method. The present method involves mixing (1) a specimen with (2) an enzyme and (3) one or more substrates for the enzyme in a buffered solution having a pH effective to provide a direct proportional relationship between the activity of the enzyme and the pH of the specimen; determining the activity of the enzyme; and correlating the activity of the enzyme to the pH of the specimen. Each of the sample, the enzyme, the substrate and the buffered solution is present in an amount effective to provide the direct proportional relationship between the activity of the enzyme and the pH of the specimen.

Abstract: A test kit for the rapid detection of the bacteria Helicobacter pylori in gastric biopsy tissue to diagnose gastric disease is described which includes a chemical test composition for the bacteria, a tray-like means including means to visibly display the test composition, means to handle a biopsy specimen and insert it in the test composition, and indicia to determine the results of the test.