Abstract: Gels and gel-containing materials, including hydrogels, are described. A gel can be formed by blending polyacrylic acid (PAA) and a polyglycol, such as polytetramethylene ether glycol (PTMEG) at room temperature and, in some cases, without using a catalyst. The blend material can be used to form soft or hard materials, films and particles. The blend material can be combined with vinyl monomers and polymerize to form a hydrogel. The hydrogel can have a high mechanical strength and high water absorbency.

Abstract: An improved quality assurance system and method for point-of-care testing are disclosed. The present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care without the need for running liquid-based quality control materials on the analysis system. Quality assurance of a quantitative physiological sample test system is performed without using a quality control sample by monitoring the thermal and temporal stress of a component used with the test system. Alert information is generated that indicates that the component has failed quality assurance when the thermal and temporal stress exceeds a predetermined thermal-temporal stress threshold. Alternatively, the present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care by minimizing the need for running liquid-based quality control materials on the analysis system.

Abstract: An analyte sensor and a method for making the analyte sensor are disclosed. The analyte sensor includes a crosslinked, hydrophilic copolymer having a methacrylate-derived backbone and a side chain having a negatively charged group. The copolymer can include an embedded analyte sensing component, and can be adjacent to a surface of an electrode, or be adjacent to a sensing membrane that that has an embedded analyte sensing component and is adjacent to a surface of an electrode. The sensing membrane can have a crosslinked network of crosslinked proteins.

Abstract: A hematocrit (HCT) measurement system and measurement method using the same are disclosed. The hematocrit (HCT) measurement system comprises a test strip and a measurement apparatus comprising: a connector transmitting an initial signal generated from a blood sample to the measurement apparatus, a capacitive reactance adjustor disposed between the test strip and the measurement apparatus, a calculation unit for calculating concentration and HCT value of the blood sample, an A/D convertor transforming the corresponding initial signal to a digital signal, and a signal processor processing the digital reacted signal and showing measured results on a display, wherein the HCT value is calculated by voltage partition to prevent the signal waveform voltage being saturated or cutoff, thereby resulting in measured signal distortion.

Abstract: In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a base, a first electrode and a second electrode wherein a thermocouple portion is provided integral with the second electrode thereby enabling on-sensor temperature measurement capability. In some embodiments, two and only two electrical contact engagement portions are provided thereby simplifying electrical contact. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Abstract: Provided is a method for measuring cholesterol in high-density lipoprotein (HDL) simply and accurately. A method for measuring cholesterol in high-density lipoprotein in a specimen, comprising reacting the specimen with i) a cholesterol ester hydrolase and a cholesterol oxidase, or ii) a cholesterol ester hydrolase, an oxidized coenzyme, and a cholesterol dehydrogenase, in an aqueous medium comprising at least one substance selected from the group consisting of pyridinium salts and quaternary ammonium salts each having a specific structure, and a polyanion to form hydrogen peroxide or reduced coenzyme and measuring the formed hydrogen peroxide or reduced coenzyme.

Abstract: An object of the present invention is to provide: a novel gene (polynucleotide) encoding an FAD-conjugated glucose dehydrogenase having excellent properties that it has excellent reactivity to glucose, excellent thermal stability, and excellent substrate-recognition performance and also has a low activity for maltose; a process for the production of the enzyme using a transformant cell transfected with the gene; and a method for the determination of glucose, a reagent composition for use in the determination of glucose, a biosensor for use in the determination of glucose and others, each characterized by using the enzyme obtained.

Abstract: There is provided a lateral flow immunoassay test device. The test device comprises a test strip. The test strip comprises a test membrane having a translucent section including a control zone and a test zone. The device is adapted to house the test strip such that at least the translucent section is exposable to ambient light. The device comprises a backing structure for backing the test strip which comprises a first optical detector for detecting ambient light which has passed through the test zone, and a second optical detector for detecting ambient light which has passed through the translucent section in a further zone outside of the test and control zones. Using the detector outputs an amount of analyte in a test liquid may be calculated.

Abstract: The present invention relates to a strip for an improved lateral flow assay of a biological sample on a single plane and a lateral flow chromatography assay using a test device containing the same. The strip of the present invention consists of a single-pad, which can improve lateral flow assay by providing an easy and simple procedure and clear visual reading. The strip of the present invention is consisted of sample application (sample) zone and reactant-resultant zone where the reaction mixture is deposited (reactant) are all on a same plane. In addition, the present invention provides a chromatographic method wherein hemoglobin is separated from analyte by a differential chromatography on the solid phase. Any interference of detection of the result by hemoglobin is removed by the present invention. The present invention provides advantages including an easy and simple procedure with a quick and clear response.

Abstract: The present invention relates to novel bacteria and the uses thereof. The invention particularly relates to bacteria having a metabolic pathway ratio between pentose phosphate and glycolysis greater than 0.5, and their uses in the chemical, pharmaceutical and agro-chemical industries, e.g., for producing compounds of industrial interest.

Abstract: A chromogenic absorbent material and related chromogenic solution, use, process and application for an animal litter. The chromogenic absorbent material includes an absorptive material for absorbing an animal excretion; an oxidizing agent responsive to peroxidatic/pseudoperoxidatic activity in the animal excretion to provide oxidizing activity; and an inclusion complex including a host compound and a guest compound, the guest compound being a chromogenic indicator associated with the host compound and being chromogenically responsive to the oxidizing activity of the oxidizing agent. The chromogenic absorbent material may be prepared from the chromogenic solution including the oxidizing agent and the inclusion complex. The chromogenic absorbent material may be used as particles combined with animal litter for detection of peroxidatic/pseudoperoxidatic activity in the animal excretion.

Abstract: This disclosure provides systems, devices, and methods for capturing and measuring surface topography. This disclosure provides a high resolution retrographic sensor comprising a volume of elastomer and a thin, opaque reflective membrane. The reflective membrane is arranged to conform to a specimen that contacts it. The disclosure provides a high resolution visualization system comprising the retrographic sensor and an illumination source. Also provided are high resolution measurement systems comprising the retrographic sensor, an illumination source, an imaging device, and a processing component.

Abstract: Storage containers for storing at least one diagnostic test element including an enzyme and a stabilized coenzyme are disclosed. In addition, diagnostic products which include diagnostic test elements including an enzyme and a stabilized coenzyme, as well as analytical measuring devices which include such storage containers or diagnostic products, are also disclosed. Other aspects include, but are not limited to, unique methods, techniques, products, systems and devices involving test elements which include an enzyme and a stabilized coenzyme.

Abstract: Provided is a buffer composition capable of suppressing temperature dependency of the pH of a buffer solution, and a specimen analysis method and a specimen analysis system using the buffer composition, wherein the buffer composition contains a buffer substance A showing a positive correlation between temperature and pH and a buffer substance B showing a negative correlation between temperature and pH.

Abstract: Amino acid mutation(s) can be introduced to Sclerotinia sclerotiorum- or Aspergillus niger-derived glucose dehydrogenase to obtain a glucose dehydrogenase variant with significantly enhanced productivity in E. coli. The glucose dehydrogenase of the present invention is low reactive with xylose.

Abstract: Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

Abstract: An object of the present invention is to provide a novel glucose dehydrogenase, a method for producing the glucose dehydrogenase, and applications of the glucose dehydrogenase. An isolated flavin-binding glucose dehydrogenase comprising a polypeptide having an amino acid sequence with 80% or more identity to the amino acid sequence of SEQ ID NO: 1, and having glucose dehydrogenase activity is provided.

Abstract: A heat-resistant flavin-bound glucose dehydrogenase having a high substrate specificity for D-glucose, an method for producing the same, and a transformant used for the same. A flavin-bound glucose dehydrogenase gene encoding a flavin-bound glucose dehydrogenase derived from Mucor is introduced into yeast, Zygosaccharomyces, to obtain a transformant. Subsequently, the yeast transformant is cultured to obtain a flavin-bound glucose dehydrogenase from the culture. The heat-resistant flavin-bound glucose dehydrogenase is less susceptible to the effects of dissolved oxygen and allows accurate measurement of glucose even in the presence of sugar compounds other than glucose in a sample.

Abstract: An object is to provide a novel enzyme that exhibits glucose dehydrogenase activity. Furthermore, another object is to provide a novel method pertaining to enzyme modification. Provided is a mutated enzyme containing an amino acid sequence wherein one or at least two amino acids selected from a group are substituted with another amino acid in the amino acid sequence of a microorganism-derived glucose oxidase.

Abstract: The present invention relates to a method for determining the presence, absence or amount of biologically active HGF in a sample, comprising the steps (i) bringing the sample in contact with a first porous solid phase comprising a HGF binding component of the extracellular matrix or cell membrane, and an indicator composition comprising bromothymol blue and a quaternary ammonium compound; and (ii) correlating the color of the porous solid phase with the presence, absence or amount of biologically active HGF in the sample. It further relates to a device comprising a first porous solid phase comprising at least one HGF-binding component of the extracellular matrix or cell membrane, and an indicator composition comprising bromothymol blue and a quaternary ammonium compound.

Abstract: A biosensor (102) for determining the presence or amount of a substance in a sample and methods of use of the biosensor (102) are provided. The biosensor (102) for receiving a user sample to be analyzed includes a mixture for electrochemical reaction with an analyte. The mixture includes an enzyme, a mediator and an oxidizable species as an internal reference.

Abstract: A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.

Abstract: An analytical device, in particular, a paper analytical device (PAD), for detection of at least two chemical components indicative of a low quality pharmaceutical product is provided. The analytical device can include a porous, hydrophilic medium, at least two assay regions associated with the porous, hydrophilic medium, at least one assay reagent or precursor thereof in the assay regions, and at least one optically readable information zone.

Abstract: A polymer matrix that may coated on an electrode is created by co-crosslinking (1) an adduct of a polyaniline formed by templated oxidative polymerization on a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme. The polymer matrix may be hydrated, and the absorbed water may make it permeable to, for example, glucose. The polyaniline may be polyaniline itself or a substituted polyaniline; the water-soluble crosslinker may be poly(ethylene glycol)diglycidyl ether, and the redox enzyme may be glucose oxidase. The polymer matrix may be produced by co-crosslinking (1) an adduct of an electrically conductive polymer and a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme in a single step at an about neutral pH, curing by drying. After hydration, the crosslinked polymer matrix may form a 3-dimensional glucose-permeable bioelectrocatalyst, catalyzing the electrooxidation of glucose.

Abstract: The invention provides methods of treating ?-galactosidase A deficiency. Dosage forms, methods of administration, and methods of analyzing human ?-galactosidase A are also included.

Abstract: A device for managing health data provides a first housing portion including a data storage system that stores health data and a second housing portion including a data communications element. The data communications element provides data communications between the data storage system and a processing device that processes the health data according to a data-management software. The first housing portion and the second housing portion are connected by a cable that communicates signals between the data communications element and other components in the first housing portion. Another device for managing health data provides a first housing portion including a health data management system and a data communications element that provides data communications between the health data management system and an external processing device. The second housing portion is removably coupled to the first housing portion, and includes at least one component used by the health data management system.

Abstract: Systems and methods for oxygen removal from aqueous solutions are presented in which a bi-enzymatic reaction sequence recycles and depletes oxygen to extinction, preferably using an oxidase and a catalase as biocatalysts and a carbohydrate as co-substrate. Contemplated systems and methods are particularly advantageous in conjunction with electrochemical reaction systems in which oxygen would adversely interfere with the reaction system.

Abstract: A polymer colorant including polymer monomer units, and at least one alizarin unit which is incorporated into the polymer and which provides color to the polymer colorant and a process for preparing the polymer colorant. An article or composition containing the polymer colorant. A toner including the polymer colorant, and optionally, one or more ingredients selected from the group consisting of crystalline polyester resins, amorphous polyester resins, colorants, waxes, coagulants, mordants, and mixtures and combinations thereof. A polymer latex including an aqueous dispersion of polymer colorant, wherein the polymer colorant comprises polymer monomer units and at least one alizarin unit which is incorporated into the polymer and which provides color to the polymer colorant; and optionally, a mordant.

Abstract: The present invention relates to a novel process for converting a substrate of formula (III) and/or (IV) into a product of formula (I) or (II) comprising the following reactions: a) oxidation of at least one terminal C-atom, b) dehydratation, c) decarboxylation and d) reduction and/or amination. At least step b is enzyme-catalyzed. In a preferred embodiment, all reactions are enzymatically catalyzed. The enzymes catalyzing the reactions are selected from oxidoreductases, decarboxylases, dehydratases and/or aminotransferases. The process may be performed in a cell-free in vitro production system or in an improved fermentative production system.

Abstract: A mobile phone case with an embedded wireless interface for enabling communications between a continuous glucose monitoring (CGM) sensor and a mobile phone is described. The mobile phone case includes an autonomous battery and an autonomous alarm speaker for enabling communication with a CGM sensor in situations where the mobile phone is unavailable.

Abstract: Novel solid-phase biosensors that utilize ink jet printing of biocompatible sol-gel based inks to create sensor strips are reported herein. Biomolecules and other reagents useful in bioassays to detect, for example, pathogenic microorganisms or toxic substances, are immobilized on a substrate, which can be paper based, by layering these substances between two layers of biomolecule compatible sol gel. The sol gel precursor solutions and solutions of the assay reagents are printed from separate nozzles in a layered approach which avoids clogging of the nozzles by the pre-mature gelling of the sol gel precursor solution. In certain embodiments of the application, a capture agent is used to concentrate a compound to be detected in specific areas on the substrate to facilitate detection.

Abstract: Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Abstract: The present invention is directed to membranes composed liquid crystals having continuous aqueous channels, such as a lyotropic liquid crystal, including a cubic phase lyotropic liquid crystal, and to electrochemical sensors equipped with such membranes. The membranes are useful in limiting the diffusion of an analyte to a working electrode in an electrochemical sensor so that the sensor does not saturate and/or remains linearly responsive over a large range of analyte concentrations. Electrochemical sensors equipped with membranes of the present invention demonstrate considerable sensitivity and stability, and a large signal-to-noise ratio, in a variety of conditions.

Abstract: A control unit obtains, from a memory unit, data of a plurality of pre-meal blood sugar levels that are blood sugar levels measured before meals and data of a plurality of post-meal blood sugar levels that are blood sugar levels measured after meals, calculates a pre-meal average value that is an average value of the plurality of pre-meal blood sugar levels, calculates a post-meal average value that is an average value of the plurality of post-meal blood sugar levels, calculates an average blood sugar level that is an average of the pre-meal average value and the post-meal average value, calculates an estimated HbA1c value using the average blood sugar level, and displays the calculated estimated HbA1c value in a display unit.

Abstract: This disclosure provides systems, devices, and methods for capturing and measuring surface topography. This disclosure provides a high resolution retrographic sensor comprising a volume of elastomer and a thin, opaque reflective membrane. The reflective membrane is arranged to conform to a specimen that contacts it. The disclosure provides a high resolution visualization system comprising the retrographic sensor and an illumination source. Also provided are high resolution measurement systems comprising the retrographic sensor, an illumination source, an imaging device, and a processing component.

Abstract: It is to provide a method for measuring glycated hemoglobin in a hemoglobin-containing sample, comprising: reacting glycated hemoglobin in the hemoglobin-containing sample with a proteolytic enzyme in the presence of at least one salt selected from the group consisting of a pyridinium salt, a phosphonium salt, an imidazolium salt, and an isoquinolinium salt; reacting the obtained reaction product with fructosyl peptide oxidase; and measuring the generated hydrogen peroxide. The present invention provides a method for accurately measuring glycated hemoglobin in a hemoglobin-containing sample.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: An apparatus and a method for the colorimetric detection testing of peroxide-based compositions is disclosed. The apparatus comprises a first carrier having an acidic compound in dry form for hydrolysis of peroxide-based compounds and a second carrier having a colorimetric detection reagent composition in dry form. The carriers are positioned with respect to a support member to facilitate transfer of a solution containing a peroxide-based compound hydrolyzed by the acidic compound when activated into contact with the reagent composition of the second carrier for observation of any resulting color indication. The method comprises steps of applying the acidic compound and colorimetric detection reagent composition is liquid forms to the respective carriers and allowing the applied formulations to dry.

Abstract: Embodiments of the present disclosure include detecting a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirming a presence of an impending hypoglycemic condition, and asserting a notification corresponding to the confirmed impending hypoglycemic condition. Devices, methods, systems and kits incorporating the same are also provided.

Abstract: A target substance can be produced by culturing a bacterium having an ability to produce 2-ketoglutaric acid or a derivative thereof, and an ability to produce xylonic acid from xylose, which is imparted with xylonate dehydratase activity, 2-keto-3-deoxyxylonate dehydratase activity and 2-ketoglutaric semialdehyde dehydrogenase activity, or in which these activities are enhanced, in a medium containing xylose as a carbon source to produce and accumulate the target substance in the medium, and collecting the target substance from the medium.

Abstract: Method and apparatus for performing a discrete glucose testing and bolus dosage determination including a glucose meter with bolus calculation function are provided.

Abstract: Reagent materials and associated test elements are provided. In one embodiment, a test element having dual functionality includes a first coenzyme-dependent enzyme or a substrate for the first enzyme, a second coenzyme-dependent enzyme or a substrate for the second enzyme, and a coenzyme selected from the group consisting of thio-NAD, thio-NADP, and a compound according to formula (I). In one aspect, the first analyte is hydroxybutyrate and the first enzyme is a hydroxybutyrate dehydrogenase, and the second analyte is glucose and the second enzyme is a glucose dehydrogenase or a glucose oxidase. Other aspects of the subject application are directed to unique reagent materials. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract: Methods for diagnosing and treating cancer associated with an oncogenic Kras mutation in a subject are provided.

Abstract: A method is disclosed for determining the hypoglycemic potential of Momordica charantia (bitter melon) extracts through an in vitro test representative of the range of serum blood sugar typical of normal and diabetic subjects.

Abstract: The present invention relates to glucose dehydrogenase [NAD(P)+GDH] using nicotinamide adenine dinucleotide or nicotinamide adenine dinucleotide phosphate as a coenzyme, in which the thermal stability and/or the resistance to an organic solvent in the absence of sodium chloride are improved.

Abstract: This invention provides an amadoriase having high reactivity with ?-fructosyl hexapeptide (?F6P) derived from the ?-chain amino terminus of glycated hemoglobin (HbAlc), which enables satisfactory quantification of ?F6P cleaved from HbAlc. A novel amadoriase is derived from the amadoriase of the genus Coniochaeta by substitution of one or more amino acids at positions selected from the group consisting of positions 62, 63, 102, 106, 110, 113, 355, and 419. Such amadoriase enables rapid, simple, accurate, and satisfactory quantification of ?F6P cleaved from HbAlc. With the use of such amadoriase, a method for measurement of HbAlc by an enzymatic method and a kit for measurement of HbAlc that are based on the same principle as used in the conventional standard method and excellent in terms of the relevance with the standard method.

Abstract: A portable, hand-held glucose testing device includes a housing configured to accommodate a plurality of test sensors in a stacked arrangement and having a wall with an opening defined therein. A plurality of packaged test sensors is stacked in alignment with one another within the housing. Each of the test sensors is packaged within a blister package. The blister package includes a blister package housing and a cover foil overlying a surface of the blister package housing and the test sensor. A drive slide is configured to displace one of the plurality of packaged test sensors out of alignment with other packaged test sensors. A knife mechanism is configured to pierce through the cover foil, and to engage and urge the test sensor to extend through the opening for receiving a sample. A meter contact is configured to engage the test sensor when the test sensor extends through the opening.

Abstract: A method for detecting at least one analyte in at least one sample of a body fluid is disclosed. Therein, at least one test element (124) is used, the at least one test element (124) having at least one test field (162) with at least one test chemistry (154) is used, wherein the test chemistry (154) is adapted to perform at least one optically detectable detection reaction in the presence of the analyte. The method comprises acquiring an image sequence of images of the test field (162) by using at least one image detector (178). Each image comprises a plurality of pixels. The method further comprises detecting at least one characteristic feature of the test field (162) in the images of the image sequence. The method further comprises correcting a relative position change between the image detector (178) and the test field (162) in the image sequence by using the characteristic feature, thereby obtaining a sequence of corrected images.

Abstract: An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Abstract: The invention is directed to an assay for acid ?-galactosidase activity. The invention may include combining in oil a sample droplet with a 4-methylumbelliferyl-B-galactose to yield a reaction droplet; splitting the reaction droplet to yield a first daughter droplet and a second daughter droplet; combining the first daughter droplet with a stop buffer droplet to yield a first stopped reaction droplet; incubating the second daughter droplet; combining the second daughter droplet with a stop buffer droplet to yield a second stopped reaction droplet; and measuring 4-methylumbelliferone released in the first and second stopped reaction droplets.