Abstract: Methods are provided for making rapid labeled dextran ladders and other calibrants useful in liquid chromatography. The methodologies include a two-step process comprising a reductive amination step of providing a reducing glycan and reacting it with a compound having a primary amine to produce an intermediate compound. The intermediate compound is then rapidly tagged with a rapid tagging reagent to produce the rapid labeled dextran ladder.

Abstract: A glucose meter with an adjustable alarm and an integral wireless transmitter to send a user a reminder to take a second glucose level measurement. The glucose meter with an alarm features a housing with a display and input buttons connected to a microprocessor. The housing has a slot designed to accept a strip with a sample of blood. A glucose level sensor within the housing is adapted to measure the glucose level of the blood sample. After the measurement is taken, an alarm is set to activate after a predetermined period of the time, reminding a user to take a second glucose level measurement. The alarm can be an auditory or a vibrating alarm. Additionally, the wireless transmitter is designed to send an email or text message to a user as a reminder to take a second glucose level measurement.

Abstract: An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

Abstract: An analyzing and reading device and an analyzing and reading method, for reading and analyzing a test strip for assay detection are disclosed. The test strip has a detection zone and a blank zone, the device includes a photoelectric detection circuit and a processor, wherein the photoelectric detection circuit includes at least two light sources which locate corresponding to the positions of the detection zone and the blank zone of the test strip and are able to emit lights corresponding to the detection zone and blank zone of the test strip, and at least one optical detectors which receive reflected lights from the above two zones; wherein lights emitted by the at least two light sources irradiate the detection zone and blank zone of the strip and are reflected therefrom, and then are received by the optical detector, which in turn feedback the detection information to the processor; the processor making analysis and decision based on the detection information received.

Abstract: There is provided a test method for analysing a body fluid in which a test tape is used in a test device in order to successively provide analytical test fields stored on the test tape, wherein body fluid is applied by a user to the test field provided at a time and the said test field is photometrically scanned using a measuring unit of the device to record measurement signals. In order to increase the measurement reliability, it is proposed that a control value is determined from a time-dependent and/or wavelength-dependent change in the measurement signals and that the measurement signals are processed as valid or discarded as erroneous depending on the control value.

Abstract: Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.

Abstract: A biosensor calibration method configured to measure a concentration of a specific substance contained in sample liquid to be measured, including: a first step configured to acquire a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor; a second step configured to acquire a second output value that is output by the biosensor when second calibration liquid having a different concentration from that of the first calibration liquid is continuously brought into contact with the biosensor after the first step and determine time for replacement of the biosensor on the basis of the first output value and the second output value.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: Testing of the performance of an electrochemical meter used to measure the presence of an analyte in a biological sample, particularly glucose in whole blood, includes introducing a control solution containing a predetermined amount of the analyte and a predetermined amount of an internal reference compound. The internal reference compound is selected such that it is oxidized at a potential greater than that used to oxidize the analyte, thereby making it possible to distinguish the control solution from a biological sample.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: A portable apparatus for measuring a glucose level of a user having: a card-like member; a processor within the card-like member; at least one glucose sensor comprising a reagent, the glucose sensor generating a signal indicative of a measured glucose level upon application of a blood sample to the glucose sensor, wherein the glucose sensor is fixed to the card-like member and operably coupled to the processor; and at least one cover alterable between a first position in which the glucose sensor is covered and a second position in which the glucose sensor is exposed for use.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: The invention is composition comprising red blood cells in an aqueous suspension medium and one or more cis di-ahls; wherein more than 6 percent by weight of the hemoglobin in the red blood cells is S-Alc glycated hemoglobin. In another embodiment, the invention is a method comprising contacting red blood cells in a suspension medium having a concentration of S-Alc glycated hemoglobin of greater than 6 percent by weight of the hemoglobin in the red blood cells with a sufficient amount of one or more cis di-ahls such that the concentration of S-Alc glycated hemoglobin in resulting composition as measured by high pressure liquid chromatography, immunoassay and boronate affinity methods is consistent.

Abstract: By way of summary, the present invention meets some or all of the above needs by providing in a first aspect a method comprising contacting red blood cells in a suspension medium containing mannose under conditions such that the concentration of S-Alc glycated hemoglobin is increased to greater than about 6 percent by weight of the hemoglobin in the red blood cells. Preferably the suspension medium is an aqueous suspension medium. In preferred embodiments, the method is performed at about ambient temperature, 18° C. to about 23° C.

Abstract: A biosensor container comprising a housing defining an internal glucose test strip compartment. The housing has an engagement portion for retaining a detachable means for storing data, and the means for storing data has data stored thereon specific to a batch of glucose test strips. At least one of the housing and the means for storing data includes at least one data reading element that is externally accessible when the means for storing data is retained by the engagement portion of the housing. The container includes various fail safe features to prevent mishandling and insure the user obtains the correct results. The housing includes means for connecting to the bG meter only when the means for storing data is retained by the housing. The housing further includes means for dispensing glucose test strips only when the housing is in either of an attached-to meter mode or a stand-alone mode.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: Methods and systems for preparation of calibrant infusion fluid sources are disclosed. In one embodiment, a precise volume of glucose is injected into a saline-solution filled calibrant infusion fluid source proximate in time to conducting a calibration procedure. The glucose concentration in the calibrant infusion fluid source is subsequently calculated based on the measured weight of the saline-solution, as determined prior to glucose injection, and the volume of glucose injected. This method provides a highly accurate and convenient manner for use in a hospital environment, for example, with an intravenous blood glucose sensor system. In another embodiment, a premixed calibrant infusion fluid source is provided that includes saline solution and a predetermined concentration of glucose. In such embodiments, shelf life problems related to water evaporation are mitigated by hermetically covering or otherwise hermetically containing the calibrant infusion fluid source up until the point of use.

Abstract: A reagent for detecting an analyte by a redox reaction and a fluorimetric determination is disclosed. The reagent comprises a compound of formula (I): wherein R1 and R2 are each independently selected from R, (CH2CH2O)mR, COR, COOR, and OCOR; each R3 is independently selected from NO2, CN, R, OR, OCOR, COOR, SR, and halogen; R is H or C1-C4 alkyl, where alkyl is optionally substituted with one or more functional group independently selected from the group consisting of halogen, OR, SR, NR2, COOR, CONR2, SO3R and salts thereof, and PO(OR)3 and salts thereof; m is an integer from 1 to 20; and n is 1, 2, or 3. The reagent may further comprise an enzyme or a coenzyme for reducing or oxidizing an analyte.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: A biodevice is in an elongated form and has a conductive layer and an insulating layer stacked on a side surface of a shaft member at the center. A cylindrical hollow section is formed through the device, being connected to the exterior at a front end and extending from this front end axially. An electrode section is formed on an inner surface. A sensing substance such as enzyme may be placed at the electrode section to detect a current value corresponding to the concentration or quantity of an object under test placed between a counter electrode and the biodevice.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase, and peroxidase. The invention provides kits for performing the methods of the invention.

Abstract: An integrated meter system for determining information related to an analyte of a fluid sample includes a meter including a housing and a plurality of test sensors. Each of the plurality of test sensors includes a penetrating member, a testing portion, and a channel. The channel is adapted to receive the fluid sample. The test sensors are removably located within the housing. At least one of the test sensors is removably connected to an adjacent test sensor. The integrated meter system also includes a test-sensor advancement mechanism that is configured to advance the test sensors.

Abstract: Novel pyridinium salts functionalized with boronic acid and methods of making them are disclosed. When combined with a fluorescent dye, the compounds are useful in the detection of polyhydroxyl-substituted organic molecules.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: The invention relates to a method for investigating the glucose metabolism of a human being for disease-relevant and/or disease-related particularities. The glucose concentration g(t1) to g(tn) of a body fluid is measured at time points t1 to tn that are distributed over a period of at least six hours. The data points are then determined in phase space coordinates from the glucose concentration measuring values g(t1) to g(tn). The data points are then processed to highlight disease-relevant and/or disease-related particularities of the glucose metabolism of the investigated human being. The processing of the data points can be implemented by plotting them in a phase space representation or by determining from the data points a disturbance parameter that is correlated to the severity of a disturbance of glucose metabolism.

Abstract: Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter's user. Methods for use of the solutions are also provided.

Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: A test system comprises a sensor container and a testing device. The sensor container has a base and a lid. The container encloses test sensors therein. The container includes a calibration label attached thereto. The label includes electrical contacts located thereon. The electrical contacts encode calibration information onto the calibration label. The testing device has an auto-calibration feature externally located thereon. The testing device is adapted to determine the analyte concentration in a fluid sample. The auto-calibration feature includes calibration elements that communicate with the electrical contacts on the calibration label. The testing device is adapted to determine the calibration information encoded on the calibration label in response to the calibration elements engaging the electrical contacts. The encoded calibration information is determined without inserting the sensor container or the calibration label into the testing device.

Abstract: A method for manufacturing chip stack packages may include: providing at least two wafers, each wafer having a plurality of chips, and scribe lanes formed between and separating adjacent chips; forming a plurality of via holes in peripheral portions of the scribe lanes; forming connection vias by filling the via holes; establishing electrical connections between the chip pads and corresponding connection vias; removing material from the back sides of the wafers to form thinned wafers; separating the thinned wafers into individual chips by removing a central portion of each scribe lane; attaching a first plurality of individual chips to a test wafer; attaching a second plurality of individual chips to the first plurality of individual chips to form a plurality of chip stack structures; encapsulating the plurality of chip stack structures; and separating the plurality of chip stack structures to form individual chip stack packages.

Abstract: A container with a rotatable lid for reading and handling diagnostic reagents in tape form comprising a body portion, a lid portion, a continuous tape, a reagent-sensing device, and a storage device. The body portion includes an inner and outer surface. The lid portion is attached to the body portion and is adapted to rotate from a closed position to an open position. The continuous tape includes a diagnostic reagent. The reagent-sensing device is attached to either the body portion or the lid portion and adapted to read the diagnostic reagent. The storage device is attached to the body portion that is adapted to hold and dispense an unused portion of the continuous tape. During the rotation of the lid portion, the continuous tape is advanced from the first storage device and is extended over the reagent-sensing device.

Abstract: A method of sensing glucose in subjects includes the steps of providing a sensing solution including a plurality of metal ions, introducing a bodily fluid sample from a subject into the sensing solution. An optically-based measurable derived from directing incident light on the solution is generated. The concentration of glucose in the bodily fluid using the measurable is then determined which permits the blood glucose level to be derived.

Abstract: The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: An object of the present invention is to quantitate with good accuracy, furthermore, quantitate absolutely, one or a plurality of biological molecules in a sample such as a tissue, a biological fluid, a cell, a cell organ or protein complex. By adding a metabolically isotope labeled biological molecule as an internal standard substance and measuring with a mass spectrometer, quantitating with good accuracy one or a plurality of target molecules in a sample has become possible. In addition, by performing waveform separation processing during mass analysis, a highly accurate quantitative analysis method of mass analysis is provided.

Abstract: The invention concerns a method for automatically differentiating between a sample liquid and a control liquid especially within the context of analytical measuring systems, wherein the presence of a special property of the control liquid and/or at least two criteria are used for the differentiation. In addition the invention concerns appropriate control liquids that are suitable for the new method.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: A urine analysis system includes a urinary particle analyzer and a computer. The urinary particle analyzer has a measuring unit that measures a cast concentration from the urine and an electric conductivity sensor that measures the electric conductivity of the urine. The computer has a function of correcting the cast concentration measured by the measuring unit on the basis of the electric conductivity of the urine measured by the electric conductivity sensor and a function of outputting the corrected cast concentration.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: A process of concentration by precipitation of PrPsc for detecting or diagnosing PrPsc, wherein a tissue or biological fluid stemming from or obtained from an animal or human organism is brought together with an antibiotic from the family of aminoglycosides, preferably streptomycin or one of its derivatives. The use of such an antibiotic for eliminating PrPsc from a tissue or biological fluid and a kit for diagnosing pathologies associated with the presence of PrPsc is also disclosed.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: A method of evaluating the presence or absence and/or degree of metal contamination of a semiconductor substrate including etching the surface of the semiconductor substrate by SC-1 cleaning and/or a HF cleaning, detecting bright points on the surface of the etched substrate with a foreign matter inspection device, and evaluating the presence or absence and/or degree of metal contamination of the semiconductor substrate based on the distribution pattern of bright points detected on the surface of the substrate. Also disclosed is a method of manufacturing a semiconductor substrate comprising mirror polishing a silicon wafer surface, wherein the mirror polishing is conducted using a slurry having a Cu content of approximately equal to or less than 10 ppb, a Ni content of approximately equal to or less than 10 ppb, and an Fe content of approximately equal to or less than 1,000 ppb, and evaluating the semiconductor substrate as above.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: The present invention is directed toward a stable calibrator and/or control, kit and process for using in a glucose monitoring instrumentation. Principally, the instant invention teaches a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound which may be added to fresh plasma along with an amount of glucose to form a simulated whole blood glucose control product, effective for maintaining a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).