The present disclosure provides an electrode substrate including an insulating substrate having, on a surface thereof, a region where at least one fine uneven structure is formed and a plurality of smooth regions separated by the fine uneven structure; and a conductive thin film formed on the entire of at least one surface of the insulating substrate where the fine uneven structure is formed. According to the present disclosure, the conductive region and the insulating region can be simultaneously formed on the insulating substrate only by forming the conductive thin film in a single step on the entire surface of the single insulating substrate on which the fine uneven structure is formed.

The present disclosure provides apparatuses and methods for analyzing the presence of a target analyte. The apparatuses and methods of the present disclosure can be operated in a multiplexed format to perform various assays of clinical significance.

Methods and biosensor systems for compensating an analyte measurement are provided. The methods and systems determine a secondary output signal based on the measured primary output signal in order to better approximate the effects of an extraneous stimulus on the primary output signal under actual measurement conditions. The methods and systems according to the present disclosure may provide a more accurate analyte measurement, and may be particularly useful in detecting and compensating an analyte measurement during an off-condition.

The electrolyte analysis test strip of the present invention includes a substrate extending in one direction. A first ion-sensitive film provided in a specific region on the one end side in the one direction and a first extraction electrode extending from the first ion-sensitive film to the other end side are provided on one main surface of the substrate. A second ion-sensitive film provided in a specific region on the one end side and a second extraction electrode extending from the second ion-sensitive film to the other end side are provided on the other main surface of the substrate. The first ion-sensitive film and the second ion-sensitive film each come into contact with an electrolyte to generate a first potential corresponding to a concentration of a first ion species and a second potential corresponding to a concentration of a second ion species, respectively.

A transistor device (10) is disclosed comprising a source electrode (14) a drain electrode (12) and an enzyme (31) for facilitating generation of a charge carrier from an analyte. The transistor device also comprises a polymer layer (30) for retaining the enzyme (31), the polymer layer (30) being conductive to the charge carrier. The device also comprises an ohmic conductor (32) in contact with said polymer layer (30) for applying a gate voltage to said polymer layer (30). The device also comprises an organic semiconducting layer (18) connecting the source electrode (14) to the drain electrode (12). Also disclosed is a method of making and using the device (10).

A method for configuring a device to determine a concentration of an analyte uses a plurality of m fluid samples, each having a corresponding known analyte concentration. The method includes, for each sample: generating an output signal from the sample; recording values of the signal over time; and modelling a subset of the values of the signal using n basis functions to obtain n coefficients. Each coefficient is associated with a corresponding basis function, the n basis functions and n coefficients representing the signal for the subset. The method also includes performing a statistical analysis of the m×n coefficients and corresponding known analyte concentrations to determine a set of n parameters from which an analyte concentration can be estimated based on a set of n coefficients obtained for a sample for which the analyte concentration is unknown; and storing the set of n parameters in a memory of a device.

A method is provided for determining analyte concentrations, for example glucose concentrations, that utilizes a dynamic determination of the appropriate time for making a glucose measurement, for example when a current versus time curve substantially conforms to a Cottrell decay, or when the current is established in a plateau region. Dynamic determination of the time to take the measurement allows each strip to operate in the shortest appropriate time frame, thereby avoiding using an average measurement time that may be longer than necessary for some strips and too short for others.

Biosensor systems including a measurement device and test sensors including at least three independently addressable electrodes, with at least two of the electrodes being substantially chemically isolated are disclosed. One or more working electrodes may be combined with two or more counter electrodes. The two or more counter electrodes may operate at different potentials to provide for multi-analyte electrochemical analysis. Analysis methods are provided to perform multi-analyte electrochemical analysis and test sensors are provided having resistance to chemical mixing between secondary analysis regions.

Provided are an amadoriase that is less likely to be influenced by oxygen concentration and a method and a reagent kit for measurement of HbA1c using such amadoriase. Provided are an amadoriase that is obtained via substitution of one or more amino acid residues at a position or positions corresponding to the position(s) selected from the group consisting of positions 280, 267, 269, 54, and 241 of the amadoriase derived from the genus Coniochaeta, a method for measurement of HbA1c, a reagent kit for measurement, and a sensor using such amadoriase. The modified amadoriase according to the invention has a lowered oxidase activity and an enhanced dehydrogenase activity, and this enables the use of an electron mediator, and this reduces the influence of oxygen concentration. Thus, HbA1c can be measured with high sensitivity.

Apparatus and methods for determining the blood glucose concentration of a patient are disclosed A saliva glucose measurement strip is used in conjunction with a glucose measurement device to measure an electrochemical signal of a saliva sample and the measured electrochemical signal is correlated to a blood glucose convention.