The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.

Device and methods for use in a biosensor comprising a multisite array of test sites, the device and methods being useful for modulating the binding interactions between a (biomolecular) probe or detection agent and an analyte of interest from a biological by modulating the pH or ionic gradient near the electrodes in such biosensor. An electrochemically active agent that is suitable for use in biological buffers for changing the pH of the biological buffers. Method for changing the pH of biological buffers using the electrochemically active agents. The methods of modulating the binding interactions provided in a biosensor, analytic methods for more accurately controlling and measuring the pH or ionic gradient near the electrodes in such biosensor, and analytic methods for more accurately measuring an analyte of interest in a biological sample.

A hand-held test meter for use with an electrochemical-based analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing, a micro-controller disposed in the housing, a test strip simulation passive circuit block disposed in the housing, and a strip port connector (“SPC”) configured to operationally receive an electrochemical-based analytical test. The test strip simulation passive circuit block is in electrical communication with the SPC and the SPC is configured in electrical communication with the micro-controller. In addition, the test strip simulation passive circuit block is configured to simulate insertion of an electrochemical-based analytical test strip into the SPC and also to simulate application of a bodily fluid sample to an electrochemical-based analytical test strip inserted into the SPC by presenting one or both of (i) an alternating current (AC) load to SPC; and (ii) a direct current (DC) load to the SPC.

A test element for electrochemically detecting at least one analyte in a bodily fluid is disclosed. The test element comprises at least one first electrode and at least one second electrode. The first electrode is designed as a working electrode and the second electrode is designed as a counter electrode. The test element comprises at least one capillary capable of receiving a sample of the body fluid. The first electrode and the second electrode are arranged on opposing sides of the capillary. The first electrode and the second electrode are arranged such that during a capillary filling the first electrode and the second electrode are wetted simultaneously and at an equal rate.

Disclosed herein are compositions comprising oxygen, a sugar or sugar alcohol, and an amino acid, wherein the amino acid is present in an amount sufficient to stabilize the oxygen. Also provided are aqueous diagnostic quality controls or calibration reagents and methods of stabilizing oxygen in a liquid solution.

A method of calibrating a device for measuring the concentration of creatinine in a sample including one or more enzyme modulators, the method comprising: determining sensitivities of the device for each of two or more calibration solutions, wherein each calibration solution has a different amount of enzyme modulator; determining a degree of modulation for each of the two or more calibration solutions; determining a degree of modulation for a sample to be measured; and calculating the sensitivity of the device for the sample, wherein said calculating comprises modifying the sensitivity of one of the two or more calibration solutions by a function comprising the determined degrees of modulation.

Methods are provided for correcting an analyte concentration measurement that may be influenced by hematocrit (HCT), especially a glucose concentration measurement. The methods include determining by means of a reference instrument a HCT reference value of a reference blood sample taken from a specific user, applying a fresh blood sample of the user on a disposable analytical test element, measuring the glucose value of the fresh blood sample by single use of the test element in a glucose meter, determining a HCT correction value using at least the HCT reference value, and adjusting the measured glucose value using the HCT correction value to receive an adjusted glucose value. Also provided are devices and system incorporating or for performing the methods.

Pre-connected analyte sensors are provided. A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured for mechanical coupling of the sensor to testing, calibration, or wearable equipment. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the testing, calibration, or wearable equipment.

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain a single, fused SG value.

A method for determining a concentration of an analyte in a fluidic sample is described. A sample is applied to a biosensor including an electrochemical cell having electrodes. A predetermined voltage waveform is applied during at least first and second time intervals. At least first and second current values are measured during the first and second time intervals, respectively. A turning point time is determined during the first time interval at which the measured first current values transition from a first to a second profile. The concentration of analyte in the sample is calculated based on determined turning point time and at least one measured current value. In another example, a physical characteristic of the sample is estimated based on measured current values. The concentration is calculated using a first or second model if the estimated physical characteristic of the sample is in a first or second range, respectively.