Biosensor system measurement devices used to determine the presence and/or concentration of an analyte in a sample include normalized calibration information relating output signal or signals the device generates in response to the analyte concentration of the sample to previously determined reference sample analyte concentrations. The measurement devices use this normalized calibration information to relate one or more output signals from an electrochemical or optical analysis of a sample to the presence and/or concentration of one or more analytes in the sample. The normalized calibration information includes a normalization relationship to normalize output signals measured by the measurement device of the biosensor system and at least one normalized reference correlation relating normalized output signals to reference sample analyte concentrations.

The present invention provides a protein comprising an amino acid sequence in which arginine at position 61 of a protein comprising the amino acid sequence represented by SEQ ID NO: 1 is substituted to an amino acid selected from the group consisting of glycine, alanine, valine, leucine, serine, threonine, proline, cysteine, methionine, asparagine, glutamine, and aspartic acid; and a method for measuring a glycated hemoglobin in a sample, wherein the method comprises reacting a glycated hemoglobin in a sample with a protease to produce a glycated hexapeptide, then reacting the produced glycated hexapeptide with the aforementioned protein, and measuring a substance produced or consumed by the reaction.

A hemoglobin advanced glycation end products measuring instrument includes a measuring base, a measuring container, a light emitting unit, a first photosensitive assembly, a second photosensitive assembly, and a processor. The light emitting unit outputs parallel light beam when being driven. The parallel light beam irradiates to-be-tested liquid in the measuring container to generate fluorescence and a transmission light beam. The first photosensitive assembly is positioned at the first optical axis, and receiving and converting the transmission light beam with a first preset wavelength into first light intensity. The second photosensitive assembly is positioned at the second optical axis, and receiving and converting the fluorescence with a second preset wavelength into a second light intensity. The processor obtains a hemoglobin advanced glycation end products measuring result according to the first light intensity, the second light intensity, the first standard intensity and the first empty intensity.

Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (k.sub.gly), a red blood cell generation rate constant (k.sub.gen), a red blood cell elimination constant (k.sub.age), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.

Error may be introduced into an analysis by both the biosensor system used to perform the analysis and by errors in the output signal measured by the measurement device of the biosensor. For a reference sample, system error may be determined through the determination of relative error. However, during an analysis of a test sample with the measurement device of the biosensor system, true relative error cannot be known. A pseudo-reference concentration determined during the analysis may be used as a substitute for true relative error. The closer the analysis-determined pseudo-reference analyte concentration is to the reference analyte concentration of the test sample, the more accurate and/or precise the analyte concentration determined by the measurement device using an anchor parameter during compensation. The present invention provides an improvement in the accuracy and/or precision of the analysis determined pseudo-reference concentration through progressive approximation.

High affinity DNA aptamers Seq ID#1-8 for HbA1C and tHb were successfully selected using SELEX after 11 rounds of selection. The tested aptamers bind to HbA1C with dissociation constants in the nanomolar range with the highest affinity aptamer, Seq ID#6, exhibiting a K.sub.d of 2.8 nM. Another aptamer sequence (Seq ID #4) which showed high binding affinity to tHb with a K.sub.d of 2.7 nM was also selected. The HbA1C and tHb-specific aptamers were then applied for the detection of HbA1C % using a voltammetric aptasensor array platform showing remarkable sensitivity and selectivity. The aptasensor array platform was validated using standard human whole blood samples and demonstrated linearity over wide concentration range. The developed platform is superior to current methodologies due to its simplicity, stability and lower cost which will facilitate the early and accurate diagnosis of diabetes.

High affinity DNA aptamers Seq ID#1-8 for HbA1C and tHb were successfully selected using SELEX after 11 rounds of selection. The tested aptamers bind to HbA1C with dissociation constants in the nanomolar range with the highest affinity aptamer, Seq ID#6, exhibiting a K.sub.d of 2.8 nM. Another aptamer sequence (Seq ID #4) which showed high binding affinity to tHb with a K.sub.d of 2.7 nM was also selected. The HbA1C and tHb-specific aptamers were then applied for the detection of HbA1C % using a voltammetric aptasensor array platform showing remarkable sensitivity and selectivity. The aptasensor array platform was validated using standard human whole blood samples and demonstrated linearity over wide concentration range. The developed platform is superior to current methodologies due to its simplicity, stability and lower cost which will facilitate the early and accurate diagnosis of diabetes.

A method includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. A first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. A second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties. Also provided are systems and components useful in performing the disclosed methods.

A novel method of predicting life expectancy in persons, in particular in persons that have an a priori reduced life expectancy, for instance if they suffer from ischemic heart disease (IHD). IHD-related depression, ANSD, type 2 diabetes mellitus is provided. Also disclosed is a related method for increasing life expectancy in human subjects, in particular in human subjects having an a priori reduced life expectancy. The disclosure also provides a method for evaluating the efficacy of drugs other treatment of ANSD. The present invention also provides a novel method for diagnosing and treating/preventing type 2 diabetes mellitus or IHD-related depression. Finally, the disclosure also provides a method for diagnosing autonomic homeostatic glucose dysregulation, and a novel method to re-establish normal homeostatic function, if disrupted, dysregulated or insufficient.

The present invention relates to, in part, methods of improved healthcare in female subjects that, for example, rely on menstrual fluid sampling for applying selection biomarkers.