Method for calibrating a device for measuring the concentration of a biological compound

Abstract

It is disclosed a method for calibrating an electronic device for measuring the concentration of a biological compound, in particular bilirubin. The method comprises the step a) of performing (10) a plurality of reflectance measurements for each reference strip of a plurality of reference strips (110-1, 110-2,... 110-8) having respective predefined concentration values of the biological compound,the step b) of calculating (20), for each reference strip, a respective value of a statistical reflectance indicator as a function of the plurality of reflectance measurements, generating a pluralityof values of the statistical reflectance indicator, the step c) of subdividing the plurality of values of the statistical reflectance indicator into at least two subsets (I, II, III), the step d) of interpolating (41 ) the values of the statistical reflectance indicator of each subset so as to generate an interpolation curve for each subset, the step e) of calculating (43), for each pair of interpolation curves relative to two adjacent subsets (I, II), a reflectance threshold value for which the difference of the reflectance values of the pair of interpolation curves is minimum, the step f) ofselecting, for each interpolation curve, a portion delimited at least in part by the respective reflectance threshold values, said portion being associated with the respective plurality of values ofthe statistical reference indicator, and the step g) of generating (50) a calibration curve of the electronic device by combining the selected portions of the interpolation curves.

Description

technical field [0001] The invention relates to the field of medical equipment. [0002] In particular, the invention relates to a method for calibrating a device for measuring the concentration of bilirubin in blood. Background technique [0003] Bilirubin is a molecule produced by the catabolic process of hemoglobin, primarily caused by the destruction of aging red blood cells. [0004] The high antioxidant activity of bilirubin has led to the hypothesis that this molecule primarily exerts cellular antioxidant functions. [0005] However, in cases of excessive hemoglobin degradation or malfunction in the processing mechanism, bilirubin can accumulate in the blood causing jaundice and subsequent deposition in tissues. In fact, the yellow coloration of the skin, sclera and mucous membranes highlights the increased concentration of bilirubin in the blood. [0006] Jaundice is common in newborns and occurs because after birth the newborn starts using red blood cells contain...

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Problems solved by technology

[0018] In particular, WO2012 / 038930 discloses a method for determining a calibration curve which has the disadvantage of being inaccurate as the value of the bilirubin concentration to be measured increases: in this way, for hyperbilirubin levels, which are those of most interest since they are used to determine whether a therapy requires a prescription, are less accurate and therefore increase the risk of obtaining incorrect and unreliable concentration measurements

The reason for this unreliability is that the reference strips described for obtaining the calibration curve do not guarantee reproducibility during industrial production, which has a direct impact on the final calibration accuracy of the measuring equipment

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