Analysis system for the photometric determination of an analyte in a body fluid
First Claim
1. An analysis system for the photometric determination of an analyte in a body fluid, the system comprising an analysis instrument and a test carrier, the test carrier comprising an evaluation zone in which a photometrically detectable change occurs as a result of a reaction of a sample of the body fluid contacted to the test carrier with a reagent contained in the test carrier, the analysis instrument comprising:
- an optical emitter for emitting light onto the evaluation zone of the test carrier;
an optical receiver for receiving light from the evaluation zone and for generating a measurement signal corresponding to the received light;
a measuring and evaluation device having a measuring unit and an evaluation unit, whereinthe measuring unit is capable and adapted for amplifying and digitizing the measurement signal generated by the receiver,the evaluation unit is capable and adapted for determining the desired concentration value from the digitized measurement signal using an evaluation algorithm, which comprises a production-method-specific assignment of concentration values to the values of the digitized measurement signal, wherein in the evaluation algorithm at least one computing step is executed by means of a processor,the evaluation unit is capable and adapted for acquiring in the algorithmic sequence of steps the concentration value at an acquisition point downstream from the execution of the computing step,and wherein the concentration value is verified by means of a control algorithm by determining a deviation of the determined concentration value from a reference concentration value, the reference concentration value being determined from a reference measurement value using reference assignment data in the control algorithm, the reference assignment data assigning a plurality of reference concentration values to a plurality of reference measurement values,and wherein the analysis system is capable and adapted for recognizing an error of the measuring and evaluation device if the deviation of the concentration value from the reference concentration value exceeds a predefined limiting value.
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Accused Products
Abstract
The invention relates to an analysis system for the photometric determination of an analyte in a body fluid, having an analysis device and a test carrier. The test carrier has an evaluation zone in which a photometrically detectable change takes place as the result of a reaction of a sample of the body fluid which contacts the test carrier with a reagent contained in the test carrier. The analysis device comprises an optical emitter for emitting light onto the evaluation zone, an optical receiver for receiving light from the evaluation zone and for generating a measurement signal corresponding to the received light, and a measurement and evaluation device with a measuring unit and an evaluating unit. The measurement signal is amplified and digitalized in the measuring unit. In the evaluating unit, the concentration value is determined from the digitalized measurement signal. In the evaluating unit, a control value of a control parameter is detected at one detection point during the processing after the calculation step. An error in the measurement and evaluation device is recognized if the deviation of the control value from the expected value exceeds a predefined threshold value.
5 Citations
16 Claims
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1. An analysis system for the photometric determination of an analyte in a body fluid, the system comprising an analysis instrument and a test carrier, the test carrier comprising an evaluation zone in which a photometrically detectable change occurs as a result of a reaction of a sample of the body fluid contacted to the test carrier with a reagent contained in the test carrier, the analysis instrument comprising:
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an optical emitter for emitting light onto the evaluation zone of the test carrier; an optical receiver for receiving light from the evaluation zone and for generating a measurement signal corresponding to the received light; a measuring and evaluation device having a measuring unit and an evaluation unit, wherein the measuring unit is capable and adapted for amplifying and digitizing the measurement signal generated by the receiver, the evaluation unit is capable and adapted for determining the desired concentration value from the digitized measurement signal using an evaluation algorithm, which comprises a production-method-specific assignment of concentration values to the values of the digitized measurement signal, wherein in the evaluation algorithm at least one computing step is executed by means of a processor, the evaluation unit is capable and adapted for acquiring in the algorithmic sequence of steps the concentration value at an acquisition point downstream from the execution of the computing step, and wherein the concentration value is verified by means of a control algorithm by determining a deviation of the determined concentration value from a reference concentration value, the reference concentration value being determined from a reference measurement value using reference assignment data in the control algorithm, the reference assignment data assigning a plurality of reference concentration values to a plurality of reference measurement values, and wherein the analysis system is capable and adapted for recognizing an error of the measuring and evaluation device if the deviation of the concentration value from the reference concentration value exceeds a predefined limiting value. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for the photometric determination of an analyte in a body fluid using an analysis system comprising an analysis instrument and a test carrier, the test carrier having an evaluation zone, in which a photometrically detectable change occurs as a result of a reaction of a sample of the body fluid contacted with the test carrier with a reagent contained in the test carrier, and the analysis instrument comprising an optical emitter for emitting light, an optical receiver for receiving light, a measuring and evaluation device having a measuring unit and an evaluation unit, the method comprising the following steps:
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a) emitting light from the emitter onto the evaluation zone of the test carrier; b) receiving light from the evaluation zone; c) generating a measurement signal corresponding to the received light; d) amplifying and digitizing in the measuring unit the measurement signal generated by the receiver; e) determining in the analysis unit the desired concentration value from the digitized measurement signal using an evaluation algorithm which comprises an assignment between values of the digitized measurement signal and concentration values, the assignment being specific to the production method, at least one computing step being executed by a processor in the evaluation algorithm, f) acquiring the concentration value in the evaluation unit at an acquisition point in the algorithmic sequence of steps downstream from the execution of the computing step; g) verifying the concentration value using a control algorithm by g1) assigning a plurality of reference measurement values to a plurality of reference concentration values using a reference assignment; g2) determining the reference concentration value using the reference assignment from a reference measurement value; g3) using the reference assignment in the control algorithm; and g4) determining a deviation of the determined concentration value from the reference concentration value using the reference assignment; and h) recognizing an error of the measuring and evaluation device if the deviation of the concentration value from the reference concentration value exceeds a predefined limiting value. - View Dependent Claims (12, 13, 14, 15, 16)
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Specification