Test carrier analysis system

• US 5,413,764 A
• Filed: 04/03/1990
• Issued: 05/09/1995
• Est. Priority Date: 04/08/1989
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH FED REP of Germany
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Haar, Hans-Peter
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/503,585
• Time in Patent Office: 1,862 Days
• Field of Search: 436/169, 436/170, 422/55-60, 422/82.05-82.09, 422/61, 422/68.1, 422/82.01, 422/82.02, 435/4, 204/403, 364/413.08, 364/413.11, 364/497, 364/551.01
• US Class Current: 422/82.09
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/521 Single-layer analytical elements

Abstract

A test carrier analysis system for analyzing a body fluid, the system including a test carrier (1) with a detection layer (20) on which a detectable change specific to the analysis takes place, obeying an evaluation curve, to the concentration of the component, and wherein the evaluation curve is dependent on the manufacturing batch of the test carrier. The system further includes an evaluator having a measuring and digitization circuit (25) which generates from the physically detectable change an intermediate result independent of the evaluation curve in the form of a finite number of digital output states, and having a display (7) for indicating the output states in the form of an alpha and/or numeric code. A readable information carrier element is provided having a correlation thereon between the alphanumeric codes of the display (7) corresponding to the output states and the concentration values determined in accordance with the evaluation curve.

Claims

1. A test carrier analysis system for analyzing a component of a fluid sample comprising:

a plurality of test carriers containing at least one reagent in at least one test layer thereof, in which a reaction of the at least one reagent with a component to be analyzed leads to a detectable change in at least one of said test layers, wherein the detectable change follows a particular relationship, obeying an evaluation curve wherein a parameter of the fluid sample corresponds to the detectable change of the concentration of the component, and wherein the evaluation curve is dependent on a manufacturing batch of the plurality of test carriers;

evaluation means for evaluating a test carrier which has undergone said detectable change comprising a measurement and digitization circuit for (a) measuring said physically detectable change, (b) generating a measurement signal and (c) converting the measurement signal into an intermediate result independent of the evaluation curve by digitization of the measurement signal into one of a finite number of digital output states;

display means for displaying the one of the finite number of digital output states in the form of alpha and/or numeric characters; and

a readable information carrier element associated with each test carrier or with each plurality of test carriers providing a correlation between the alpha and/or numeric characters corresponding to said digital output states and end result values determined in accordance with the evaluation curve, wherein said end result values correspond to a parameter of the component of the fluid sample, said readable information carrier element is specifically made for each test carrier manufacturing batch, and wherein the correlation of the alpha and/or numeric characters to the end result values may be different from batch to batch.

2. A test carrier analysis system according to claim 1, wherein the finite number of digital output states of the measurement and digitization circuit is less than 40.

3. A test carrier analysis system according to claim 1, wherein the finite number of digital output states of the measurement and digitization circuit is between 10 and 30.

4. A test carrier analysis system according to claim 1, wherein said measurement and digitization circuit further comprises means for assigning varying measurement signal differences to the finite number of digital output states of the measurement and digitization circuit in different parts of a value range of said measurement signal.

5. A method for analyzing a fluid sample to determine the concentration of a component of the fluid sample, comprising the steps of:

contacting a fluid sample with a test carrier containing at least one reagent in at least one test layer thereof to cause a reaction between said at least one reagent and a component of the fluid sample to produce a detectable change in said at least one test layer, wherein the detectable change follows a particular relationship, obeying an evaluation curve wherein a parameter of the fluid sample corresponds to the detectable change, of the concentration of the component of the fluid sample, and wherein the evaluation curve may vary with different manufacturing batch lots of the test carrier;

evaluating a test carrier which has undergone said detectable change by (a) providing a device for measuring said detectable change, (b) measuring said detectable change, (c) generating a measurement signal, and (d) converting the measurement signal into an intermediate result independent of the evaluation curve by digitization of the measurement signal into one of a finite number of digital output states;

displaying the one of the finite number of digital output states in the form of alpha and/or numeric characters corresponding to said finite number of digital output states for correlation with end result values determined in accordance with the evaluation curve, said end result values corresponding to the concentration of the component of the fluid sample;

providing a readable information carrier element associated with the test carrier providing a correlation between said alpha and/or numeric characters corresponding to said digital output states and said end result values determined in accordance with the evaluation curve, said readable information carrier element being specifically made for each manufacturing batch lots of the test carrier, wherein said correlation of the alpha and/or numeric characters to the end result values may be different from batch to batch; and

correlating said alpha and/or numeric characters with said end result values on said readable information carrier element to thereby determine the concentration of the component of the fluid sample.

6. A method for analyzing a fluid sample according to claim 5, wherein the finite number of digital output states is less than 40.

7. A method for analyzing a fluid sample according to claim 5, wherein the finite number of digital output states is between 10 and 30.

8. A method for analyzing a fluid sample according to claim 5, wherein the step of evaluating a test carrier further comprises assigning varying measurement signal differences to the finite number of digital output states in different parts of a value range of said measurement signal.

9. A method for analyzing a fluid sample according to claim 5, wherein said fluid sample comprises a body fluid.

10. A system for analyzing a fluid sample to determine the concentration of a component of the fluid sample, comprising:

a plurality of test carriers each containing at least one reagent in at least one test layer thereof;

an evaluation means for evaluating said plurality of test carriers, wherein upon contacting one of said test carriers with a fluid sample, a reaction occurs between said at least one reagent and a component of the fluid sample to produce a detectable change, said evaluation means evaluating said detectable change;

measuring means coupled to said evaluation means for measuring the physically detectable change;

generating means coupled to said measuring means for generating a measurement signal in response to said physically detectable change;

converting means coupled to said generating means for converting said measurement signal into an intermediate result, said intermediate result being independent of an evaluation curve of said plurality of test carriers;

display means for displaying an alpha and/or numeric character which corresponds to said intermediate result; and

a readable information carrier element corresponding to each of said plurality of test carriers, said readable information carrier element including information which correlates said alpha and/or numeric characters and end result values corresponding thereto, said end result values corresponding to concentrations of the component of the fluid sample.