Method for detecting and compensating an underdosage of test strips

• US 7,488,602 B2
• Filed: 10/16/2003
• Issued: 02/10/2009
• Est. Priority Date: 10/18/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, Pachl, Rudolf
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US10/686,970
• Publication Number:
  US 20040136871A1
• Time in Patent Office: 1,944 Days
• Field of Search: 436/169, 436/514, 435/26, 600/316
• US Class Current: 436/169
• 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

Abstract

The invention concerns a method for detecting an underdosage of an analytical test element and optionally for compensating the underdosage. The invention also concerns an analytical system and a test element which are suitable for detecting an underdosage.

An underdosage of the test element can be reliably detected and optionally calculated by irradiating the analytical test element in a control wavelength range. For this purpose the test element contains a control substance which interacts with the radiation in the control wavelength range as a function of the contact with the applied amount of sample.

Claims

1. A method of operating an analyte evaluation instrument to determine the analyte content of a sample disposed on a test element, the method comprising:

operating an optical measuring device to determine the amount of the sample placed on the test element based on an interaction between a control substance disposed on the test element and a sample matrix of the sample;

operating the optical measuring device to determine the analyte content of the sample based on an interaction between a reagent disposed on the test element and the analyte in the sample; and

correcting the analyte content of the sample if the amount of the sample placed on the test element is determined to be less than a predetermined calibration value.

2. The method of claim 1, wherein:

determining the analyte content of the sample includes determining the glucose content of the sample.

3. The method of claim 1 wherein the interaction between the control substance and the sample matrix is a chemical reaction.

4. A system for detecting an underdosage of a test element, the system comprising:

an optical measuring device that includes (i) a light emitter device capable of illuminating the test element with (A) light capable of generating a first photometrically detectable signal upon interacting with a reagent disposed on the test element after the reagent interacts with an analyte contained in a sample disposed on the test element and (B) light capable of generating a second photometrically detectable signal upon interacting with a control substance disposed on the test element after the control substance interacts with a sample mafrix of the sample disposed on the test element and (ii) a light detector device capable of receiving the first photometrically detectable signal and the second photometrically detectable signal;

an electronic circuit operatively coupled to the optical measuring device, wherein the electronic circuit is configured to;

analyze the first photometrically detectable signal from the optical measuring device to determine the analyte content of the sample based on the concentration of the analyte in the sample, and

analyze the second photometrically detectable signal from the optical measuring device to determine whether an underdosage of the sample has occurred on the test element based on the interaction between the control substance and the sample matrix.

5. The system of claim 4 wherein:

the electronic circuit is further configured to correct the analyte content of the sample if the amount of the sample placed on the test element is determined to be less than a predetermined calibration value.

6. The system of claim 4 wherein the sample is blood, the analyte is glucose, and the electronic circuit is configured to:

analyze the first photometrically detectable signal from the optical measuring device to determine the glucose content of the sample, and

analyze the second photometrically detectable signal from the optical measuring device to determine whether an underdosage of blood has occurred on the test element.

7. An analyte evaluation instrument, comprising:

an optical measuring device, and

an electronic assembly electrically coupled to the optical measuring device, the electronic assembly being operable to;

operate the optical measuring device to assess the volume of a liquid sample placed on a test element, the assessment being based on an interaction between a control substance disposed on the test element and a sample matrix of the liquid sample, and

operate the optical measuring device to determine the analyte content of the liquid sample based on the concentration of the analyte in the liquid sample.

8. An analyte evaluation instrument, comprising:

an optical measuring device, and

an electronic assembly electrically coupled to the optical measuring device, the electronic assembly being operable to;

analyze output from the optical measuring device so as to assess the amount of sample placed on a test element, wherein the assessment is based on an interaction between a control substance disposed on the test element and a sample matrix of the sample,

analyze output from the optical measuring device to determine the analyte content of the sample, wherein the determination is based on an interaction between a reagent disposed on the test element and the analyte in the sample; and

the electronic assembly is further operable to correct the analyte content of the sample if the amount of the sample placed on the test element is determined to be less than a predetermined calibration value.

9. A system for evaluating the concentration of an analyte in a sample, comprising:

a test element having (i) a test field for accepting the sample, (ii) a reagent in the test field, the reagent being capable of interacting with the analyte in the sample, wherein the interaction between the reagent and the analyte causes a first photometrically detectable signal to be produced when the test field is illuminated with light, and (iii) a control substance in the test field, the control substance being capable of interacting with a sample matrix of the sample, wherein (A) the interaction between the control substance and the sample matrix causes a second photometrically detectable signal to be produced when the test field is illuminated with light and (B) the second photometrically detectable signal is a function of the amount of the sample applied to the test field;

an optical measuring device that includes (i) a light emitter device capable of illuminating the test field with light and (ii) a light detector device capable of receiving the first photometrically detectable signal and the second photometrically detectable signal; and

an electronic assembly electrically coupled to the optical measuring device, the electronic assembly being operable to;

analyze the first photometrically detectable signal received by the light detector device to determine the analyte content of the sample, wherein the determination is based on the interaction between the reagent in the test field and the analyte in the sample, and

analyze the second photometrically detectable signal received by the light detector device to assess the amount of sample placed on the test element to determine whether an underdosage of the sample has occurred, wherein the assessment is based on an interaction between the control substance in the test field and a sample matrix of the sample.

10. The system of claim 9 wherein:

the analyte in the sample is glucose.

11. The system of claim 9 wherein:

the sample is blood.