Method for determining the glucose content of a blood sample

• US 6,448,067 B1
• Filed: 03/31/2000
• Issued: 09/10/2002
• Est. Priority Date: 10/03/1997
• Status: Expired due to Fees

• Current Assignee: 77 Elektronika Muszeripari Kft.
• Original Assignee: 77 Elektronika Muszeripari Kft.
• Inventors: Tajnaföi, Gábor
• Primary Examiner(s): Beisner, William H.
• Application Number:
  US09/540,713
• Time in Patent Office: 893 Days
• Field of Search: 435/286.1, 435/288.7, 435/287.9, 435/805, 422/55-58, 422/82.05, 422/82.06, 436/66, 436/67, 436/164, 436/805, 356/445, 356/448, 356/39, 600/365-367
• US Class Current: 435/288.7
• 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 2201/129 Using chemometrical methods

Abstract

The invention relates to a method and apparatus for determining a chemical component from a sample, where the sample is measured on a test strip with the help of a color reaction. The method concerns finding the measurement time T_m for measuring the reflection of the test strip. The method comprises the following steps: a) Recording the R(t) function, b) Determining the T₀ starting time at the detection of the wetting through of the sample, c) Generating the function R(t)+L(t), d) Monitoring and storing the ext[R(t)+L(t)] extreme value of the R(t)+L(t) function, and, at the same time, e) Generating the function R(t)+L(t)−ext[R(t)+L(t)] from the time of reaching an ext[R(t)+L(t)] extreme value, f) when the R(t)+L(t)−ext[R(t)+L(t)] function reaches a predetermined C(t) value, determining the T_m measuring time.

Claims

1. An apparatus for determining a chemical component from a sample of matter, the apparatus comprising:

a sample holder for accommodating a test strip, the test strip being configured to receive the sample on one side of the test strip, the test strip including a reagent, the reagent being configured to cause a color reaction, directly or through an intermediate reaction, with the chemical component, and the test strip being further configured such that components of the sample penetrate the test strip and start the color reaction at an opposing side of the test strip;

a light source for illuminating the sample placed into the sample holder;

a measuring circuit for measuring the intensity of the light reflected from the sample and generating an output signal corresponding to the intensity of the light;

a controller and analyzer circuit for receiving the output signal from the measuring circuit, where the controller and analyzer circuit is configured to determine the chemical component of the sample by;

illuminating the sample and measuring a reflection R from the test strip and recording a reflection function R(t),

detecting a wetting through of the sample,

determining a starting time T₀, where the starting time T₀ is not earlier than the time of detection of wetting through of the sample,

generating from the starting time T₀, a function R(t)+L(t), where L(t) is a predetermined function that is independent of the measured reflection, monitoring and storing an extreme value ext[R(t)+l(T)] of the R(t)+L(t) function,

generating a function R(t)+L(t)−

ext[R(t)+L(t)] from the time of reaching at least one value for extreme value ext[R(t)+L(t)],

where the R(t)+L(t)−

ext[R(t)+L(t)] function reaches a predetermined C(t) value, determining a T_m measuring time, C(t) being a predetermined function independent of the measured reflection, and

determining from the R reflection value measured at the T_m measuring time an amount of the chemical component in the sample.

2. The apparatus of claim 1, where the controller and analyzer circuit is further configured to measure the reflection R at one of discrete time intervals and substantially continuously.

3. The apparatus of claim 1, where the controller and analyzer circuit is further configured to store a minimum value min[R(t)+L(t)] as the extreme value ext[R(t)+L(t)] of the R(t)+L(t) function.

4. The apparatus of claim 1, where the controller and analyzer circuit is further configured to generate the function R(t)+L(t)−

ext[R(t)+L(t)] upon reaching a definite (true) value for the extreme value ext[R(t)+L(t)].

5. The apparatus of claim 1, where the sample of matter farther comprises a blood sample and the chemical component further comprises glucose.

6. The apparatus of claim 1, the apparatus further comprising a storage circuit configured to store values for one of the L(t) and C(t) functions in tabular form, the storage circuit being coupled to the controller and analyzer circuit.

7. The apparatus of claim 1, where the controller and analyzer circuit further comprises a microprocessor.

8. An apparatus for determining a chemical component from a sample of matter, the apparatus comprising:

means for accommodating a test strip, the test strip being configured to receive the sample on a reagent, the reagent being positioned on one side of the test strip, the reagent being configured to cause a color reaction, directly or through an intermediate reaction, with the chemical component to be measured, and the test strip being configured so that components of the sample penetrate the test strip and start the color reaction at the other side of the test strip; and

means for measuring a content amount of a component in the sample through optical reflection measurement of the resulting color reaction by illuminating the sample and measuring at discrete time intervals or substantially continuously a reflection R on the test strip and recording a function R(t);

means for detecting a wetting through of the sample in order to determine a starting time T₀, where T₀ is not earlier than the time of detection of wetting through;

means for generating from the T₀ starting time a function R(t)+L(t), where L(t) is a predetermined function that is independent of the measured reflection;

means for monitoring and storing an extreme value ext[R(t) +L(t)] of the R(t)+L(t) function;

means for generating a function R(t)+L(t)−

ext[R(t)+L(t)] from a time of reaching at least one extreme value ext[R(t)+L(t)];

means for determining a T_m measuring time when the R(t)+L(t)−

ext[R(t)+L(t)] function reaches a predetermined C(t) value; and

means for determining the content of the chemical component in the sample by comparing the R reflection value measured at the T_m measuring time to a predetermined calibrated measurement.

9. The apparatus of claim 8, where the means for generating a function R(t)+L(t)−

ext[R(t)+L(t)] from a time of reaching at least one extreme value ext[R(t)+L(t)] further comprises means for generating the minimum value min[R(t)+L(t)] of the R(t)+L(t) function.

10. The apparatus of claim 8, where the sample further comprises a blood sample and the chemical component further comprises glucose.

11. The apparatus of claim 8, where L(t) further comprises a linear function with a predetermined slope, where L(t)=At+B, the variables A and B being constants.

12. The apparatus of claim 11, wherein B=0.

13. The apparatus of claim 8, wherein L(t) further comprises one of a second-order and a higher-order polynomial.

14. The apparatus of claim 8, where C(t) further comprises a constant function.

15. The apparatus of claim 8, where C(t) further comprises one of a first-order and a second-order polynomial.

16. The apparatus of claim 8, where the means for detecting the wetting through of the sample further comprises means for detecting the wetting through of the sample on the basis of one of:

a predetermined amount of change in reflection; and

a predetermined rate of change in reflection.

17. The apparatus of claim 8, wherein the means for detecting the wetting through of the sample further comprises means for detecting the wetting through of the sample on the basis of the reflection value R reaching a predetermined limit.

18. The apparatus of claim 8, where the step detecting the wetting through of the sample further comprises means for electrically detecting the wetting through of the sample on the basis of change in one of resistance and capacitance.

19. The apparatus of claim 8, where the sample further comprises one of full blood, blood plasma and serum.

20. The apparatus of claim 8, where the means for illuminating the sample further comprises means for illuminating the sample by applying illumination with an intensity substantially in the range of 0.01 to 1 mW and having a wavelength substantially in the range of 400 to 1550 nm.

21. A system for determining a chemical component from a sample of matter, the system comprising:

means for illuminating the sample and measuring a reflection R from a test strip and recording a reflection function R(t);

means for detecting a wetting through of the sample when the sample has been provided on the test strip;

means for determining a starting time T₀, where the starting time T₀ is not earlier than the time of detection of wetting through of the sample;

means for generating from T₀ starting time a function R(t)+L(t), where L(t) is a predetermined function that is independent of the measured reflection;

means for monitoring and storing an extreme value ext[R(t)+L(t)] of the R(t)+L(t) function;

means for generating a function R(t)+L(t)−

ext[R(t)+L(t)] from the time of reaching at least one value for extreme value ext[R(t)+L(t)];

means for determining a T_m measuring time when the R(t)+L(t)−

ext[R(t)+L(t)] function reaches a predetermined C(t) value, L(t) and C(t) being predetermined functions independent of the measured reflection; and

means for determining from the R reflection value measured at the T_m measuring time an amount of the chemical component in the sample.

22. The system of claim 21, where the means for illuminating the sample and measuring a reflection R includes means for measuring the reflection R at one of discrete time intervals and substantially continuously.

23. The system of claim 21, where the means for monitoring and storing an extreme value ext[R(t)+L(t)] of the R(t)+L(t) function includes means for storing a minimum value min[R(t)+L(t)] as the extreme value ext[R(t)+L(t)] of the R(t)+L(t) function.

24. The system of claim 21 where the means for generating a function R(t)+L(t)−

ext[R(t)+L(t)] from the time of reaching at least one value for extreme value ext[R(t)+L(t)] further comprises means for generating the function R(t)+L(t)−

ext[R(t)−

L(t)] upon reaching a definite (true) value for the extreme value ext[R(t)+L(t)].

25. The system of claim 21, where the sample of matter further comprises a blood sample and the chemical component further comprises glucose.