Automatic test parameters compensation of a real time fluid analysis sensing device

• US 5,821,399 A
• Filed: 01/16/1996
• Issued: 10/13/1998
• Est. Priority Date: 07/16/1993
• Status: Expired due to Term

• Current Assignee: i STAT Corporation (Abbott Laboratories Incorporated)
• Original Assignee: i STAT Corporation (Abbott Laboratories Incorporated)
• Inventors: Zelin, Michael P.
• Primary Examiner(s): Williams, Hezron E.
• Assistant Examiner(s): LARKIN, DANIEL SEAN
• Application Number:
  US08/656,276
• Time in Patent Office: 1,001 Days
• Field of Search: 73/1.02, 73/1.03, 73/64.53, 204/400, 204/403, 204/409, 324/439, 422/61, 422/63, 422/82, 422/82.02, 436/8, 436/43, 436/808
• US Class Current: 73/1.02
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001

Abstract

A method for automatic fluid flow compensation in disposable fluid analysis sensing devices is disclosed. The method is designed to keep the test conditions from sample to sample substantially unchanged. This is accomplished by using information about the preceding and/or current test measurements to automatically offset parameter variations of the disposable devices and the reading apparatus caused by manufacturing tolerances, wear of the mechanical parts, fluid viscosity differences and others. At each consecutive test measurement the method uses a compensation of the position of the actuating element to offset the difference between the previous test measurement and a factory pre-specified value. The method and system result, over the lifetime of the instrument, in a substantially unchanged flow of the analyzed fluid and reduction of the influence of a variety of external factors on the test measurements.

Claims

1. An automatic compensation method for maintaining close to a target value a mean fluid displacement of test samples in a succession of test measurements of a fluid sensing instrument which includes an actuation mechanism for the displacement of at least one fluid along a predetermined fluid path and at least one sensor, the method comprising the steps of:

(a) recording the time of arrival of each fluid at the sensor by measuring an output characteristic of the sensor;

(b) for each successive test measurement determining the variation of the recorded arrival time from a predetermined value; and

(c) compensating, in response to the determined variation, the motion of the fluid actuation mechanism in successive test measurements to keep the mean fluid displacement close to the target value.

2. The method of claim 1 wherein the fluid path and the sensor are positioned in a disposable cartridge device replaced after each test measurement.

3. The method of claim 1 wherein measurements of the output characteristics of the sensor in step (a) are stored in a memory during each test measurement and are compared at step (b) of the method to a value determined by a factory preset value corresponding to an average expected fluid arrival time.

4. The method of claim 1 wherein step (b) further comprises the step of comparing the determined variation to preset maximum deviation limits and discontinuing the test measurement if the determined variation is larger than the preset limits.

5. The method of claim 4 wherein the motion compensation of the actuation mechanism at step (c) is computed for each test sample from a factory preset value corresponding to an average expected fluid arrival time for test samples and from a value which is determined by the cumulative correction of variations in the previous test measurements.

6. The method of claim 4 wherein a unit compensation of the motion of the fluid actuation mechanism at step (c) in each test measurement has a constant value which is independent of the value of the determined variations which are within the maximum deviation limits.

7. The method of claim 1 wherein a unit compensation of the motion of the fluid actuation mechanism at step (c) in each test measurement is done in response to the sign of the determined variation.

8. The method of claim 1 wherein the sensor measures the electrical conductivity of the fluids passing along the fluid path.

9. The method of claim 8 wherein fluid samples in one test measurement having similar electrical conductivities are physically separated as to cause large deviations in the measured electrical conductivity signal at the output of the sensor.

10. The method of claim 1 wherein in step (c) the compensation is different from a zero value only for every M-th measurement, where the value of M is selected between 2 and 100.

11. The method of claim 2 wherein the compensation of the fluid actuation mechanism is adapted to reduce the effects of a physical wear of the parts of the sensing instrument over a number of test measurements.

12. The method of claim 2 wherein the compensation of the fluid actuation mechanism is adapted to reduce the effects of the differences between individual fluid test samples over a number of test measurements.

13. The method of claim 1 wherein the test measurement for each test sample is conducted in a prespecified constant time.

14. A system for sensing at least one component concentration in a fluid test sample, comprising a reading apparatus and a disposable sensing device, the disposable sensing device comprising:

at least one sensor;

sample retaining means for retaining the fluid sample out of contact with the sensor prior to sensing;

a sample conduit connecting the sample retaining means with the sensor; and

sample displacement means for automatically and forcibly displacing the sample through the sample conduit and into contact with the sensor to enable sensing;

the reading apparatus comprising;

receiving means for receiving the disposable sensing device;

control means for controlling the automatic displacement of the fluid test sample by the sample displacement means of the disposable sensing device;

first memory means to store output characteristics of the sensor; and

automatic compensation means for maintaining close to a target value the mean fluid displacement by adjusting input parameters of the control means in response to the stored output characteristics following each measurement.

15. The system of claim 14 wherein the reading apparatus further comprises a second memory means to store preset values and means for comparing values stored in the first memory means and the second memory means to determine input parameters of the compensation means.

16. The system of claim 15 wherein the reading apparatus further comprises means for displaying the results of the sensing and for providing an indication to the user whenever the output characteristics of the sensor are outside specified limits stored in the second memory means.

17. The system of claim 14 wherein said target value of the mean fluid displacement is dynamically adjustable.

18. An automatic compensation method for maintaining close to a target value the mean fluid displacement samples in a succession of test measurements of a fluid sensing instrument which includes an actuation mechanism for the displacement of fluids along a predetermined fluid path during each test measurement and at least one sensor, the method comprising the steps of:

(a) storing in memory means a parameter associated with the target value of test fluid volume required to pass over the sensor;

(b) recording the time of arrival of the test fluids at the sensor by measuring an output characteristic of the sensor;

(c) following the recorded time of arrival, for each test fluid sample comparing an output characteristic of the sensor to the stored parameter value; and

(d) compensating in response to the comparison the motion of the fluid actuation mechanism to keep the mean test sample fluid volume close to the target value.

19. The method of claim 18 wherein the parameter associated with the target value of test fluid volume is the time required for the test sample to pass over the sensor for a constant speed of motion of the fluid actuation mechanism.

20. The method of claim 18 wherein the parameter associated with the target value of test fluid volume is the speed of motion of the actuation mechanism for a constant test measurement time.