Apparatus and method for analyzing a body fluid

• US 5,246,858 A
• Filed: 02/27/1991
• Issued: 09/21/1993
• Est. Priority Date: 02/27/1991
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation
• Inventors: Jost, Friedrich, Grant, Michael E., Storvick, David E., Gregory, Mark A., Riedel, Richard, Kennedy, Daniel L., Stoughton, John W., Perin, Dino, Arbuckle, Steven R., Boyd, William R., Gray, Russell T.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Kim, Christopher Y.
• Application Number:
  US07/661,810
• Time in Patent Office: 937 Days
• Field of Search: 436/8, 436/95, 436/34, 436/164, 436/165, 422/56, 422/82.05, 422/82.09, 422/68.1, 422/58, 356/445, 356/446
• US Class Current: 436/8
• CPC Class Codes: G01N 2021/478 Application in testing analytical test strips
• 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 2201/1214 for humidity
• CPC Class Codes: G01N 2201/122 Kinetic analysis; determining reaction rate
• CPC Class Codes: G01N 2201/12723 Self check capacity; automatic, periodic step of checking
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A method and apparatus (10) for determining the remission of a chemistry (106) which reacts with a medically significant component of a body fluid. The remission of the chemistry (106) changes as it reacts. The method and apparatus (10) include irradiating the chemistry (106) with a radiation source (182), detecting remissions of radiation from the chemistry (106) with a radiation detector (300), providing a radiation pathway (164) between the source (182) and the chemistry (106), providing a remission pathway (164) between the chemistry (106) and the detector (300), and detecting the rate of change of remission of the chemistry (106) with respect to time. The irradiating, detecting and rate detecting steps and apparatus comprise initially irradiating the chemistry (106) at a first time rate and detecting remissions therefrom, comparing remission data from remission readings spaced apart by a first number of intervening remission readings, and determining when the difference between compared readings exceeds a first predetermined limit. The time rate of irradiation of the chemistry is changed once the difference between compared readings exceeds the first limit. Remission data from remission readings spaced apart by a second number of intervening remission readings are then compared. The method and apparatus next determine when the difference between compared readings no longer exceeds a second predetermined limit. The last remission reading is then converted to the concentration of the medically significant component of the body fluid.

Claims

1. Apparatus for determining the remission of a chemistry which reacts with a medically significant component of a body fluid, the remission of the chemistry changing as it reacts, the apparatus comprising a source of radiation for irradiating the chemistry, a remission detector for detecting remissions of radiation from the chemistry, means for providing a radiation pathway between the source and the chemistry, means for providing a remission pathway between the chemistry and the remission detector, and means for determining the rate of change of remission of the chemistry with respect to time, the rate determining means comprising means for initially stimulating the radiation source at a first time rate, for receiving remission data from the remission detector, for comparing remission data from remission measurements spaced apart by a first number of intervening remission measurements, for determining when the difference between compared data exceeds a first predetermined limit, for changing the time rate of stimulation of the radiation source to a second and greater rate of stimulation per unit time once the difference between compared data exceeds the first limit, for comparing remission data from remission measurements spaced apart by a second number of intervening remission measurements, which second number may be the same as, or different from, the first number, for determining when the difference between compared data no longer exceeds a second predetermined limit, and for converting remission data identified based upon determining when the difference between compared data no longer exceeds the second limit to the concentration of the medically significant component of the body fluid, and means for coupling the radiation source and remission detector to the rate determining means.

2. The apparatus of claim 1 wherein the remission detector comprises a radiation sensitive device, and further comprising a capacitor for providing a first current flow through the radiation sensitive device in response to detection of remission, the first current flow discharging the capacitor from a known, initial, charged condition, and a constant current source for recharging the capacitor to the known, initial, charged condition when the first current flow terminates.

3. The apparatus of claim 2 wherein the rate determining means comprises a time base generator, means for measuring the time interval required for the constant current source to recharge the capacitor to the known, initial, charged condition, and means for coupling the time interval measuring means to the time base generator.

4. The apparatus of claim 1 comprising a substrate for supporting the chemistry, a device for accepting the substrate, the device defining the pathway along which radiation is guided from the radiation source to the chemistry when the substrate is inserted into the device and the pathway along which remission is guided from the chemistry to the remission detector when the substrate is inserted into the device, a remission standard, means for movably supporting the remission standard to permit it to move from a position in which it receives radiation from the radiation source and produces a standard remission which is guided along the pathway to the remission detector when no substrate is inserted into the device to a position separated from the radiation source by the substrate when the substrate is inserted into the device.

5. The apparatus of claim 4 wherein the means for movably supporting the remission standard further comprises means for supporting the radiation source, the pathway along which radiation is guided from the source to the chemistry when the substrate is inserted into the device including a first slot formed opposite the chemistry when a substrate is inserted into the device, the first slot being located adjacent the means for supporting the radiation source for directing radiation therefrom onto the chemistry when a substrate is inserted into the device.

6. The apparatus of claim 5 wherein the pathway along which remission is guided from the chemistry to the remission detector when a substrate is inserted into the device also includes the first slot.

7. The apparatus of claim 6 wherein the means for movably supporting the remission standard includes a first surface, the pathway along which remission is guided from the chemistry to the remission detector when a substrate is inserted into the device including a second slot formed in the first surface adjacent the first slot.

8. The apparatus of claim 7 wherein the means for movably supporting the remission standard includes a second surface lying at a nonzero angle to the first surface, the pathway along which radiation is guided from the source to the chemistry when the substrate is inserted into the device including a third slot formed in the second surface.

9. The apparatus of claim 8 wherein the third slot lies between the source and the chemistry when the substrate is inserted into the device.

10. The apparatus of claim 9 wherein the first slot lies between the third slot and the chemistry when the substrate is inserted into the device.

11. The apparatus of claim 10 wherein the first slot lies between the chemistry and the remission detector when the substrate is inserted into the device.

12. The apparatus of claim 11 wherein the second slot lies between the first slot and the remission detector.

13. The apparatus of claim 8 wherein the second surface lies between the means for supporting the radiation source and the chemistry when the substrate is properly inserted into the device.

14. The apparatus of claim 5 and further comprising a second radiation source and a second remission detector, and wherein the means for movably supporting the remission standard further includes a first surface which lies adjacent the first slot when the substrate is properly inserted into the housing, the first surface lying adjacent the device, and a second pathway along which radiation is guided from the second radiation source to the substrate when the substrate is inserted into the device and along which remission is guided from the substrate to the second remission detector when the substrate is inserted into the device.

15. The apparatus of claim 14 and further comprising an instrument for determining the concentration of a medically significant component of a body fluid and for indicating the determined concentration of the medically significant component to a user of the instrument, the instrument comprising an instrument case for the instrument'"'"'s components including the device, one of the instrument'"'"'s components comprising a printed circuit board, at least a portion of the means for movably supporting the remission standard, the first-mentioned and second radiation sources and the radiation source and the second radiation source and the remission detector and the second remission detector being mounted on the printed circuit board.

16. A method for determining the remission of a chemistry which reacts with a medically significant component of a body fluid, the remission of the chemistry changing as it reacts, the method comprising the steps of irradiating the chemistry, detecting remissions of radiation from the chemistry, providing a radiation pathway between a radiation source and the chemistry, providing a remission pathway between the chemistry and a remission detector, and determining the rate of change of remission of the chemistry with respect to time, the irradiating, remission detecting and rate determining steps together comprising the steps of initially irradiating the chemistry at a first time rate and detecting remissions therefrom, comparing remission data from remission measurements spaced apart by a first number of intervening remission measurements, determining when the difference between composed data exceeds a first predetermined limit, changing the time rate of irradiation of the chemistry to a second and greater rate of irradiation per unit time once the difference between compared data exceeds the first limit, comparing remission data from remission measurements spaced apart by a second number of intervening remission measurements, which second number may be the same as, or different from, the first number, determining when the difference between compared data no longer exceeds a second predetermined limit, and converting remission data identified based upon determining when the difference between compared data no longer exceeds a second predetermined limit to the concentration of the medically significant component of the body fluid.

17. The method of claim 16 and further comprising the step of providing a first current flow through a radiation sensitive device in response to detection of remission, the first current flow discharging a capacitor from a known, initial, charged condition, and providing a constant current for recharging the capacitor to the known, initial, charged condition when the first current flow terminates.

18. The method of claim 17, the rate determining step comprising the steps of generating a time base, and measuring the time interval required for the constant current to recharge the capacitor to the known, initial, charged condition.

19. The method of claim 16 comprising the steps of supporting the chemistry on a substrate, accepting the substrate in a device providing the pathway along which radiation is guided from the radiation source to the chemistry when the substrate is inserted into the device and along which remission is guided from the chemistry to the remission detector when the substrate is inserted into the device, providing a remission standard, and movably supporting the remission standard to permit it to move from a position in which it receives radiation from the radiation source and produces a standard remission which is guided along the pathway to the remission detector when no substrate is inserted into the device to a position separated from the radiation source by the substrate when the substrate is inserted into the device.

20. The method of claim 19 and further comprising irradiating the substrate with a second radiation source and detecting remissions from the substrate with a second remission detector, and providing a second pathway along which radiation is guided from the second radiation source to the substrate when the substrate is inserted into the device and along which remission is guided from the substrate to the second remission detector when the substrate is inserted into the device.

21. The method of claim 20 and further comprising the steps of providing an instrument for determining the concentration of a medically significant component of a body fluid and for indicating the determined concentration of the medically significant component to a user of the instrument, providing in the instrument a printed circuit board for mounting at least a portion of the remission standard, the radiation source and the second radiation source and the remission detector and the second remission detector.

22. The method of claim 20 wherein the steps of detecting the remissions detected by the remission detector and the second remission detector comprise the steps of detecting the remissions detected by the remission detector and the second remission detector substantially simultaneously.

23. The method of claim 16 wherein the steps of initially irradiating the chemistry at a first time rate, comparing remission data from remission measurements spaced apart by a first number of intervening remission measurements, determining when the difference between compared data exceeds a first predetermined limit, and determining when the difference between compared data no longer exceeds a second predetermined limit together comprise the steps of retrieving data representative of the first time rate, the first number of intervening remission measurements, the first predetermined limit, and the second predetermined limit from a read only memory (ROM), and further comprising the step of retrieving from the ROM data representative of a conversion parameter for converting the remission data identified based upon determining when the difference between compared data no longer exceeds the second limit to the concentration.

24. The method of claim 23 and further comprising the steps of providing an instrument for determining the concentration of a medically significant component of a body fluid and for indicating the determined concentration of the medically significant component to a user of the instrument, providing the ROM on a key, providing on the instrument a socket for receiving the key, insertion of the key into the socket coupling the ROM to the instrument and permitting access by the instrument to the data representative of the first time rate, the first number of intervening remission measurements, the first predetermined limit, the second predetermined limit, and the conversion parameter.