Synchronized analyte testing system

• US 5,872,713 A
• Filed: 10/30/1997
• Issued: 02/16/1999
• Est. Priority Date: 10/30/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Roe, Jeffrey N., Douglas, Joel S., Drexler, Karen R.
• Primary Examiner(s): STUCKER, JEFFREY J
• Application Number:
  US08/960,866
• Time in Patent Office: 474 Days
• Field of Search: 435/4, 435/14, 435/808, 435/817, 436/164, 436/169, 422/56, 422/58, 422/61, 422/67, 422/82.01, 422/82.02, 422/82.05, 422/82.06, 364/413.09, 204/403, 204/406, 204/407
• US Class Current: 702/85
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01D 3/022 having an ideal characteristic, map or correction data stored in a digital memory
• CPC Class Codes: G01N 2035/00138 Slides
• 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 33/48757 : Test elements dispensed from a stack
• CPC Class Codes: G01N 33/48771 : Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/525 : Multi-layer analytical elements
• CPC Class Codes: G01N 33/528 : Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/66 : involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/808 : Optical sensing apparatus
• CPC Class Codes: Y10S 435/817 : Enzyme or microbe electrode

Abstract

An analyte detection system is provided with calibration information uniquely specific to the set of test strips to which the sample is to be applied. The calibration information may be stored in permanent memory of the testing device, such that the device is discarded after use of all the test strips in a kit, or it may be stored in a calibration chip accompanying the set of test strips and distributed therewith, thereby enabling re-use of the testing device with a different set of test strips and associated calibration chip.

Claims

1. A synchronized detection device for detecting the presence of an analyte in a sample based on a physically detectable reaction of the sample with a reagent the device comprising:

a set of test strips each containing the reagent disposed thereon, each set containing at least one test strip;

calibration means corresponding to the set of test strips and containing calibration information uniquely characteristic to the reagent in the set of test strips;

a housing having a docking portion for engaging at least one of the test strips;

a sensor disposed at least partially in the housing an adapted to generate an electrical signal responsive to the reaction of the sample with the reagent;

a processor disposed at least partially in the housing an adapted to operate in accordance with the calibration means to generate a detection signal representative of the presence of the analyte in the sample;

the detection device is adapted for use a predetermined number of times, the processor tabulating the predetermined number of times using information contained in the calibration means; and

the processor disabling use of the detection device after the predetermined number of times.

2. The device of claim 1, wherein the detection device is adapted for use a predtermined number of times corresponding to the number of test strips in the set.

3. The device of claim 1, wherein the processor is adapted to disable use of the detection device after a predetermined date.

4. The device of claim 1, wherein the calibration means comprises a chip containing correlation information for correlating the electrical signal to the detection signal.

5. The device of claim 4, wherein the detection device is adapted for use a plurality of said chips, each chip corresponding to an associated set of test strips and adapted to detachably connect to the housing.

6. The device of claim 4, wherein the correlation information is based on a predetermined mathematical function.

7. The device of claim 4, wherein the correlation information is based on a lookup table.

8. The device of claim 5, wherein each chip is adapted for use a predetermined number of times corresponding to the number of test strips in an associated set, the predetermined number of times being tabulated by the processor, the processor disabling use of the chip after the predetermined number of times.

9. The device claim 5, wherein each chip is adapted for use up to a predetermined date, the processor disabling the use of the chip after the predetermined date.

10. The device of claim 1, wherein the calibration means devices correlation information from a master test strip contained in the set.

11. The device of claim 1, wherein the docking portion is adapted to positively locate the test strip in a predtermined orientation relative to the sensor.

12. The device of claim 11, wherein the docking portion is adapted to matingly engage the test strip using engagment pins and corresponding holes such that only a successful mating achieves the predetermined orientation.

13. The device of claim 1, wherein the sensor comprises at least one LED and associated photodetector.

14. The device of claim 13, wherein the sensor comprises a first LED adapted to operate below a threshold radiation intensity and a second LED adapted to operate above the threshold radiation intensity.

15. The device of claim 13, wherein the sensor comprises a first LED adapted to detect total reflectance from the reaction and a second LED adapted to measure reflectance of a predetermined color component of the reaction.

16. The device of claim 13, wherein the sensor is provided with at least one molded lens optic system for focusing light.

17. The device of claim 1, further comprising a memory for storing the detection signal.

18. The device of claim 17, further comprising a modem for downloading the detection signal from the memory to a location remote from the detection device.

19. The device of claim 18, wherein the modem is disposed in a communication module which detachably engages the detection device for communication therewith, and which communicates with a storage device located at the remote location.

20. The device of claim 1, wherein the detection device is activated by an electromechanical switch triggered by the presence of a test strip in the docking portion.

21. The device of claim 1, wherein the detection device is activated by an optical switch triggered by the presence of a test strip in the docking portion.

22. The device of claim 1, wherein the detection device is activated by a pair of electrodes which sense the presence of the sample on a test strip disposed in the docking portion.

23. The device of claim 1, wherein the sensor comprises a pair of electrodes in electrical communication with sample.

24. The device of claim 13, wherein the photodetector is shielded from ambient radiation.

25. The device of claim 1, wherein a set of samplers is provided with the detection device, the number of samplers corresponding to the number test strips.

26. The device of claim 1, wherein the detection signal is displayed on a displayed disposed on the housing.

27. The device of the claim 26, wherein the display is an LCD device.

28. The device of claim 4, further comprising a memory, the correlation information being uploaded from the chip and stored in the memory.

29. The device of claim 28, wherein the chip is disabled following uploading.

30. The device of claim 28, further comprising a mechanical latch preventing multiple uploadings.

31. The device of claim 4, wherein the chip is provided with a counter, the correlation information being read by the processor a predetermined number of times corresponding to the number of test strips in an associated set of test strips, the counter being decremented with each reading.

32. The device of claim 1, wherein the processor prevents use of the calibration means following a predetermined duration.

33. The device of claim 1, wherein a sampling device is provided with the detection device.

34. The device of claim 25, wherein a sampling device is provided with the detection device.

35. The device of claim 4, wherein the chip is read once and disabled, the calibration information being stored for a specific number of tests corresponding to the number of test strips in associated set of test strips.

36. The device of claim 4, wherein the chip comprises an EEPROM.

37. The device of claim 4, wherein the chip comprises a microprocessor adapted to permit intelligent data transfer.

38. The device of claim 4, wherein the chip comprises an EPROM.

39. The device of claim 1, wherein the calibration means comprises a ROM contained within the housing of the device.