Synchronized analyte testing system

• US 6,544,475 B1
• Filed: 04/10/2000
• Issued: 04/08/2003
• Est. Priority Date: 10/30/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Douglas, Joel S., Drexler, Karen R.
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/546,608
• Time in Patent Office: 1,093 Days
• Field of Search: 422/58, 422/61, 422/164, 422/169, 422/170, 422/174, 204/403, 204/406, 204/403.01, 204/403.04
• US Class Current: 422/402
• 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 system for detecting the presence of an analyte in a sample of biological fluid having a volume on the order of 3 μ

L, the system comprising;

a set of test strips; and

a detection device comprising a testing instrument having;

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

a sensor disposed at least partially in the housing and constructed to generate a signal responsive to reading the sample; and

a processor disposed at least partially in the housing and adapted to operate to generate a detection signal representative of the presence of the analyte in the sample;

wherein the detection device and test strips are constructed such that the system is capable of accurately detecting the analyte in the sample having a volume on the order of 3 μ

L.

2. The system of claim 1, wherein the processor contains calibration information.

3. A testing system for detecting the presence of an analyte in a sample of biological fluids, the system comprising:

a plurality of test pads;

a testing device comprising a housing, a sensor disposed at least partially in the is housing and adapted to generate a signal responsive to reading the sample, a processor disposed at least partially in the housing and adapted to generate a detecting signal representative of the presence of the analyte in the sample, and a permanent memory; and

calibration information corresponding to the plurality of test pads stored in the permanent memory of the testing device.

4. The system of claim 3, wherein each of the plurality of test pads are contained in a respective test strip.

5. A testing system for detecting the presence of an analyte in a sample of biological fluids, the system comprising:

a plurality of test pads;

a calibration chip containing calibration information corresponding to the plurality of test pads; and

a testing device comprising a housing, a sensor disposed at least partially in the housing and adapted to generate a signal responsive to reading the sample, a processor disposed at least partially in the housing and adapted to generate a detecting signal representative of the presence of the analyte in the sample and in accordance with the calibration information.

6. The system of claim 5, wherein each of the plurality of test pads are contained in a respective test strip.

7. A system, comprising:

a set of test strips;

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

a detection device comprising a testing instrument having

a housing;

a sensor at least partially within the housing and constructed to generate a signal responsive to reading the sample; and

a processor at least partially within the housing;

wherein the calibration means has means for limiting its use to a predetermined number of times which does not exceed the number of test strips in a given set such that the calibration means is disabled after reading the last test strip in the set.