CA2437681A1 - Diagnostic kit with a memory storing test strip calibration codes and related methods - Google Patents
Diagnostic kit with a memory storing test strip calibration codes and related methods Download PDFInfo
- Publication number
- CA2437681A1 CA2437681A1 CA002437681A CA2437681A CA2437681A1 CA 2437681 A1 CA2437681 A1 CA 2437681A1 CA 002437681 A CA002437681 A CA 002437681A CA 2437681 A CA2437681 A CA 2437681A CA 2437681 A1 CA2437681 A1 CA 2437681A1
- Authority
- CA
- Canada
- Prior art keywords
- test strip
- calibration
- diagnostic kit
- calibration codes
- codes
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
- G01N33/48771—Coding of information, e.g. calibration data, lot number
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
- Y10T436/104998—Glucose, ketone, nitrate standard or control
Abstract
A diagnostic kit for measuring a characteristic of a fluid sample includes a test strip (e.g., a disposable blood glucose test strip) and device (e.g., a hand-held meter) for measuring a property (e.g., an optical or electrochemical property) of the test strip. The device also calculates, based on the measured property of the test strip, a characteristic (e.g., blood glucose concentration or INR) of a fluid sample applied to the test strip.
Stored in a memory of the device are test strip calibration codes that represent geometric regions (e.g., polygonal or hexagonal geometric regions) of a multi-dimensional calibration parameter space. The test strip calibration codes and geometric regions are distributed across the multi-dimensional calibration parameter space such that a quantization error of assigning one of test strip calibration codes to the test strip is optimally reduced. Also, a method for optimally associating test strip calibration codes to calibration parameters for use in such a diagnostic kit that includes first optimally distributing a plurality of test strip calibration codes and geometric regions represented thereby across a multi-dimensional calibration parameter space. The distribution is conducted such that a quantization error of assigning one of the test strip calibration codes to the test strip of the diagnostic kit is optimally reduced. The method also includes storing the distributed test strip calibration codes in a memory of the diagnostic kit.
Stored in a memory of the device are test strip calibration codes that represent geometric regions (e.g., polygonal or hexagonal geometric regions) of a multi-dimensional calibration parameter space. The test strip calibration codes and geometric regions are distributed across the multi-dimensional calibration parameter space such that a quantization error of assigning one of test strip calibration codes to the test strip is optimally reduced. Also, a method for optimally associating test strip calibration codes to calibration parameters for use in such a diagnostic kit that includes first optimally distributing a plurality of test strip calibration codes and geometric regions represented thereby across a multi-dimensional calibration parameter space. The distribution is conducted such that a quantization error of assigning one of the test strip calibration codes to the test strip of the diagnostic kit is optimally reduced. The method also includes storing the distributed test strip calibration codes in a memory of the diagnostic kit.
Claims (32)
1. A diagnostic kit for measuring a characteristic of a fluid sample, the diagnostic kit comprising:
a test strip; and a device for measuring at least one property of the test strip and calculating, therefrom, a characteristic of a fluid sample applied to the test strip, the device including:
a memory with a plurality of test strip calibration codes stored therein, each of the test strip calibration codes representing a geometric region of a calibration parameter space, wherein the test strip calibration codes and geometric regions are distributed across the calibration parameter space such that a quantization error of assigning one of the test strip calibration codes to the test strip is optimally reduced.
a test strip; and a device for measuring at least one property of the test strip and calculating, therefrom, a characteristic of a fluid sample applied to the test strip, the device including:
a memory with a plurality of test strip calibration codes stored therein, each of the test strip calibration codes representing a geometric region of a calibration parameter space, wherein the test strip calibration codes and geometric regions are distributed across the calibration parameter space such that a quantization error of assigning one of the test strip calibration codes to the test strip is optimally reduced.
2. The diagnostic kit of claim 1, wherein each of the test strip calibration codes represents a geometric region of a multi-dimensional calibration parameter space.
3. The diagnostic kit of claim 1, wherein the test strip and device are adapted to measure a blood glucose concentration of a blood sample and wherein the device employs an algorithm of the simplified form:
G=I P(C0-Z) where:
G = blood glucose concentration;
I and C0 are measured properties of the test strip; and p and Z are calibration parameters;
to calculate blood glucose concentration and wherein the test strip calibration codes represent hexagonal geometric regions of a two-dimensional p-Z calibration parameter space.
G=I P(C0-Z) where:
G = blood glucose concentration;
I and C0 are measured properties of the test strip; and p and Z are calibration parameters;
to calculate blood glucose concentration and wherein the test strip calibration codes represent hexagonal geometric regions of a two-dimensional p-Z calibration parameter space.
4. The diagnostic kit of claim 3, wherein the test strip calibration codes are distributed across the two-dimensional p-Z calibration parameter space based on optimization using constant error equations.
5. The diagnostic kit of claim 3, wherein the test strip calibration codes represent one of hexagonal geometric regions and partial hexagonal geometric regions of the two-dimensional p-Z calibration parameter space.
6. The diagnostic kit of claim 5, wherein the test strip calibration codes are distributed using an incremental resolution based on the 95th percentiles of a calibration parameter calibration error.
7. The diagnostic kit of claim 1, wherein the test strip and device are adapted to measure INR a blood sample and wherein the device employs an algorithm of the form:
where:
PT is a prothrombin time measured by the device; and MNPT and ISI are calibration parameters to calculate INR and wherein the test strip calibration codes represent polygonal geometric regions of a two-dimensional MNPT-ISI calibration parameter space.
where:
PT is a prothrombin time measured by the device; and MNPT and ISI are calibration parameters to calculate INR and wherein the test strip calibration codes represent polygonal geometric regions of a two-dimensional MNPT-ISI calibration parameter space.
8. The diagnostic kit of claim 7, wherein the test strip calibration codes represent stepped polygonal geometric regions of the two-dimensional ISI-MNPT
calibration parameter space.
calibration parameter space.
9. The diagnostic kit of claim 7, wherein the stepped polygonal geometric regions are comprised of a plurality of adjacent parallelograms.
10. The diagnostic kit of claim 1, wherein the memory stores a plurality of test strip calibration codes that optimally reduce the quantization error by maintaining predetermined quantization error limits with a minimum number of test strip calibration codes.
11. The diagnostic kit of claim 10, wherein the predetermined quantization error limits are based on an accuracy requirement of the diagnostic kit.
12. The diagnostic kit of claim 1, wherein each of the test strip calibration codes represents one of a hexagonal geometric region or a partial hexagonal geometric region of a two-dimensional calibration parameter space.
13. The diagnostic kit of claim 1, wherein the memory stores a plurality of test strip calibration codes distributed such that each of the test strip calibration codes represent a polygonal geometric region of a two-dimensional calibration parameter space.
14. The diagnostic kit of claim 13, wherein the polygonal geometric region is a stepped polygonal geometric region comprised of a plurality of adjacent parallelograms.
15. The diagnostic kit of claim 1, wherein the test strip is a disposable blood glucose test strip and the device is a hand-held meter for measuring an optical property of the disposable blood glucose test strip.
16. The diagnostic kit of claim 1, wherein the test strip is a disposable blood glucose test strip and the device is a hand-held meter for measuring an electrochemical property of the disposable blood glucose test strip.
17. The diagnostic kit of claim 1, wherein the test strip is a prothrombin test strip and the device is a device for measuring optical properties of the prothrombin test strip.
18. The diagnostic kit of claim 1, wherein the predetermined test strip calibration codes are distributed across the calibration parameter space further using a geometric pattern that is dependent on an objective function that defines overall test strip calibration error.
19. The diagnostic kit of claim 1, wherein the device is a hand-held meter.
20. The diagnostic kit of claim 1, wherein the fluid sample is a physiological fluid sample.
21. The diagnostic kit of claim 1, wherein the test strip has an associated calibration code.
22. A method for optimally associating test strip calibration codes to calibration parameters for use in a diagnostic kit that includes a test strip and a device with a memory, the method comprising:
distributing a plurality of test strip calibration codes and geometric regions represented by the test strip calibration codes across a calibration parameter space such that a quantization error of assigning one of the test strip calibration codes to the test strip is optimally reduced, thereby associating the test strip calibration codes with calibration parameters of the calibration parameter space; and storing the test strip calibration codes thus distributed in a memory of the diagnostic kit.
distributing a plurality of test strip calibration codes and geometric regions represented by the test strip calibration codes across a calibration parameter space such that a quantization error of assigning one of the test strip calibration codes to the test strip is optimally reduced, thereby associating the test strip calibration codes with calibration parameters of the calibration parameter space; and storing the test strip calibration codes thus distributed in a memory of the diagnostic kit.
23. The method of claim 22, wherein the distributing step distributes the test strip calibration codes across a multi-dimensional calibration parameter space.
24. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes that represent one of a hexagonal geometric region or a partial hexagonal geometric region of a two-dimensional calibration parameter space.
25. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes that represent polygonal geometric regions of a two-dimensional calibration parameter space.
26. The method of claim 25, wherein the distributing step distributes a plurality of test strip calibration codes that are associated with stepped polygonal geometric regions of a two-dimensional calibration parameter space.
27. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes by optimally reducing the quantization error based on an objective function related to performance of the diagnostic kit.
28. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes by optimally reducing the quantization error based on a Mean Absolute Bias (MAB) objective function.
29. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes by optimally reducing the quantization error based on constant error objective functions related to performance of the diagnostic kit.
30. The method of claim 22, wherein the distributing step distributes a plurality of test strip calibration codes by optimally reducing the quantization error based on a Mean Absolute Relative Deviation (MARD) objective function.
31 31. An assay kit for analyzing a sample, the assay kit comprising:
a reagent; and an analytical device employed in conjunction with the reagents to carry out a predetermined analysis of the sample, the analytical device including:
a memory with a plurality of reagent calibration codes stored therein, each of the reagent calibration codes representing a geometric region of a calibration parameter space, wherein the reagent calibration codes and geometric regions are distributed across the calibration parameter space such that a quantization error of assigning one of the reagent calibration codes to the reagent is optimally reduced.
a reagent; and an analytical device employed in conjunction with the reagents to carry out a predetermined analysis of the sample, the analytical device including:
a memory with a plurality of reagent calibration codes stored therein, each of the reagent calibration codes representing a geometric region of a calibration parameter space, wherein the reagent calibration codes and geometric regions are distributed across the calibration parameter space such that a quantization error of assigning one of the reagent calibration codes to the reagent is optimally reduced.
32. A method for optimally associating reagent calibration codes to calibration parameters for use in an assay kit that includes a reagent and an analytical device with a memory, the method comprising:
distributing a plurality of reagent calibration codes and geometric regions represented by the reagent calibration codes across a calibration parameter space such that a quantization error of assigning one of the reagent calibration codes to the reagent is optimally reduced, thereby associating the reagent calibration codes with calibration parameters of the calibration parameter space; and storing the reagent calibration codes thus distributed in a memory of the analytical device.
distributing a plurality of reagent calibration codes and geometric regions represented by the reagent calibration codes across a calibration parameter space such that a quantization error of assigning one of the reagent calibration codes to the reagent is optimally reduced, thereby associating the reagent calibration codes with calibration parameters of the calibration parameter space; and storing the reagent calibration codes thus distributed in a memory of the analytical device.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/224,888 | 2002-08-21 | ||
US10/224,888 US6780645B2 (en) | 2002-08-21 | 2002-08-21 | Diagnostic kit with a memory storing test strip calibration codes and related methods |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2437681A1 true CA2437681A1 (en) | 2004-02-21 |
CA2437681C CA2437681C (en) | 2011-07-19 |
Family
ID=31187982
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2437681A Expired - Fee Related CA2437681C (en) | 2002-08-21 | 2003-08-20 | Diagnostic kit with a memory storing test strip calibration codes and related methods |
Country Status (11)
Country | Link |
---|---|
US (1) | US6780645B2 (en) |
EP (1) | EP1391728B1 (en) |
JP (1) | JP2004132964A (en) |
KR (1) | KR20040018161A (en) |
CN (1) | CN100587488C (en) |
CA (1) | CA2437681C (en) |
ES (1) | ES2519791T3 (en) |
HK (1) | HK1061573A1 (en) |
IL (1) | IL157381A (en) |
SG (1) | SG109525A1 (en) |
TW (1) | TWI317810B (en) |
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