Apparatuses and methods for analyte concentration determination

• US 6,847,451 B2
• Filed: 05/01/2002
• Issued: 01/25/2005
• Est. Priority Date: 05/01/2002
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson), LifeScan IP Holdings, LLC
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Pugh, Jerry T.
• Primary Examiner(s): Smith, Zandra
• Assistant Examiner(s): GEISEL, KARA E
• Application Number:
  US10/137,097
• Publication Number:
  US 20030206302A1
• Time in Patent Office: 1,000 Days
• Field of Search: 356/436, 356/446, 356 39- 42, 422/82.05, 435/808
• US Class Current: 356/436
• 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

Abstract

Apparatuses and methods for determining the concentration of an analyte in a physiological sample are provided. The subject apparatuses include at least one light source, a detector array, means for determining whether a sufficient amount of sample is present on each of the plurality of different areas, and means for determining the concentration of the analyte based on the reflected light detected from those areas determined to have sufficient sample, where areas having insufficient sample are not used in analyte concentration determination. The subject methods include illuminating each area of a test strip, obtaining reflectance from each of the different areas, determining which areas have sufficient sample based on detected light therefrom and deriving analyte concentration from the areas determined to have sufficient sample, where areas determined not to have sufficient sample are not used in the derivation. Also provided are kits for use in practicing the subject methods.

Claims

1. An apparatus configured for receiving a test strip and for determining the concentration of at least one analyte in a physiological sample applied to the test strip, said apparatus comprising:

(a) at least one light source for irradiating a plurality of different areas of said test strip that has been operatively associated with said apparatus;

(b) a detector array for detecting reflected light from each of said plurality of different areas, respectively;

(c) means for determining whether each area of said plurality of different areas has a sufficient amount or sample based on said detected reflected light from each respective area; and

(d) means for determining the concentration of at least one analyte based on said reflected light detected from those areas determined to have a sufficient amount of sample, wherein areas determined not to have a sufficient amount of sample are not used in said analyte concentration determination.

2. The apparatus according to claim 1, wherein said at least one light source is capable of emitting light in the wavelength from about 400 nm to about 1000 nm.

3. The apparatus according to claim 2, wherein said light source is capable of emitting light of at least two different wavelengths.

4. The apparatus according to claim 3, wherein a first wavelength of light is about 660 nm and a second wavelength of light is about 940 nm.

5. The apparatus according to claim 1, wherein from about 4 to about 1,000 detectors comprise said detector array.

6. The apparatus according to claim 1, wherein about 1,000 detectors or more comprise said detector array.

7. The apparatus according to claim 1, further comprising imaging optics for imaging reflected light from said plurality of areas onto respective detectors of said detector array.

8. The apparatus according to claim 1, further comprising means for calibrating said apparatus.

9. The apparatus according to claim 1, further comprising means for determining the total volume of sample applied to said test strip.

10. A kit for determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) an apparatus according to claim 1; and

(b) instruction for using said apparatus for determining the concentration of at least one analyte in a physiological sample.

11. The kit according to claim 10, further comprising at least one test strip.

12. The kit according to claim 10, further comprising at least one of an element for obtaining sample and control solution.

13. A method for determining the concentration of at least one analyte in a physiological sample applied to a test strip, said method comprising:

(a) illuminating a plurality of different areas of said test strip having physiological sample applied thereto;

(b) obtaining a respective reflectance value from each area of said plurality of different areas;

(c) determining whether each area of said plurality of different areas has a sufficient amount of sample based on said obtained respective reflectance value;

(d) deriving the concentration of said at least one analyte in said physiological sample from each of said plurality of different areas determined to have a sufficient amount of sample, wherein areas determined not to have a sufficient amount of sample are not used in said derivation.

14. The method according to claim 13, wherein said step of determining comprises determining the minimum reflectance value from amongst each of said obtained reflectance values and comparing each of said obtained reflectance values to said minimum reflectance value, whereby an area is determined to have a sufficient amount of sample if it produces said minimum reflectance value or produces a reflectance value that is substantially the same as said minimum reflectance value.

15. The method according to claim 13, wherein said step of determining comprises determining a drop in reflectance for each of said plurality of areas from a time prior to sample application to a time after sample application and comparing said drop in reflectance to a predetermined drop in reflectance value, whereby an area is determined to have a sufficient amount of sample if is produces a drop in reflectance equal to or greater than said predetermined drop in reflectance value.

16. The method according to claim 15, further comprising determining if all areas adjacent an area determined to have said drop in reflectance equal to or greater than said predetermined drop in reflectance value also have a minimum drop in reflectance.

17. The method according to claim 13, wherein said step of determining comprises determining whether each of said obtained reflectance values is substantially the same as a predetermined reflectance value and at least one of:

(a) determining the minimum reflectance value from amongst each of said obtained reflectance values and comparing each of said obtained reflectance values to said minimum reflectance value, (b) determining a drop in reflectance from a time prior to sample application to a time after sample application and comparing said drop in reflectance to a predetermined drop in reflectance value, and (c) determining if all areas adjacent an area determined to have said drop in reflectance equal to or greater than said predetermined drop in reflectance value also have a minimum drop in reflectance.

18. The method according to claim 13, wherein said step of obtaining comprises providing a detector array comprised of a plurality of detectors, wherein each detector of said detector array obtains said reflectance value from a respective area of said test strip.

19. The method according to claim 18, further comprising calibrating each of said detectors separately.

20. The method according to claim 13, further comprising determining the total volume of sample applied to said test strip.

21. The method according to claim 20, wherein said step of determining total sample volume comprises computing the number of areas on the test strip determined to have a sufficient amount of sample.

22. The method according to claim 13, wherein said physiological sample is blood.