Apparatus and method for determination of non-hemolyzed levels of occult blood in urine

• US 5,654,803 A
• Filed: 05/09/1996
• Issued: 08/05/1997
• Est. Priority Date: 05/09/1996
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Rehm, Gary E., Howard, Willis E. III, Radtke, Marilyn
• Primary Examiner(s): Font, Frank G.
• Assistant Examiner(s): Smith, Zandra V.
• Application Number:
  US08/647,121
• Time in Patent Office: 453 Days
• Field of Search: 356/446, 422/82.05, 436/66, 436/164, 436/169
• US Class Current: 356/446
• CPC Class Codes: G01N 21/47 Scattering, i.e. diffuse reflection G01N21/25, G01N21/41 take precedence G01N21/55 takes precedence
• 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

An apparatus for analyzing a body-fluid sample disposed on a reagent pad is provided with a light bulb for successively illuminating a plurality of different portions of the reagent pad on which the body-fluid sample is disposed and a detector array for detecting light received from the reagent pad and generating a plurality of reflectance signals in response to light received from a corresponding one of the different portions of the reagent pad. The apparatus is also provided with means for determining whether the magnitude of one of the reflectance signals is substantially different than the magnitude of another of the reflectance signals. Where the body-fluid sample is urine, this capability allows the apparatus to detect the presence of non-hemolyzed in the urine sample. The light bulb may successively illuminate a plurality of overlapping portions of the reagent pad, and may successively illuminate at least three different portions of the reagent pad which are linearly offset from each other.

Claims

1. An apparatus for analyzing a urine sample disposed on a reagent pad to detect non-hemolyzed levels of occult blood in said urine sample, said apparatus comprising:

means for successively illuminating a plurality of different portions of said reagent pad on which said urine sample is disposed;

means for detecting light received from said reagent pad, said detecting means generating a plurality of reflectance signals each having a magnitude, each of said reflectance signals being generated in response to light received from a corresponding one of said different portions of said reagent pad illuminated by said illuminating means;

means for determining a difference between said magnitude of one of said reflectance signals and said magnitude of another of said reflectance signals; and

means for comparing said difference with a predetermined threshold to detect the presence of non-hemolyzed blood in said urine sample.

2. An apparatus as defined in claim 1 wherein said means for determining said difference comprises:

means for determining which of said reflectance signals has the largest magnitude;

means for determining which of said reflectance signals has the smallest magnitude; and

means for determining a difference between said largest magnitude and said smallest magnitude of said reflectance signals.

3. An apparatus as defined in claim 1 wherein said illuminating means comprises means for successively illuminating a plurality of overlapping portions of said reagent pad.

4. An apparatus as defined in claim 1 wherein said illuminating means comprises means for successively illuminating at least three different portions of said reagent pad which are linearly offset from each other.

5. An apparatus as defined in claim 1 wherein said illuminating means comprises:

a light bulb (46); and

means (220) for providing relative movement between said light bulb and said reagent pad (30).

6. An apparatus as defined in claim 5 additionally comprising a tray (20) in which said reagent pad (30) is disposed, wherein said light bulb (46) is disposed in a fixed position and wherein said means (220) for providing relative movement between said light bulb (46) and said reagent pad (30) comprises means for moving said tray.

7. An apparatus as defined in claim 1 additionally comprising means for determining whether said magnitudes of a plurality of said reflectance signals are within a predetermined range.

8. An apparatus as defined in claim 7 wherein said means for determining whether said magnitudes of a plurality of said reflectance signals are within a predetermined range comprises means for successively comparing said plurality of said reflectance signals to an upper threshold defining a first end of said range and a lower threshold defining a second end of said range.

9. An apparatus for analyzing a body-fluid sample disposed on a reagent pad, said apparatus comprising:

means for successively illuminating a plurality of different portions of said reagent pad on which said body-fluid sample is disposed;

means for detecting light received from said reagent pad, said detecting means generating a plurality of reflectance signals each having a magnitude, each of said reflectance signals being generated in response to light received from a corresponding one of said different portions of said reagent pad illuminated by said illuminating means; and

means for determining whether said magnitude of one of said reflectance signals is substantially different than said magnitude of another of said reflectance signals.

10. An apparatus as defined in claim 9 additionally comprising:

means for determining a decode signal based upon said reflectance signals; and

means comparing said decode signal with a plurality of predetermined thresholds to categorize said body-fluid sample.

11. An apparatus as defined in claim 10 wherein said means for determining a decode signal comprises means for selecting one of said reflectance signals as said decode signal.

12. An apparatus as defined in claim 10 wherein said means for determining a decode signal comprises means for determining said decode signal based on an average of a plurality of said reflectance signals.

13. An apparatus as defined in claim 9 wherein said illuminating means comprises means for successively illuminating a plurality of overlapping portions of said reagent pad.

14. An apparatus as defined in claim 9 wherein said illuminating means comprises means for successively illuminating at least three different portions of said reagent pad which are linearly offset from each other.

15. A method of analyzing a urine sample disposed on a reagent pad, said method comprising the steps of:

(a) illuminating a first portion of said reagent pad;

(b) detecting light received from said first portion of said reagent pad;

(c) generating a first reflectance signal having a magnitude based on said light detected during said step (b);

(d) illuminating a second portion of said reagent pad, said second portion being different from said first portion;

(e) detecting light received from said second portion of said reagent pad;

(f) generating a second reflectance signal having a magnitude based on said light detected during said step (e); and

(g) determining whether said magnitude of said first reflectance signal is substantially different than said magnitude of said second reflectance signal.

16. A method as defined in claim 15 wherein said step (g) comprises the steps of:

(g1) determining a difference between said magnitude of said first reflectance signal and said magnitude of said second reflectance signal; and

(g2) comparing said difference with a threshold to determine whether said difference is greater than said threshold.

17. A method as defined in claim 15 wherein said step (d) comprises the step of illuminating a portion of said reagent pad that overlaps said first portion of said reagent pad.

18. A method as defined in claim 15 wherein said step (g) comprises the steps of:

(h) determining a decode signal based upon said reflectance signals; and

(i) comparing said decode signal with a plurality of predetermined thresholds to categorize said urine sample.

19. An apparatus for illuminating a body-fluid sample disposed on a reagent pad, said reagent pad having an overall area, said apparatus comprising:

means for illuminating a first portion of said reagent pad on which said body-fluid sample is disposed, said first portion of said reagent pad having an area that is smaller than said overall area of said reagent pad;

means for moving said reagent pad relative to said illuminating means so that said illuminating means illuminates a second portion of said reagent pad different from said first portion of said reagent pad, said second portion of said reagent pad having an area that is smaller than said overall area of said reagent pad; and

means for detecting light received from said illuminated portions of said reagent pad.

20. An apparatus as defined in claim 19 wherein said illuminating means comprises a light bulb and a wall portion disposed between said light bulb and said reagent pad, said wall portion having an aperture positioned to be illuminated by said light bulb so that light which passes through said aperture illuminates said first and second portions of said reagent pad.

21. An apparatus as defined in claim 19 wherein said illuminating means comprises means for successively illuminating a plurality of overlapping portions of said reagent pad.

22. An apparatus as defined in claim 19 wherein said illuminating means comprises means for successively illuminating at least three different portions of said reagent pad which are linearly offset from each other.