System for the optical identification of coding on a diagnostic test strip

• US 5,945,341 A
• Filed: 10/21/1996
• Issued: 08/31/1999
• Est. Priority Date: 10/21/1996
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Howard, Willis E. III
• Primary Examiner(s): Kemmerer, Elizabeth
• Assistant Examiner(s): Romeo, David S.
• Application Number:
  US08/734,103
• Time in Patent Office: 1,044 Days
• Field of Search: 436/46, 436/50, 422/58
• US Class Current: 436/46
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00752 bar codes
• 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: G06K 19/06018 one-dimensional coding
• CPC Class Codes: G06K 2019/06225 using wavelength selection, e.g. colour code
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/115831 Condition or time responsive

Abstract

Disclosed is an automated method for reading a test strip for the analysis of one or more analyte in a liquid test sample. The method involves the spectrophotometric reading of a test strip which bears at least two marker fields on its surface which are capable of reflecting light at different spectral regions from each other. The reading means of the spectrophotometer is programmed to discern information concerning the strip, such as what analyte the strip is designed to detect, from the sequences of spectral classifications by spectral reflectancy measurements of the strip'"'"'s marker fields.

Claims

1. An automated method of reading a test strip for the analysis of one or more analyte(s) in a liquid test sample which comprises the steps of:

a) providing a test strip having at least one test field on its surface which reflects light at a specific range of wavelengths and at least two distinct marker fields on the same side of its surface as the test field which marker fields reflect light at different ranges of wavelengths from each other and from the test field in a coded sequence of ranges of wavelengths which coded sequence correlates to information concerning identification of the test strip;

b) introducing the test strip into a strip reading device equipped with reading means for both of the test and marker fields which reading means comprises a light source as transmitter and a light sensitive element as receiver which receiver is capable of differentiating between the ranges of wavelengths at which the marker and test fields reflect, which strip reading device is also equipped with means for correlating the coded range of wavelength sequence of reflected light with preprogrammed information concerning the test strip which correlating means is in operative communication with the receiving means and which reading device has means for moving the strip and receiving means relative to one another, so that the reflectance of the test field and marker fields can be individually read by the reading means;

c) allowing range of wavelength values reflected by the test and marker fields to be individually read by the reading means; and

d) allowing the reading means to communicate the sequence of spectral reflectance values reflected from the marker fields to the correlating means and allowing the correlating means to correlate the sequence of reflected range of wavelength values with the preprogrammed information concerning the strip.

2. The method of claim 1 wherein the range of wavelength value reflected from the test and marker fields are read by moving the strip and reading means relative to each other.

3. The method of claim 2 wherein the strip reading device has a specimen table which is movable in relation to the reading means and wherein the strip is placed on the specimen table and moved relative to the reading means, so that the reading means can scan the marker fields.

4. The method of claim 3 wherein the strip is moved relative to the reading means a sufficient distance for the reading means to also scan the test field.

5. The method of claim 1 wherein the reading means is capable of acquiring spatial and spectral reflectances across the length of the strip.

6. The method of claim 1 wherein the information concerning the test strip is calibration information based on the particular batch from which the strip was obtained.

7. The method of claim 1 wherein the information concerning the test strip relates to which analyte or analytes the test strip is designed to analyze.

8. The method of claim 1 wherein the information concerning the test strip relates to location of reactive areas, critical times, strip age and strip reactivity.

9. The method of claim 1 in which the marker fields comprise bars which are substantially parallel to each other and are substantially perpendicular to the longitudinal axis of the strip.

10. A test strip for the analysis of one or more analytes in a fluid test sample which comprises:

a) a carrier of an absorbant material;

b) at least one test field on the surface of the carrier including at least one test field material reactive with the analyte or analytes being analyzed and capable of providing a spectrally detectable response;

c) at least two distinct marker fields on the same side of the surface of the carrier as the test field each of which marker fields having the same width as each other and being capable of reflecting light at different specific ranges of wavelengths from each other which specific ranges of wavelengths are predetermined to form a coded sequence of spectral regions which sequence correlates to information concerning identification of the test strip.

11. The strip of claim 10 wherein the absorbent material carrier is elongated.

12. The strip of claim 11 wherein the marker fields comprise bars which are substantially parallel to each other and are substantially parallel to the longitudinal axis of the strip.

13. The strip of claim 10 wherein the absorbant material is made of a material which allows the analyte and labeled antibodies specific thereto to flow through it along with the fluid test sample and to form analyte/labeled antibody conjugates which can be captured in a specific capture zone of the strip.

14. The strip of claim 10 which has four marker fields which are red, green, blue and either black or white in color.

15. The strip of claim 10 wherein at least one of the marker fields reflects in the infrared region of the spectrum.

16. The strip of claim 10 wherein the information concerning the strip to which the sequence of spectral regions correlates is the analyte for which the strip is designed to test, location of reflecting areas on the strip, critical times for reading the strip, the strip'"'"'s age or the strip'"'"'s reactivity.

17. The strip of claim 16 wherein the information relates to the analyte for which the strip is designed to test.

18. The strip of claim 10 wherein the information concerning the strip is calibration information which relates to the production batch from which the strip was obtained.

19. The strip of claim 10 which contains a control region which will generate a specific color if proper procedure for using the strip are followed.

20. A strip for the analysis of an analyte in urine which comprises:

a) an elongated carrier of an absorbant material which allows the analyte and labeled antibodies specific thereto to flow through it along with the urine and to form analyte/labeled antibody conjugates which can be captured in a specific capture zone of the strip;

b) a test field on the surface of the carrier which captures either the labeled antibody or the analyte/labeled antibody conjugate and is capable of providing a spectrally detectable response;

c) at least two distinct marker fields on the same side of the surface of the carrier as the test field in the form of bars which have the same width as each other and which marker fields are capable of reflecting light at a range of wavelengths different from the other which range of wavelengths are predetermined to form a coded sequence of range of wavelengths which sequence correlates to the analyte for which the strip is designed to test.

21. A test strip for the analysis of one or more analytes in a fluid test sample which comprises:

a) a carrier of an absorbant material;

b) at least one test field on the surface of the carrier including at least one test field material reactive with the analyte or analytes being analyzed and capable of providing a spectrally detectable response;

c) at least two distinct marker fields on the same side of the surface of the carrier as the test field each of which marker fields being capable of reflecting light at different specific ranges of wavelengths from each other which specific ranges of wavelengths are predetermined to form a coded sequence of ranges of wavelengths which sequence correlates to information concerning identification of the test strip and wherein at least one of the marker fields is white and which white marker field(s) correlates to the strip being a traditional dry chemistry strip.