Bar code readable diagnostic strip test

• US 6,770,487 B2
• Filed: 05/01/2001
• Issued: 08/03/2004
• Est. Priority Date: 05/01/2001
• Status: Expired due to Term

• Current Assignee: Ischemia Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Ischemia Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: Crosby, Peter A.
• Primary Examiner(s): Nguyen, Bao Thuy L.
• Application Number:
  US09/846,411
• Publication Number:
  US 20030124738A1
• Time in Patent Office: 1,190 Days
• Field of Search: 435/7.1, 435/2, 435/5, 435/7.21, 435/7.32, 435/239, 435/803, 435/287.2, 435/207.7, 435/805, 435/810, 435/970, 436/513, 436/512, 436/518, 436/531, 436/526, 436/806, 422/56
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property

Abstract

Diagnostic test devices, including diagnostic strip tests, are provided in which identifying information and the test result are machine-readable. Also provided are methods for obtaining identifying information and test results from the diagnostic test devices.

Claims

1. A diagnostic test device comprising:

a) a sample zone for application of a fluid sample;

b) at least one test zone having reagents necessary for performing an assay for an analyte, whereby an analyte assay result may be obtained; and

c) machine-readable information comprising identifying information and analyte assay information capable of indicating said analyte assay result said machine-readable information comprising identifying information and analyte assay information are located in the same position in said test zone;

wherein said analyte assay result is indicated by an alteration of existing machine-readable information.

2. The diagnostic test device of claim 1, wherein the machine-readable information is a bar code.

3. The diagnostic test device of claim 2, further comprising machine readable information in a plurality of locations on the test device.

4. The diagnostic test device of claim 2, wherein the bar code is a two-dimensional bar code.

5. The diagnostic test device of claim 1 further comprising more than one test zone, wherein each test zone provides the reagents necessary for performing an assay for the presence of a different analyte.

6. The diagnostic test device of claim 1 further comprising more than one test zone, wherein each test zone provides the reagents necessary for performing an assay for the presence of a different amount of analyte.

7. The diagnostic test device of claim 1, wherein the machine-readable information is printed in invisible ink.

8. The diagnostic test device of claim 1, wherein the diagnostic test device provides a visible test result.

9. The diagnostic test device of claim 1, further comprising at least one quality control zone in fluid communication with the sample zone comprising an indicator reagent for confirming the completion of the assay.

10. The diagnostic test device of claim 1, wherein the machine readable information is selected from the group consisting of MICR, OCR, a fluorophore, a chromophore, a radioisotope, a dye, colloidal gold, colloidal carbon, a latex particle, and a chemiluminescent agent.

11. A diagnostic strip test comprising at least one flow path, each flow path comprising;

a) a sample zone for application of a fluid sample;

b) at least one test zone in fluid communication with the sample zone, the test zone of each flow path having reagents necessary for performing an assay for the presence of an analyte, whereby an analyte assay result may be obtained; and

c) machine-readable information comprising identifying information and analyte assay information capable of indicating said analyte assay result, said machine-readable information comprising identifying information and analyte assay information are located in the same position in said test zone;

wherein said analyte assay result is indicated by an alteration of existing machine-readable information.

12. A method for obtaining identifying information and the analyte assay result of a diagnostic test, comprising the steps of:

a) providing a diagnostic test device comprising;

i) a sample zone for application of a fluid sample;

ii) at least one test zone having reagents necessary for performing an assay for the analyte, whereby the analyte assay result may be obtained; and

iii) machine-readable information comprising the identifying information and analyte assay information capable of indicating the analyte assay result, said machine-readable information comprising identifying information and analyte assay information are located in the same position in said test zone;

b) performing the analyte assay; and

c) machine reading the machine-readable information;

whereby the identifying information and the analyte assay result may be obtained, wherein said analyte assay result is indicated by an alteration of existing machine-readable information.

13. The method of claim 12, wherein the machine-readable information is a bar code printed on one side of a strip test.

14. The method of claim 13, wherein the bar code is linear.

15. The method of claim 13, wherein the bar code is two dimensional.

16. The method of claim 13, wherein the bar code is printed in invisible ink.

17. The method of claim 12, wherein the machine-readable information is detectable by optically scanning.

18. The method of claim 12, wherein the diagnostic test device further comprises machine readable information in a plurality of locations on the test device.

19. The method of claim 12, further comprising more than one test zone, wherein each test zone provides the reagents necessary for performing an assay for the presence of a different analyte.

20. The method of claim 12, further comprising more than one test zone, wherein each test zone provides the reagents necessary for performing an assay for the presence of a different amount of a desired analyte.

21. The method of claim 12, further comprising more than one test zone, wherein a first set of test zones provides the reagents necessary for performing an assay for the presence of one or more different analytes, and a second set of test zones provides the reagents necessary for performing an assay for the presence of a different amount of said one or more different analytes.

22. The method of claim 12, wherein the assay result is visible.

23. The method of claim 12, wherein step (c) further comprises decoding the machine-readable information and entering the identifying information and the analyte assay result in a laboratory information system.

24. The method of claim 12, wherein the diagnostic strip test further comprises at least one quality control zone in fluid communication with the sample zone comprising an indicator reagent for confirming the completion of the assay.

25. The method of claim 12, wherein the machine readable information is selected from the group consisting of MICR, OCR, a fluorophore, a chromophore, a radioisotope, a dye, colloidal gold, colloidal carbon, a latex particle, and chemiluminescent agent.

26. A method for obtaining identifying information and the analyte assay result of a diagnostic strip test, comprising the steps of:

a) providing a diagnostic strip test comprising at least one flow path, each flow path comprising;

i) a sample zone for application of a fluid sample;

ii) at least one test zone in fluid communication with the sample zone, the test zone of each flow path having reagents necessary for performing an assay for the analyte, whereby the analyte assay result may be obtained; and

iii) machine-readable information comprising the identifying information and the analyte assay information capable of indicating analyte assay result, said machine-readable identifying information and analyte assay information are located in the same position in said test zone;

b) performing the analyte assay; and

c) machine reading the machine-readable information;

whereby the diagnostic strip test identifying information and analyte assay result may be obtained;

wherein said analyte assay result is indicated by an alteration of existing machine-readable information.