NON-VISIBLE DETECTABLE MARKING FOR MEDICAL DIAGNOSTICS

• US 20110111522A1
• Filed: 08/27/2008
• Published: 05/12/2011
• Est. Priority Date: 08/30/2007
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Profitt, James A., Zimmerie, Chris T., Pugia, Michael J.
• Granted Patent: US 9,439,630 B2
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/00772 mechanical or optical code other than bar code
• 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: G01N 35/00732 Identification of carriers, materials or components in automatic analysers

Abstract

Sample media for the analysis of analytes in a fluid test sample includes a carrier, at least one test field on the surface of the carrier including at least one reagent reactive with the analytes and capable of providing a detectable response. A non-visible bar code formed by at least two distinct non-visible marker fields is located on the carrier. The marker fields are configured to reflect electro-magnetic (EM) radiation within one or more ranges of non-visible wavelengths to form a coded sequence of reflectances correlated to identification of the sample media.

Claims

1. Sample media for the analysis of one or more analytes in a fluid test sample which comprises:

a carrier;

at least one test field on the surface of the carrier including at least one reagent reactive with the one or more analytes and capable of providing a detectable response;

a non-visible bar code formed by at least two distinct non-visible marker fields disposed on the carrier, the non-visible marker fields configured to reflect electro-magnetic (EM) radiation within one or more ranges of non-visible wavelengths to form a coded sequence of reflectances which sequence correlates to information concerning identification of the sample media.

2. The sample media of claim 1, wherein the non-visible marker fields are configured to reflect EM radiation at mutually distinct ranges of wavelengths from one another.

3. The sample media of claim 1, wherein the carrier is elongated and comprises an absorbent material configured to allow 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 thereof.

4. The sample media of claim 3, wherein the at least one test field is configured to capture either the labeled antibody or the analyte/labeled antibody conjugate and to provide a spectrally detectable response.

5. The sample media of claim 1, wherein the reagent composition is capable of interacting with a predetermined analyte to provide a spectrally detectable response.

6. The sample media of claim 1, wherein the non-visible bar code comprises an infrared (IR) barcode formed by at least two distinct IR marker fields disposed on the carrier, the marker fields configured to reflect EM radiation at ranges of wavelengths within the IR spectrum.

7. The sample media of claim 6, wherein the IR marker fields are configured to reflect wavelengths within the IR spectrum which are mutually distinct from one another.

8. The sample media of claim 1, comprising a visible bar code formed by at least two distinct visible marker fields disposed on the carrier, the visible marker fields being configured to reflect EM radiation at ranges of wavelengths in the visible light spectrum and predetermined to form a coded sequence of reflectances which sequence correlates to other information concerning identification of the sample media.

9. The sample media of claim 8, wherein the visible marker fields are configured to reflect EM radiation at ranges of wavelengths that are mutually distinct from one another.

10. The sample media of claim 8, wherein the non-visible bar code is disposed adjacent the visible bar code.

11. The sample media of claim 8, wherein the non-visible bar code is superposed with at least one of the visible bar code and the test field.

12. The sample media of claim 8 wherein at least the non-visible marker fields are sized and shaped to form a one-dimensional pattern on the carrier.

13. The sample media of claim 8 wherein at least the non-visible marker fields are sized and shaped to form a two-dimensional pattern on the carrier.

14. The sample media of claim 8 wherein at least one marker field of the visible bar code reflects in the non-visible region of the spectrum.

15. The sample media of claim 8 wherein at least one of the information and other information, is selected from the group consisting of the analyte for which the sample media is designed to test, location of reflecting areas on the media, the media'"'"'s age, the media'"'"'s reactivity, and combinations thereof.

16. The sample media of claim 15 wherein at least one of the information and other information relates to the analyte for which the media is intended to test.

17. The sample media of claim 8 wherein at least one of the information and other information comprises production batch information from which the sample media was obtained, and calibration information which relates thereto.

18. The sample media of claim 6, wherein the infrared dye is configured to reflect light in the spectrum of wavelengths greater than about 750 nm.

19. The sample media of claim 18, wherein the infrared dye is configured to reflect light in the spectrum of wavelengths greater than about 800 nm.

20. The sample media of claim 6 wherein about 0.05 to about 0.3 micrograms of the infrared dye are positioned on the sample media.

21. The sample media of claim 6 wherein the infrared dye absorbs infrared radiation at least at one infrared wavelength.

22. The sample media of claim 21 wherein the infrared dye lacks a visible color.

23. The sample media of claim 6 wherein the infrared dye is selected from the group consisting of:

5,5′

-dichloro-11-diphenylamino-3,3′

-diethyl-10,12-ethylenethiatricarbocyanine perchlorate;

3-(5-carboxypentyl)-2-[2-[3[[3-(5-carboxypentyl)-1,3-dihydro-1,1-dimethyl-2H-benz[e]indol-2-ylidene]-ethylidene]-2-(2-sulfoethylthio)-1-cyclohexene-1-yl]ethenyl]1,1-dimethyl-1H-benz[e]indolinium;

3-(5-carboxypentyl)-2-[2-[3-[[3-(5-carboxypentyl)-1,3-dihydro-1,1-dimethyl-2H-benz[e]indol-2-ylidene]-ethylidene]-2-(n-hexylthio)-1-cyclohexen-1-yl]-ethenyl]-1,1-dimethyl-1H-benz[e]indolium;

copper (II) 5,9,14,18,23,27,32,36-octabutoxy-2,3-naphthalocyanine;

5,9,14,18,23,27,32,36-octabutoxy-2,3-naphthalocyanine;

IR-165 (N,N,N¹,N¹-tetrakis (p-dibutylaminophenyl)-p-benzoquinone bisaminium hexafluoroantimonate); and

mixtures and combinations thereof.

24. The sample media of claim 1, selected from the group consisting of test strips, cards, reels, immuno-assay cassettes, and microfluidic devices.

25. Sample media for the analysis of one or more analytes in a fluid test sample which comprises:

a carrier;

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

a first bar code formed by at least two distinct marker fields disposed on the carrier, the marker fields configured to reflect light within a range of visible wavelengths to form a coded sequence of reflectances which correlate to information concerning identification of the sample media;

a second bar code formed by at least two distinct other marker fields disposed on the carrier, the other marker fields configured to reflect light within a range of wavelengths in the infrared spectrum to form a coded sequence of reflectances which correlate to other information concerning identification of the sample media.

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

a) providing sample media having at least one test field on its surface which reflects light within a specific range of wavelengths, a first bar code formed by at least two distinct marker fields which reflect light within a range of visible wavelengths in a coded sequence which correlates to information concerning identification of the sample media, and a second bar code formed by at least two distinct other marker fields, which reflect light within a range of wavelengths in the infrared spectrum to form a coded sequence which correlates to other information concerning identification of the sample media;

b) introducing the sample media into a reading device configured to read the test fields, marker fields, and other marker fields, including a light sensitive element capable of receiving and differentiating between the ranges of wavelengths at which the marker, other marker, and test fields reflect;

c) reading the range of wavelength values reflected by the test, marker, and other marker fields; and

d) correlating the sequence of reflected range of wavelength values with predetermined information concerning the sample media.