Test strip for the assay of an analyte in a liquid sample

• US 6,316,264 B1
• Filed: 12/17/1999
• Issued: 11/13/2001
• Est. Priority Date: 12/17/1999
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Pugia, Michael J., Rehm, Gary E., Corey, Paul F.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Siefke, Samuel P.
• Application Number:
  US09/466,637
• Time in Patent Office: 697 Days
• Field of Search: 436/519, 436/110, 436/66, 436/164, 436/169, 252/408.1, 422/58, 422/64, 422/56, 422/57, 435/4
• US Class Current: 436/66
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10T 436/173076 Nitrite or nitrate

Abstract

An improved test strip for determining the presence or concentration of unknown or a constituent in a liquid test sample is disclosed. The test strip comprises a support strip and a test pad, wherein the test pad includes a carrier matrix incorporating a reagent composition capable of interacting with the constituent of interest to produce a detectable or measurable response. The test strip further comprises an infrared dye, applied either to the support strip or incorporated into a test pad, which ensures proper alignment of the test strip in an apparatus having a detection system for the detectable or measurable response. The improved test strip reduces the number of erroneous assays for the constituent of interest.

Claims

1. A test strip for determining the presence or concentration of one or more predetermined analytes in a liquid test sample comprising:

(a) a support handle;

(b) one or more test pads positioned on the support handle, each test pad comprising (i) a carrier matrix incorporating (ii) a reagent composition capable of interacting with a predetermined analyte to provide a detectable response; and

(c) an infrared dye positioned at a predetermined location on the test strip.

2. The test strip of claim 1 wherein about 0.05 to about 0.3 micrograms of the infrared dye are positioned on the test strip.

3. The test strip of claim 1 wherein the infrared dye is positioned on the support handle of the test strip.

4. The test strip of claim 1 wherein the infrared dye is incorporated into one or more test pad.

5. The test strip of claim 1 wherein the infrared dye is incorporated into one or more test pad and positioned on the support handle of the test strip.

6. The test strip of claim 1 wherein the infrared dye absorbs infrared radiation at least at one infrared wavelength.

7. The test strip of claim 6 wherein the infrared dye lacks a visible color.

8. The test strip of claim 1 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)-l-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, and mixtures thereof.

9. The test strip of claim 1 wherein the infrared dye is incorporated into a test pad capable of assaying for nitrite or for occult blood.

10. The test strip of claim 1 wherein the infrared dye is applied to the support handle and is positioned adjacent to a test pad capable of assaying for nitrite.

11. A method of monitoring alignment of a test strip in an optical pathway of a detection apparatus comprising:

(a) providing a test strip, said test strip comprising

(i) a support handle;

(ii) one or more test pads positioned on the support handle, each test pad comprising (i) a carrier matrix incorporating (ii) a reagent composition capable of interacting with a predetermined analyte to provide a detectable response; and

(iii) an infrared dye positioned at a predetermined location on the test strip;

(b) inserting the test strip in the detection apparatus;

(c) illuminating the predetermined location of the infrared dye on the test strip with infrared radiation;

(d) measuring a reflectance of infrared radiation from the predetermined location on the test strip; and

(e) correlating the reflectance measurement to the alignment of the test strip in the detection apparatus.

12. The method of claim 11 wherein the detection apparatus is a scanning-type apparatus.

13. The method of claim 11 wherein the detection apparatus is a camera-type apparatus.

14. The method of claim 11 wherein the test strip is rejected by the detection apparatus when misaligned by about 0.05 inch or greater.

15. The method of claim 11 wherein misalignment of the test strip in the detection apparatus by an amount of 0.030 inch or greater is detected.