Device for carrying out lateral-flow assays involving more than one analyte

• US 6,844,200 B2
• Filed: 08/06/2001
• Issued: 01/18/2005
• Est. Priority Date: 03/01/1999
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Brock, David A.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/921,497
• Publication Number:
  US 20020001818A1
• Time in Patent Office: 1,261 Days
• Field of Search: 422 55- 58, 422/61, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/805, 435/810, 435/970, 435/978, 435/7.1, 436/169, 436/514, 436/518, 436/530, 436/588, 436/805, 436/810, 436/815
• US Class Current: 436/514
• 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 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

Disclosed is an improvement to a dry assay device for determining the concentration of a first analyte in a sample of body fluid and a second analyte in the same sample of body fluid. The device involves the use of a strip of an absorbent material through which the sample of body fluid flows and wherein the first analyte is determined colorimetrically in a first region of the strip and the second analyte is determined by an immunoassay which takes place in a second region of the strip located downstream from the first region. The improvement involves placing the strip in a hollow casing having a top and a bottom and which is so constructed that when the top and bottom of the casing are mated there is formed a U shaped, body fluid impervious barrier around the first region of the strip to prevent the sample of body fluid from flowing in any direction other than in the direction of the second region of the strip.

Claims

1. A device for detecting the concentration of a target analyte in a sample of body fluid relative to the concentration of a reference analyte in the same sample of body fluid which comprises:

i. a strip of absorbent material through which the test sample can flow which strip contains;

a) a first zone which contains reagents for colorimetric determination of the reference analyte;

b) a second zone containing a releasable specific binding reagent for the target analyte which specific binding reagent bears an attached detectable label and forms an analyte/labeled specific binding partner reagent upon contact with the body fluid sample containing the target analyte; and

c) a third region which contains an immobilized capture reagent for specifically binding the analyte or labeled specific binding reagent for the analyte; and

ii. a hollow casing having a top and bottom segment enclosing the strip of absorbent material which casing has a body fluid inlet port directly above and in visual and fluid communication with the first zone of the strip of absorbent material and one or more view ports for detecting the amount of detectable label captured in the third region wherein the hollow casing has a U shaped body fluid impervious barrier which surrounds three sides of the first region of the strip thereby allowing a sample of body fluid applied to the first region of the strip through the inlet port to flow only in the direction of the second and third regions.

2. The device of claim 1 wherein the top and bottom segment are constructed so that a press fit secures them together to form the casing.

3. The device of claim 1 wherein the casing is made of plastic.

4. The device of claim 3 wherein the plastic is polystyrene, an acrylic polymer or a polyurethane.

5. The device of claim 1 wherein a portion of the U shaped barrier is embossed from the top segment of the casing and a portion is embossed from the bottom portion so that when the top and bottom portions are mated around the strip there is formed the complete “

U”

shaped barrier.

6. A method for determining the relative concentrations of a first analyte and a second analyte in a sample of body fluid which method comprises applying the sample of body fluid to the strip of claim 1, and determining the response in the first zone and the response in the second zone, thereby determining the relative concentrations of a first analyte and a second analyte in a sample of body fluid, wherein said first analyte comprises said reference analyte and said second analyte comprises said target analyte, and wherein the concentration of said first analyze is clinically related to the concentration of said second analyte.

7. The method of claim 6 wherein the body fluid is urine.

8. The method of claim 7 wherein the first analyte is creatinine and the second analyte is deoxypyridinoline (Dpd).

9. The method of claim 6 wherein the second analyte'"'"'s observed concentration is corrected based on comparison to the observed concentration of the first analyte.

10. The method of claim 9 wherein the body fluid is urine, the first analyte is creatinine and the second analyte is deoxypyridinoline (Dpd).