Embossed test strip system

• US 6,455,324 B1
• Filed: 09/08/2000
• Issued: 09/24/2002
• Est. Priority Date: 12/19/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Douglas, Joel S.
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): DO, PENSEE T
• Application Number:
  US09/658,000
• Time in Patent Office: 746 Days
• Field of Search: 436/518, 436/541, 436/169, 436/52, 436/805, 436/809, 436/808, 436/810, 436/823, 435/7.1, 435/7.9, 435/7-1-, 435/28, 435/805, 435/810, 435/287.1, 435/287.3, 435/288.7, 435/970
• US Class Current: 436/518
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• 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 436/805 Optical property
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/823 Immunogenic carrier or carrier per se
• CPC Class Codes: Y10T 436/117497 with a continuously flowing sample or carrier stream

Abstract

The invention provides a method for measuring the amount of analyte in a sample of biological fluid using a simple low sample volume reagent test strip with a built in metering system. The test strip may comprise a microtitration zone to prevent oversampling and an integrated capillary to prevent problems associated with short sampling and act as means of absorbing the fluid sample. The test strip comprises a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip. The test strip is used in single use applications such as the determination of the concentration of glucose in blood.

Claims

1. A low sample volume test strip comprising:

a top layer;

a bottom layer;

a test area disposed between the top and bottom layer, the test area comprising a reaction zone having a predetermined void volume and a precompressed area surrounding the reaction zone, the precompressed area having a void volume of approximately zero; and

,

a capillary constructed to be filled with and deliver a sample to the test area.

2. The test strip of claim 1, wherein the capillary comprises a capillary tube.

3. The test strip of claim 1, wherein the test area comprises a reaction matrix.

4. The test strip of claim 3, wherein the test area further comprises a wicking layer.

5. The test strip of claim 1, wherein the capillary is constructed to be filled with and deliver a sample having a volume of about 3 μ

L to the test area.

6. A low sample volume test strip comprising:

a top layer;

a bottom layer;

a test area defining a microtitration zone of a predetermined volume disposed between the top layer and the bottom layer, the test area comprising a reaction zone having a predetermined void volume and a precompressed area surrounding the reaction zone, the precompressed area having a void volume of approximately zero; and

,

a capillary constructed to deliver a sample to the test area.

7. The test strip of claim 6, wherein the predetermined volume is about 3 μ

L.

8. The test strip of claim 6, wherein the capillary comprises a capillary tube.

9. The test strip of claim 6, wherein the test area comprises a reaction matrix.

10. The test strip of claim 9, wherein the test area further comprises a wicking layer.