Embossed test strip system

• US 6,162,639 A
• Filed: 12/18/1998
• Issued: 12/19/2000
• 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:
  US09/215,686
• Time in Patent Office: 732 Days
• Field of Search: 435/7.1, 435/7.9, 435/7.91-7.95, 435/28, 435/805, 435/810, 435/287.1, 435/287.3, 435/288.7, 435/970, 435/287.7-287.9, 436/518, 436/541, 436/169, 436/52, 436/805, 436/808, 436/810, 436/823, 436/164, 436/170, 436/530, 422/55, 422/56, 422/58
• US Class Current: 435/287.1
• 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 include 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 test strip comprising a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip, and a capillary tube having a collar protruding into engagement with the pillow.

2. The test strip according to claim 1 wherein the microtitration pocket is in communication with a capillary tube such that a sample is transported to the pillow in the pocket.

3. The test strip according to claim 2 wherein the capillary tube is constructed to hold a specific volume of the sample and release the specific volume sample into the pillow.

4. The test strip according to claim 1, wherein the reaction matrix layer is embossed prior to insertion into the pocket.

5. The test strip of claim 1, wherein the embossed reaction matrix layer comprises collapsed areas having a void volume of approximately zero surrounding the pillow.

6. A test strip comprising a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip, and a capillary tube constructed to hold a specific volume of the sample and release the specific volume sample into the pillow wherein the specific volume is approximately 3 μ

L.

7. The test strip of claim 6, wherein the embossed reaction matrix layer comprises collapsed areas having a void volume of approximately zero surrounding the pillow.

8. A test strip comprising:

a support member having a pocket formed therein;

an embossed test matrix layer containing a reagent, the embossed test matrix layer comprising collapsed areas having a void volume of approximately zero surrounding a small bibluous pillow, the pillow received within the pocket;

a top layer connected to the support member; and

a capillary tube in communication with the pocket constructed to transfer a sample having a specific volume to the pillow, wherein the specific volume is approximately 3 μ

L.

9. The test strip of claim 8, further comprising an embossed wicking layer received within the pocket.

10. The test strip according to claim 9, wherein the reaction matrix layer is embossed prior to insertion into the pocket.

11. A test strip comprising:

a support member having a pocket formed therein;

an embossed test matrix layer containing a reagent, the embossed test matrix layer comprising collapsed areas having a void volume of approximately zero surrounding a small bibluous pillow, the pillow received within the pocket;

a top layer connected to the support member; and

a capillary tube in communication with the pocket wherein the capillary tube includes a collar protruding from an end of the capillary tube and into engagement with the pillow.