Test carrier and method for the analytical determination of components of body fluids

• US 5,104,811 A
• Filed: 12/18/1987
• Issued: 04/14/1992
• Est. Priority Date: 12/19/1986
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Lorenz, Robert, Knappe, Wolfgang-Reinhold, Skarstedt, Mark T., Sojka, Bernward, Berger, Dieter, Grage, Henry M. Jr., Bleisteiner, Manfred
• Primary Examiner(s): Lacey, David L.
• Assistant Examiner(s): REDDING, DAVID A
• Application Number:
  US07/134,950
• Time in Patent Office: 1,579 Days
• Field of Search: 422/56, 422/57, 422/58, 427/2, 436/514, 436/810, 436/164, 435/805, 435/810
• US Class Current: 436/164
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• 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 436/81 Tube, bottle, or dipstick

Abstract

On a carrier layer there are arranged several test layers which are at least partly in fluid contact with one another, enabling liquid exchange. On the carrier layer are arranged an application zone, a detection zone for the production of a detectable signal characteristic of the analytical determination, which contains at least one said test layer which is a reaction layer, and an absorption zone with a test layer which is an absorptive layer of an absorbent material, wherein the reaction layer and absorption zone are positioned next to each other. Between the application and the absorption zone is a capillary-active transport path on the carrier layer which connects the application zone and the absorption zone. The reaction layer is arranged parallel to the transport path between the application zone and the absorption zone in such a manner that it is in liquid contact with a liquid transported in the transport path. The absorption zone therefore absorbs excess liquid and permits dosing the reaction layer with a reproducible amount of sample.

Claims

1. Test carrier for determination of a component of a fluid sample, said carrier comprising a carrier layer and being divided longitudinally into a plurality of zones, said zones comprising:

(a) an application zone on said carrier layer for application of said fluid sample, said application zone comprising means for receiving said fluid sample;

(b) a detection zone on said carrier layer, said detection zone containing a reaction layer which comprises means for producing a detectable signal indicating the presence of said component;

(c) an absorption zone on said carrier layer and containing an absorptive layer, wherein said absorption zone and detection zone are positioned next to each other on said carrier layer said absorptive layer comprising material having absorptive power, said reaction layer comprising material having absorptive power greater than the absorptive power of the material of said absorptive layer; and

(d) capillary action transport means connecting said application zone and said absorption zone in flow communication said transport means and reaction layer positioned parallel to and in liquid contact with each other at a point between said application zone and said absorption zone so as to permit contact with said fluid sample by both said transport means and said reaction layer.

2. Test carrier of claim 1, wherein said capillary action transport means comprises material having absorptive power and said absorption zone comprises material having an absorptive power greater than the absorption power of said material in said transport means.

3. Test carrier of claim 1, wherein said capillary action transport means comprises material having absorptive power and said reaction layer comprises material having absorptive power greater than the absorptive power of said material in said capillary action transport means.

4. Test carrier of claim 1, further comprising a liquid transport zone arranged on said carrier layer positioned between said application zone and said detection zone and in flow communication with said application and said detection zone, said capillary action transport, meons extending from said application zone through said transport zone to said detection zone.

5. Test carrier of claim 1, wherein said capillary active transport meons comprises a transport layer of fibrous material.

6. Test carrier of claim 1, wherein said capillary action transport meons comprises a slot of at least 0.05 mm width.

7. Test carrier of claim 1 further comprising a sample recognition zone positioned between said detection zone and said absorption zone and in flow communication with said detection zone and said absorption zone, which recognition zone comprises means for showing in a detectable manner that a sufficient amount of sample has been applied at said application zone.

8. The test carrier of claim 1, wherein said absorptive layer of said absorption zone and said transport means comprise materials having an absorption volume, the absorption volume of said absorptive zone being greater than the absorption volume of said transport means.

9. Test carrier of claim 6, wherein said slot is from about 0.15 to about 0.20 mm in width.

10. Method for determining a component of a fluid sample, comprising:

contacting said fluid sample with a test carrier, said test carrier comprising a carrier layer, and being divided longitudinally into a plurality of zones including an application zone on said carrier layer for application of said fluid sample, said application zone comprising means for receiving said fluid sample;

a detection zone on said carrier layer and containing a reaction layer which comprises means for producing a detectable signal indicating the presence of said component, said reaction layer comprising material having absorptive power, an absorption zone on said carrier layer and containing an absorptive layer comprising material having absorptive power, said absorptive power of said material of said reaction layer being greater than the absorptive power of the material of said absorptive layer, wherein said absorption zone and detection zone are positioned next to each other on said carrier, and a capillary action transport means on said carrier layer and connecting said application and absorption zones in flow communication with said transport means and reaction layer being positioned parallel to each other at a point between said application and absorption zones, wherein said contacting of said fluid with said test carrier permits contact of said fluid with both said transport means and reaction layer, and

(b) determining production of a detectable signal in said reaction layer as a determination of said component.

11. Method for determining a component sample as in claim 10 wherein said test carrier further comprises a sample recognition zone positioned between said detection zone and said absorption zone and in flow communication with said detection zone and absorption zone, said method comprising the additional step of determining that sufficient sample has been applied to said test carrier by measurement at the sample recognition zone.