Test strip

• US 5,271,895 A
• Filed: 03/18/1993
• Issued: 12/21/1993
• Est. Priority Date: 02/27/1991
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation
• Inventors: McCroskey, Ralph P., Freitag, Helmut E. C., Secrest, Stephanie, Bouse, Lee, Smith, Mary C., Dean, Kenneth J.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US08/033,451
• Time in Patent Office: 278 Days
• Field of Search: 422/56, 422/57, 422/58, 422/60, 422/61, 422/101, 436/169, 436/170, 435/7.92, 435/7.94, 435/291, 435/970, 435/975
• US Class Current: 422/408
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• 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: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

The operative site of an assay device is dosed with a controlled volume of a liquid specimen by a holding device which holds the controlled volume of specimen in contact with the operative site, although the holding device remains out of contact with the operative site. A sink device is in contact with the margin of the holding device and moves excess specimen away from the holding device. In one embodiment the device makes possible a non-wipe teststrip architecture. The device can be used in the detection of analytes including glucose or cholesterol in blood or urine and can be interrogated visually, optically or electrically, depending on the reagent used at the operative site.

Claims

1. A teststrip for use in an assay to determine the presence or concentration of analyte in a liquid specimen, the teststrip comprising;

(a) a reagent layer;

(b) a surfactant treated netting, overlaying the reagent layer, having openings of a size sufficient to pass a liquid specimen;

(c) means for maintaining the surfactant treated netting in a spaced-apart relationship with the reagent layer so as to define a space of controlled volume therebetween such that when liquid specimen is applied to the surfactant treated netting a controlled volume thereof will pass through the surfactant treated netting and be held by surface tension in substantially uniform contact with the reagent layer; and

(d) a sink means, positioned at the periphery of the surfactant treated netting, which is capable of absorbing and holding liquid specimen which is not held in the space of controlled volume.

2. A teststrip according to claim 1 wherein the reagent layer makes a detectable change in response to contact with an analyte in the specimen.

3. A teststrip according to claim 2 wherein the detectable change is in the electrical characteristics of the reagent layer.

4. A teststrip according to claim 2 wherein the detectable change is in the reflectance characteristics of the reagent layer.

5. A teststrip according to claim 1 wherein the surfactant treated netting is made of a woven polyester.

6. A teststrip according to claim 1 wherein the sink means is made from material selected from the group consisting of cellulosic materials, woven and non-woven fabrics and combinations thereof.

7. A teststrip according to claim 6 wherein the material is treated with a surfactant.

8. A teststrip according to claim 1 wherein the surfactant treated netting is at least partially covered by a filter means for separating components of the specimen prior to contact with the surfactant treated netting.

9. A teststrip according to claim 8 wherein the filter means is a glass fleece.

10. A teststrip wherein the construction of claim 1 is contained between first and second supports.

11. A teststrip according to claim 10 wherein at least one of the first and scorn supports includes a handle portion for manipulating the teststrip.

12. A teststrip wherein the construction of claim 1 is held between first and second supports, at least one of which supports is elongated to function as a handle for manipulating the teststrip, wherein the first and second supports include openings which are substantially opposite one another and which overlay at least the surfactant treated netting and the reagent layer, the opening overlying the surfactant treated netting functioning as a specimen application port and the opening overlying the reagent layer functioning as an interrogation port.

13. The teststrip of claim 1 wherein the reagent layer is supported on a transparent support.

14. The teststrip of claim 1 which additionally includes a barrier means positioned in contact with the reagent layer and the sink means so as to resist transfer of liquid sample from the sink means to the reagent layer.