Method for adding an apparent non-signal line to a lateral flow assay

• US 6,855,561 B2
• Filed: 09/10/2001
• Issued: 02/15/2005
• Est. Priority Date: 09/10/2001
• Status: Expired due to Term

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Jerome, Jeremy, Jacono, Bruce, Daquipa, Mark, Boehringer, Hans
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/950,366
• Publication Number:
  US 20030049167A1
• Time in Patent Office: 1,254 Days
• Field of Search: 436/169, 436/172, 436/175, 436/530, 436/533, 436/807, 436/823, 436/514, 436/518, 436/170, 435/287.7, 435/287.9, 435/805, 422 56- 60
• US Class Current: 436/514
• 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 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• 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 435/823 Acetobacter
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• 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 436/25125 Digestion or removing interfering materials

Abstract

A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (−) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (−) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Claims

1. A test device for determining the presence or absence of an analyte in a fluid sample, the test device comprising:

a) a solid support;

b) an intermediate piece bearing a mark thereon;

c) a matrix defining an axial flow path, the matrix comprising;

i) a sample receiving zone, at an upstream end of the flow path, that receives the fluid sample,

ii) a label zone, on the flow path downstream from the sample receiving zone, comprising a label reagent that binds with the analyte in the fluid sample flowing through the label zone, and

iii) an observation area, on the flow path downstream from the label zone, the observation area comprising a defined capture zone having an immobilized capture reagent that restrains the analyte, wherein the observation area comprises a material that is opaque in a dry state and transparent in a moist state and the mark on the intermediate piece is visible through the observation area when the observation area is in the moist state;

wherein the intermediate piece is disposed between the matrix and the support,

iv) the mark has a shape such that, in the absence of the analyte in the sample, a first symbol is displayed to represent a negative result, and

v) the capture zone has a shape such that, in the presence of analyte in the sample and taken together with the first symbol, a second symbol is formed to represent a positive result.

2. The test device of claim 1, wherein the first symbol is in the shape of a minus symbol and the second symbol is in the shape of a plus symbol.

3. The test device of claim 2, wherein the longitudinal axis of the mark is in the direction of the sample flow, and the longitudinal axis of the capture zone is perpendicular to the direction of the sample flow.

4. The device of claim 1, wherein the first symbol is a logo.

5. The test device of claim 1, wherein the first symbol comprises one or more predefined symbols.

6. The test device of claim 1, wherein the observation area further comprises a negative control area.

7. The test device of claim 1, wherein the observation area further comprises a positive control area.

8. The test device of claim 1, further comprising a hollow casing having a sample application aperture and an observation port, wherein the matrix is contained within the hollow casing, the sample is applied to the matrix through the aperture, and the observation area can be observed through the port.

9. The test device of claim 8, wherein the observation port is covered by a transparent covering.

10. A method of manufacturing the test device of claim 1, the method comprising:

a) providing a solid support;

b) providing an intermediate piece bearing a mark thereon;

c) providing a matrix defining an axial flow path, wherein the matrix comprises;

i) a sample receiving zone, at an upstream end of the flow path, that receives the fluid sample,

ii) a label zone, on the flow path downstream from the sample receiving zone, comprising a label reagent that binds with the analyte in the fluid sample flowing through the label zone, and

iii) an observation area, on the flow path downstream from the label zone, the observation area comprising a capture zone having an immobilized capture reagent that restrains the analyte, and wherein the observation area comprises a material that is opaque in a dry state and transparent in a moist state and the mark on the intermediate piece is visible through the observation area when the observation area is in the moist state and;

d) assembling the test device such that the intermediate piece is disposed between the matrix and the solid support.

11. A test device for determining the presence or absence of an analyte in a fluid sample, the test device comprising:

a) a solid support;

b) an intermediate piece bearing a mark thereon;

c) a matrix defining an axial flow path, the matrix comprising;

i) a sample receiving zone, at an upstream end of the flow path, that receives the fluid sample,

ii) a label zone, on the flow path downstream from the sample receiving zone, comprising a label reagent that binds with the analyte in the fluid sample flowing through the label zone, and

iii) an observation area, on the flow path downstream from the label zone, the observation area comprising a defined capture zone having an immobilized capture reagent that restrains the analyte, wherein the observation area comprises a material that is opaque in a dry state and transparent in a moist state and the mark on the intermediate piece is visible through the observation area when the observation area is in the moist state, wherein the intermediate piece is disposed between the matrix and the support, and

iv) the mark has a shape such that, in the presence or absence of the analyte in the sample, a first symbol is displayed, and

v) the capture zone has a shape such that, independent of the first symbol, in the presence of the analyte in the sample, a second symbol is formed to represent a positive result.

12. The test device of claim 11, wherein the first symbol is a logo.

13. The test device of claim 11, wherein the first symbol comprises one or more predefined symbols.

14. The test device of claim 11, wherein the observation area further comprises a negative control area.

15. The test device of claim 11, wherein the observation area further comprises a positive control area.

16. The test device of claim 11, further comprising a hollow casing having a sample application aperture and an observation port, wherein the matrix is contained within the hollow casing, the sample is applied to the matrix through the aperture, and the observation area can be observed through the port.

17. The test device of claim 16, wherein the observation port is covered by a transparent covering.

18. A method of manufacturing the test device of claim 11, the method comprising:

a) providing a solid support;

b) providing an intermediate piece bearing a mark thereon;

c) providing a matrix defining an axial flow path, wherein the matrix comprises;

i) a sample receiving zone, at an upstream end of the flow path, that receives the fluid sample,

ii) a label zone, on the flow path downstream from the sample receiving zone, comprising a label reagent that binds with the analyte in the fluid sample flowing through the label zone, and

iii) an observation area, on the flow path downstream from the label zone, the observation area comprising a capture zone having an immobilized capture reagent that restrains the analyte, and wherein the observation area comprises a material that is opaque in a dry state and transparent in a moist state and the mark on the intermediate piece is visible through the observation area when the observation area is in the moist state; and

d) assembling the test device such that the intermediate piece is disposed between the matrix and the solid support.