Analytical devices with integrated desiccant

• US 8,617,486 B2
• Filed: 05/06/2013
• Issued: 12/31/2013
• Est. Priority Date: 04/20/2007
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Kirby, Kevin J., Dennison, Sarah
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US13/888,252
• Publication Number:
  US 20130244315A1
• Time in Patent Office: 239 Days
• Field of Search: 422/401, 422/412
• US Class Current: 422/412
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/105 using desiccants
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/56938 Staphylococcus
• CPC Class Codes: G01N 33/56983 Viruses

Abstract

An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.

Claims

1. A lateral flow immunoassay device for detection of an analyte in a biological sample, comprising:

an analytical test strip comprising

a support member,

a plurality of porous pads in fluid communication, said plurality of porous pads in contact with the support member and including, in sequence, a sample receiving pad, a label pad containing mobile tag reagents, a test pad containing immobilized binding reagents, and an absorbent pad which serves as a sink zone, and

a desiccant portion, comprising a film or membrane having desiccant dispersed therein, which is laminated to the analytical test strip, such that said desiccant is disposed adjacent the absorbent pad,

wherein said desiccant portion remains integral with the analytical test strip during use thereof.

2. The device of claim 1, wherein the desiccant portion is not in fluid communication with the plurality of porous pads.

3. The device of claim 1, wherein the desiccant portion comprises a material selected from the group consisting of molecular sieves and silica gel.

4. The device of claim 1, wherein the analytical test strip is in the form of a dipstick.

5. The device of claim 1, wherein said mobile tag reagents and immobilized reagents are capable of binding an influenza A analyte.

6. The device of claim 5, comprising two test lines within said test pad, containing immobilized reagents capable of binding influenza A and influenza B analytes, respectively.

7. The device of claim 1, wherein said mobile tag reagents and immobilized reagents are capable of binding a Streptococcus pyogenes analyte.

8. The device of claim 1, wherein the desiccant is integrated into the device by

(i) providing a desiccant-loaded film or membrane;

and

(ii) laminating said desiccant-loaded film or membrane to the test strip.

9. The device of claim 1, wherein the desiccant portion is positioned above at least the absorbent pad.

10. The device of claim 1, wherein the desiccant portion is positioned below at least the absorbent pad.