Immunoassay device with improved sample closure

• US 8,377,392 B2
• Filed: 06/08/2012
• Issued: 02/19/2013
• Est. Priority Date: 09/10/2003
• Status: Expired due to Fees

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Miller, Cary James, Maczuszenko, Andy
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US13/492,089
• Publication Number:
  US 20120252032A1
• Time in Patent Office: 256 Days
• Field of Search: 422/501, 422/505, 422/425, 422/430, 436/63, 436/66, 436/180
• US Class Current: 422/505
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/046 Chemical or electrochemical formation of bubbles
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: Y10T 436/25 : including sample preparation
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

An apparatus and method for sealing a fluid sample collection device, comprising loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop.

Claims

1. A device configured to receive whole-blood, comprising:

a housing comprising an orifice that is in fluid communication with a conduit that terminates at an internal capillary stop; and

a pump configured to displace the whole-blood throughout the device,

wherein at least a portion of the conduit is corona-treated and at least a portion of the conduit is coated with a dry reagent mixture comprising at least a water-soluble protein and a polymer containing hydroxyl groups, whereby individual drops of the whole-blood form a contiguous segment of the whole-blood in the conduit.

2. The device of claim 1, wherein the pump is further configured to displace the whole-blood past the internal capillary stop.

3. The device of claim 2, wherein the pump is an airbladder.

4. The device of claim 1, wherein the pump is further configured to dissolve and concentrate the dry reagent mixture in the contiguous segment of the whole-blood.

5. The device of claim 4, wherein the pump is an airbladder.

6. The device of claim 1, wherein at least a portion of the conduit is coated with a dry reagent composition comprising an additive selected from the group consisting of:

goat IgG, mouse IgG, heparin, dextran, Tris buffer, proclin, and sodium chloride in a support matrix.

7. The device of claim 6, wherein the support matrix is cellulose, polyvinyl alcohol, gelatin, or mixtures thereof.

8. The device of claim 6, wherein the dry reagent composition is located on at least the portion of the conduit such that the dry reagent composition is introduced to the contiguous segment of the whole-blood prior to a whole-blood immunoassay.

9. The device of claim 8, wherein the pump is further configured to dissolve and concentrate the dry reagent composition in the contiguous segment of the whole-blood.

10. The device of claim 1, wherein at least a portion of the conduit is coated with a dry reagent composition comprising an additive selected from the group consisting of:

dextran and sodium chloride in a support matrix.

11. The device of claim 10, wherein the support matrix is cellulose, polyvinyl alcohol, gelatin, or mixtures thereof.

12. The device of claim 10, wherein the dry reagent composition is located on at least the portion of the conduit such that the dry reagent composition is introduced to the contiguous segment of the whole-blood prior to a whole-blood immunoassay.

13. The device of claim 12, wherein the pump is further configured to dissolve and concentrate the dry reagent composition in the contiguous segment of the whole-blood.

14. The device of claim 1, wherein the dry reagent mixture further comprises bovine serum albumin (BSA).

15. The device of claim 1, wherein the dry reagent mixture further comprises bovine serum albumin (BSA), glycine, a polyethylene glycol (PEG), and a sugar.