Immunoassay Reagent Composition

• US 20120315647A1
• Filed: 08/15/2012
• Published: 12/13/2012
• Est. Priority Date: 09/10/2003
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Miller, Cary James, Maczuszenko, Andy
• Granted Patent: US 8,765,075 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• 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

1-16. -16. (canceled)

17. A dry reagent composition configured as a solute to be dissolved into whole-blood prior to a whole-blood immunoassay, the dry reagent composition comprising:

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

18. The dry reagent composition of claim 17, wherein the support matrix is cellulose, polyvinyl alcohol, gelatin, or mixtures thereof.

19. The dry reagent composition of claim 17, wherein the dry reagent composition further comprises sodium azide and Tween 20.

25. The dry reagent composition of claim 17, wherein the dry reagent composition further comprises heparin.

26. The dry reagent composition of claim 17, wherein the buffer is Tris.

20. A dry reagent composition configured as a solute to be dissolved into whole-blood prior to a whole-blood immunoassay, the dry reagent composition comprising dextran and a salt in a support matrix.

21. The dry reagent composition of claim 20, wherein the salt is NaCl, KCl, MgCl₂, CaCl₂, LiCl, NaNO₃, Na₂SO₄, or mixtures thereof.

22. The dry reagent composition of claim 20, wherein the salt is a buffer salt comprising Tris, 2-(N-morpholino)ethanesulfonic acid (MES), phosphate, or 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES).

23. The dry reagent composition of claim 20, wherein the dry reagent composition further comprises lactitol.

24. The dry reagent composition of claim 20, wherein the support matrix is cellulose, polyvinyl alcohol, gelatin, or mixtures thereof.

25-1. The dry reagent composition of claim 17, wherein the buffer is Tris, 2-(N-morpholino)ethanesulfonic acid (MES), phosphate, or 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES).