Combined assay for current glucose level and intermediate or long-term glycemic control

• US 6,958,129 B2
• Filed: 09/19/2003
• Issued: 10/25/2005
• Est. Priority Date: 04/07/1995
• Status: Expired due to Fees

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Neyer, Gebhard, Galen, Robert S., Hoblitzell, Talei, Burd, John F.
• Primary Examiner(s): Gakh, Yelena G.
• Application Number:
  US10/666,364
• Publication Number:
  US 20040265941A1
• Time in Patent Office: 767 Days
• Field of Search: 422/56, 422/57, 422/61, 435/14, 435/970, 435/287.7, 435/287.9, 436/828
• US Class Current: 422/400
• CPC Class Codes: C12Q 1/34 involving hydrolase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 2326/12 3,3',5,5'-Tetramethylbenzidine, i.e. TMB
• CPC Class Codes: C12Q 2326/14 Ortho-Tolidine, i.e. 3,3'-dimethyl-(1,1'-biphenyl-4,4'-diamine)
• CPC Class Codes: C12Q 2326/92 Nitro blue tetrazolium chloride, i.e. NBT
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: G01N 2333/42 Lectins, e.g. concanavalin, phytohaemagglutinin
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/828 Protein A
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject'"'"'s body fluid, such as whole blood. The glucose concentration is indicative of the subject'"'"'s immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Claims

1. An integrated glycemic test system for determination of a long term glycernic condition, the system comprising:

a signal producing system indicative of glucose concentration in a whole blood sample;

a signal producing system indicative of total protein concentration in the whole blood sample;

a signal producing system indicative of non-glycated protein concentration in the whole blood sample; and

a glucose concentration determining means that is responsive to the signal producing system indicative of glucose concentration; and

a glycated protein concentration determining means that is responsive to the signal producing system indicative of total protein and the signal producing system indicative of non-glycated protein, with a difference between the total protein and the non-glycated protein being indicative of glycated protein concentration in the whole blood sample;

wherein the glucose concentration and the glycated protein concentration indicate long-term integrated glycemic condition.