Immunological method for the determination of a haemoglobin derivative

• US 5,541,117 A
• Filed: 03/04/1993
• Issued: 07/30/1996
• Est. Priority Date: 03/05/1992
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Schneider, Erich, Karl, Johann, Kerscher, Lorenz
• Primary Examiner(s): Scheiner, Toni R.
• Assistant Examiner(s): Green, Lora M.
• Application Number:
  US08/026,464
• Time in Patent Office: 1,244 Days
• Field of Search: 436/518, 436/523, 436/531, 436/532, 436/533, 436/534, 436/66, 436/67, 436/808, 436/815, 435/7.1, 435/962
• US Class Current: 436/518
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

The invention concerns a method for the determination of the content of a particular haemoglobin derivative in a blood sample. In particular, the invention concerns a method for the determination of the content of haemoglobin derivatives such as glycated haemoglobin which require the separate determination of the total haemoglobin content and the determination of the haemoglobin derivative in order to determine the proportion of the derivatized haemoglobin in the blood as well as a suitable haemolysis reagent for this.

Claims

1. Method for immunologically determining glycated hemoglobin in blood, comprising:

(a) treating a blood sample which contains said glycated hemoglobin with a hemolysis reagent consisting essentially of an ionic detergent which has a pH of from 5.5 to 9.5, for a period of no more than 10 minutes, at a temperature of from 4°

C. to 37°

C., to hemolyze said blood sample,

(b) contacting the hemolyzed blood sample with at least one immune reagent which specifically binds to glycated hemoglobin, and

(c) determining binding of said immune reagent as a determination of glycated hemoglobin in said blood sample.

5. The method of claim 1, 2, 3 or 4, further comprising contacting said hemolyzed blood sample with a buffer which contains a non-ionic or zwitterionic detergent prior to determining binding of said first immune reactant to said hemoglobin derivative.

6. The method of claim 5, wherein said buffer contains said first immune reactant.

7. The method of claim 1, 2, 3 or 4, wherein said glycated hemoglobin is HbA_1c.

8. The method of claim 1, 2, 3 or 4, further comprising determining total hemoglobin content in said hemolyzed blood sample chromophorically.

11. The method of claim 1, 2, 3 or 4, wherein said ionic detergent is sodium dodecylsulfate, sodium dioctylsulfocuccinate, tetradecyltrimethyl ammonium bromide, or cetyltrimethyl ammonium bromide.

12. The method of claim 1, 2, 3 or 4, wherein said hemolysis reagent contains a buffer.

13. The method of claim 1, 2, 3 or 4, wherein said hemolysis reagent contains an oxidizing agent.

2. Method for immunologically determining glycated hemoglobin in blood, comprising:

(a) treating a blood sample which contains glycated hemoglobin with a hemolysis reagent consisting essentially of an ionic detergent which has a pH of from 5 to 9.5, for a period of no more than 10 minutes, at a temperature of from 4°

C. to 37°

C., to hemolyze said blood sample,

(b) contacting said hemolyzed blood sample with (i) a first immune reactant which specifically binds to glycated hemoglobin and (ii) a second immune reactant which binds to said first immune reactant, and

(c) determining binding of said first immune reactant to said second immune reactant as a determination of glycated hemoglobin in said blood sample.

3. Method for immunologically determining glycated hemoglobin in blood, comprising:

(a) treating a blood sample which contains glycated hemoglobin with a hemolysis reagent consisting essentially of a mixture of an ionic detergent and a non-ionic detergent, said mixture having a pH of from 5.0 to 9.5, for a period of no more than 10 minutes, a temperature of from 4°

C. to 37°

C. to hemolyze said blood sample,

(b) contacting said hemolyzed blood sample with at least one immune reactant which specifically binds to glycated hemoglobin, and

(c) determining binding of said immune reactant as a determination of glycated hemoglobin in said blood sample.

9. The method of claim 3 or 4, comprises treating said sample for two minutes or less.

10. The method of claim 3 or 4, comprising incubating said sample at room temperature.

4. Method for immunologically determining glycated hemoglobin in a blood sample, comprising:

(a) treating a blood sample which contains glycated hemoglobin with a hemolysis reagent consisting essentially of a mixture of an ionic detergent and a non-ionic detergent, wherein said mixture has a pH of from 5.0 to 9.5, for a period of no more than 10 minutes, at a temperature of from 4°

C. to 37°

C. to hemolyze said blood sample,

(b) contacting said hemolyzed blood sample with (i) a first immune reactant which specifically binds to glycated hemoglobin and (ii) a second immune reactant which binds to said first immune reactant, and

(c) determining said binding as a determination of glycated hemoglobin in said blood sample.