Method for assaying whole blood

• US 7,338,809 B2
• Filed: 09/09/2003
• Issued: 03/04/2008
• Est. Priority Date: 03/09/2001
• Status: Expired due to Term

• Current Assignee: Mitsubishi Chemical Medience Corporation (Mitsubishi Chemical Group Corp.)
• Original Assignee: Mitsubishi Kagaku Iatron, Inc. (Mitsubishi Chemical Group Corp.)
• Inventors: Yokoi, Hiroyuki
• Primary Examiner(s): GABEL, GAILENE
• Application Number:
  US10/657,118
• Publication Number:
  US 20040048397A1
• Time in Patent Office: 1,638 Days
• Field of Search: 435/2, 435/7.1, 435/7.24, 435/7.25, 435/7.92, 435/7.94, 435/173.9, 435/297.2, 435/339, 436/517, 436/518, 436/524, 436/526, 436/528, 436/538, 436/10, 436/17, 436/18, 436/172, 436/808, 436/522, 436/166, 436/176, 422/61
• US Class Current: 436/176
• 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: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

In a method for measuring an analyte, which comprises a reaction step of forming a reaction system including a sample containing whole blood, a first substance carried by a solid carrier and specifically binding to an analyte contained in the sample and a second substance specifically binding to the analyte and allowing the analyte to react with the first and second substances and a measurement step of measuring the formed reaction product, (1) the reaction step is performed in a state that blood cells are not disrupted, and (2) at least the reaction step is performed in the presence of a sufficient amount of a detergent that does not cause hemolysis, does not inhibit reactions of the analyte with the first and second substances specifically binding to the analyte and can prevent influence on the reaction system of a component existing in the reaction system.

Claims

1. A method for measuring quantitatively or qualitatively an analyte in a whole blood sample, comprising:

forming a reaction system by mixing the whole blood sample with a whole blood treatment solution comprising detergent of the type that does not cause hemolysis, and adding to the mixture of the whole blood sample and the whole blood treatment solution a first substance which is immobilized on a solid carrier and specifically binds to an analyte contained in the whole blood sample and a second substance which specifically binds to the analyte to allow the analyte to react with the first and second substances to form a complex of first substance-analyte-second substance,

separating the complex, and

detecting the complex to measure quantitatively or qualitatively the analyte in the complex,

wherein said reaction system comprises the detergent in a concentration range of 0.5 to 5% so that hemolysis is prevented.

2. The method according to claim 1, wherein the detergent is selected from the group consisting of polyoxyethylene sorbitan ester type detergents and sulfobetaine type detergents.

3. The method according to claim 1, wherein the ratio of the whole blood sample and the whole blood treatment solution is in the range of 99:

1 to 5;

95.

4. The method according to claim 1, wherein the reaction system is formed by mixing the whole blood sample with a whole blood treatment solution comprising detergent, then adding the first substance to the mixture of the whole blood sample and the whole blood treatment solution, and then adding the second substance to the mixture of the whole blood sample, the whole blood treatment solution, and the first substance.

5. The method according to claim 1, wherein the second substance is labeled with a labeling substance.

6. The method according to claim 1, wherein the first and second substances which specifically bind to the analyte are an antigen or an antibody.

7. A reagent kit for measuring an analyte in a whole blood sample, which comprises a first substance which is immobilized on a solid carrier and specifically binds to the analyte, a second substance which specifically binds to the analyte, and a whole blood treatment solution which comprises detergent of the type that does not cause hemolysis,

wherein said reaction system comprises the detergent in a concentration range of 0.5 to 5% so that hemolysis is prevented.