Method for immunologically assaying hemoglobin A1c in specimen

Abstract

Means that enables an immunoassay of hemoglobin A1c in a whole blood sample without pretreatment of the sample is disclosed. The immunoassay of hemoglobin A1c in a sample according to the present invention comprises bringing latex particles into contact with a non-pretreated whole blood sample in a hypotonic solution, and then bringing hemoglobin A1c adsorbed on the latex particles into contact with an anti-hemoglobin A1c antibody. The immunoassay is preferably carried out by an agglutination method. The hypotonic solution is, for example, a buffer containing a Good's buffer at a concentration of 0.02 to 0.2 mol / L, which Good's buffer has the maximum buffer capacity in the neutral to alkaline region.

Description

technical field [0001] The present invention relates to an immunoassay method for hemoglobin A1c in a sample. Background technique [0002] Hemoglobin A1c (HbA1c) is a hemoglobin (Hb) with a heterotetramer structure consisting of 2 α chains and 2 β chains, in which the α amino group of the N-terminal valine of the β chain is a non-enzymatic sugar sylated glycated hemoglobin. The blood level of this HbA1c reflects the long-term blood sugar control state of diabetes. Therefore, the measurement of HbA1c is clinically significant in order to know the state of blood sugar control, and the measurement of HbA1c is performed for monitoring the therapeutic effect of diabetes and the like. Afterwards, the diagnostic criteria for diabetes were revised from July 2010, and it was found that the HbA1c value has a certain relationship with the onset of retinopathy, so HbA1c above 6.1% (JDS value) was added to the criteria for diabetes (non-diabetic). Patent Document 1). Furthermore, si...

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Problems solved by technology

[0004] However, in fact, there are also equipment that cannot perform pretreatment such as centrifugation, hemolysis, and dilution. Compared with the HPLC method, which can be said to be automated, the fact that pretreatment is required for the immunological method remains the same.

For example, even if the whole blood sample is diluted and hemolyzed without diluting hemolysis of the centrifuged blood, in the measurement of HbA1c, the hemoglobin in the erythrocytes is the measurement object and exists in the erythrocytes. If it is erected, the red blood cells will settle, so that it will not be possible to collect the settled red blood cells when sampling from the liquid surface like a serum sample

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