Non-specific reaction inhibitor

Abstract

Disclosed is a non-specific reaction inhibitor for use in an immunological measurement, comprising a complex of an antibody or a fragment of the antibody capable of specifically binding to a non-specific reaction factor, and a polymer. The non-specific reaction inhibitor can inhibit a non-specific reaction which may interfere with the accurate detection or quantification of a trace substance in an immunological measurement method.

Description

TECHNICAL FIELD[0001]The present invention relates to a non-specific reaction inhibitor capable of inhibiting a non-specific reaction which may interfere with the accurate detection or quantification of a trace substance in an immunological measurement method.BACKGROUND ART[0002]Even in a highly specific immunological measurement method utilizing an antigen-antibody reaction, there has been a problem that some samples which do not contain an antigen to be measured show positive measured values, i.e., measured values different from the true values. This phenomenon is called a non-specific reaction.[0003]As an immunological measurement method utilizing an insoluble carrier on which an antibody specifically binding with an antigen to be measured is immobilized, a latex agglutination optical measurement method and an enzyme immunoassay are known. When such a method is used to measure the concentration of an antigen contained in samples, there are some cases where certain samples contain...

AI Technical Summary

Benefits of technology

[0019]Diagnosis and treatment can be generally classified into an in vivo case and an in vitro case. Almost all uses of a polymer-modified antibody are utilized in the treatment or diagnosis in vivo. For example, when an antibody linked to a drug or an isotope is administered into a body as a therapeutic agent or a detecting agent for a lesion such as a tumor, the antibody is modified with a polymer. By contrast, in the diagnosis in vitro, no use of a polymer-modified antibody has been found, and no polymer-modified antibody has been utilized. An agent is not administered into a body in vitro, in contrast with in vivo cases. Therefore, when the use in vitro was examined, remarkably advantageous effects other than improvement of stability were necessary. As described above, the present invention provides a new application in the diagnosis in vitro by newly finding usefulness as a “non-specific reaction inhibitor”.

[0020]The present invention is to provide a new use as a “non-specific reaction inhibitor”, and the present invention shows advantageous effects in comparison with conventional techniques of inhibiting a non-specific reaction.

[0021]The present inventors conducted intensive studies on non-specific reaction inhibitors and, as a result, found that problems involving the immunological nephelometric reaction and the maintenance of storage could be solved by chemically linking a polymer to an antibody specific to a non-specific reaction factor or a fragment of the antibody, and that the polymer-modified product exhibited the effect of inhibiting a non-specific reaction when small quantities were used.

[0022]The present invention relates to a non-specific reaction inhibitor for use in an immunological measurement, comprising a complex of an antibody or a fragment of the antibody capable of specifically binding to a non-specific reaction factor, and a polymer.

[0023]According to a preferred embodiment of the non-specific reaction inhibitor of the present invention, the polymer is a compound selected from the group consisting of a polysaccharide, a protein, and an organic high molecular weight polymer, and is more preferably polyethylene glycol.

[0024]According to another preferred embodiment of the non-specific reaction inhibitor of the present invention, the molecular weight of the polymer is 200 Da to 1000 kDa.

Problems solved by technology

Even in a highly specific immunological measurement method utilizing an antigen-antibody reaction, there has been a problem that some samples which do not contain an antigen to be measured show positive measured values, i.e., measured values different from the true values.

In these cases, such samples raise a problem that samples which do not contain an antigen to be measured show positive measured values, i.e., measured values different from the true values.

Under these conditions, when a latex agglutination optical measurement method in which the amount of an antigen is determined by optically measuring turbidity is carried out, sometimes an accurate measured value cannot be obtained due to the immunological nephelometric reaction.

As described above, a non-specific reaction due to a non-specific reaction factor can be avoided, but there remains a problem that the avoidance newly results in a secondary immunological nephelometric reaction.

In addition, there is another problem that when a sample contains rheumatoid factors, the immunological nephelometric reaction is increased because the rheumatoid factors bind with the Fc region of an IgG or IgM molecule.

However, when the amount added is less than the amount sufficient to inhibit the effect of a non-specific reaction factor, the effect of inhibiting the non-specific reaction is insufficient.

The present inventors further evaluated a measurement reagent containing the F(ab′)2 as the inhibitor, it was found that the measurement reagent has a disadvantage in maintaining the effect of inhibiting a non-specific reaction.

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