Novel improved immunochromatographic test strip, and preparation and application thereof

Abstract

The invention provides a novel improved immunochromatographic test strip, and preparation and application thereof. According to the invention, a buffer pad is additionally arranged between a reaction membrane and a colloidal particle conjugate releasing pad with a marked antibody against a to-be-detected object, so colloidal particles of the antibody against the to-be-detected object disintegrated from the releasing pad can be more uniformly dissolved in a detection sample in the buffer pad before falling onto the reaction membrane, adequate reaction time is obtained, and a corresponding target detection object undergoes more complete immunoreaction; thus, the reaction efficiency of the antibody against the to-be-detected object and the target detection object in the sample is maximized. Compared with conventional immunity immunochromatographic test strips, the novel improved immunochromatographic test strip in the invention has the advantages of high sensitivity, low false positive diagnosis rate, uniform color of a test line; and a preparation method for the novel improved immunochromatographic test strip low in cost, simple to operate and applicable to preparation of immunochromatographic test strips of a variety of forms.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to the construction of a novel and improved immunochromatographic test strip, its preparation method and application. Background technique [0002] Immunochromatography is a rapid diagnostic technique that emerged in the 1990s. Its principle is to use antigen-antibody reaction to pre-immobilize two capture agents, specific antigen (or antibody) and second antibody, on the reaction membrane. A detection line (Test1ine) and a control line (Control1ine); and colloidal particles immobilized on the release pad of the colloidal particle conjugate and labeled with an antibody against the object to be tested. The test strip is inserted into the sample solution. The sample solution first dissolves the colloidal particles fixed on the colloidal particle conjugate release pad, and reacts specifically with it and forms a complex. When the solution reaches the antigen (or antibody) area ...

AI Technical Summary

Problems solved by technology

[0009] However, there is an obvious defect in the setting of the traditional old immunochromatographic test strips, that is, the colloidal particles labeled with the anti-analyte antibody disintegrate from the conjugate release pad and directly reach the display area during use. Quickly passed the test line 3 (Test1ine)

During this process, the colloidal particles labeled with anti-analyte antibodies often cannot be quickly and uniformly reconstituted in the test sample, and fully immunoreact with the corresponding target test substance

In fact, in the detection of many traditional and old immunochromatographic test strips, it was found that due to the limitations of the traditional old immunochromatographic test strips and the imperfection of the colloidal particle production process of the anti-analyte antibody As well as the difference in viscosity and volume of the test samples, the colloidal particles of the anti-analyte antibody in many traditional immunochromatographic test strips are disintegrated and redissolved insufficiently, resulting in the display area (reaction film) There are many clusters of uneven colloidal particle chromatography on the membrane surface, even though some immunochromatographic test strips seem to be better resolved on the surface of the colloidal particles labeled with anti-analyte antibodies from the colloidal particle conjugate release pad After the disintegration and the dissolution of the test sample, the colloidal particles marked with the anti-analyte antibody on the display area (reaction film) are relatively uniform by naked eyes, but in fact, the anti-analyte antibody labeled with the anti-analyte antibody after disintegration When the mixed solution of antibody colloidal particles and detection samples is observed under a microscope, it can be seen that the colloidal particles labeled with anti-analyte antibodies are not fully and uniformly dissolved in the detection sample, so they cannot be fully mixed with the corresponding target detection substances. local immune response

As a result, the efficiency of the colloidal particle conjugate release pad labeled with anti-analyte antibody cannot be fully exerted

This has led to quality problems such as low sensitivity, high false positives, and uneven detection line color of the traditional old immunochromatographic test strips. Therefore, it is necessary to improve the settings of the traditional old immunochromatographic test strips to make up for the above. Insufficient, in order to further improve the sensitivity of immunochromatographic test strips and detect quality problems such as uneven color of the line

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