Novel improved immunochromatographic test strip, and preparation and application thereof

An immunochromatographic test paper, a new technology, applied in the biological field, can solve the problems of uneven detection line color, viscosity and volume difference, high false positive, etc., and achieve the effect of uniform detection line color, easy production, and low false positive

Active Publication Date: 2016-04-13
广州伊康纳斯生物医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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

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  • Novel improved immunochromatographic test strip, and preparation and application thereof
  • Novel improved immunochromatographic test strip, and preparation and application thereof
  • Novel improved immunochromatographic test strip, and preparation and application thereof

Examples

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Example Embodiment

[0033] Example 1

[0034] The hepatitis B surface antigen colloidal gold test paper improves the sensitivity, removes false positives, accelerates the whitening of the reaction film background, and improves the uniform color of the bar.

[0035] 1-1 Preparation process:

[0036] 1) Reaction membrane 4: Coat 0.5mg / ml hepatitis B surface antigen monoclonal antibody A and 1.2mg / ml goat anti-mouse polyclonal antibody in parallel on the detection line and control line of the nitrocellulose membrane, and dry it. Get reaction film 4;

[0037] 2) Colloidal particles (gold label) conjugate release pad 2: Colloidal gold particles with a particle size of 40 nm are prepared by the trisodium citrate reduction method, and the colloidal gold solution mass is 1% (mass percentage) 0.1M / L potassium carbonate solution Adjust the pH, then add 10ug / ml hepatitis B surface antigen monoclonal antibody B, mix quickly and add 1% (mass percentage) stabilizer of colloidal gold volume solution mass, high-speed r...

Example Embodiment

[0057] Example 2

[0058] Hepatitis C antibody colloidal gold test paper improves the sensitivity, reduces the incidence of false positives, improves the HOOK effect, accelerates the whitening of the reaction film background, and improves the uniform color of the bars.

[0059] 2-1 Preparation process:

[0060] 1) Reactive membrane (4): Coat 0.6mg / ml hepatitis C gene recombinant antigen A and 1.0mg / ml goat anti-mouse polyclonal antibody in parallel on the detection line and control line of the nitrocellulose membrane. Dry reaction membrane 4;

[0061] 2) Colloidal particles (gold label) conjugate release pad 2: Colloidal gold particles with a particle size of 40 nm are prepared by the trisodium citrate reduction method, and 0.1M / L carbonic acid equivalent to 0.7% (mass percentage) of the colloidal gold solution is used Adjust the pH value by potassium, then add 10ug / ml hepatitis C gene recombinant antigen B, mix quickly and add a stabilizer equivalent to 1% (mass percentage) of the c...

Example Embodiment

[0083] Example 3

[0084] The amphetamine colloidal gold test paper improves the sensitivity, accelerates the whitening of the reaction film background, and improves the uniform color of the bar.

[0085] 3-1 Preparation process:

[0086] 1) Reactive membrane 4: Coat 0.2mg / ml amphetamine-BSA conjugate and 0.8mg / ml goat anti-mouse polyclonal antibody in parallel on the detection line and the control line of the nitrocellulose membrane. Dry reaction membrane 4;

[0087] 2) Colloidal particles (gold label) conjugate release pad 2: Colloidal gold particles with a particle size of 40 nm are prepared by the trisodium citrate reduction method, using 0.1M / L carbonic acid equivalent to 0.9% (mass percentage) of the colloidal gold solution mass Adjust the pH value by potassium, then add 10ug / ml amphetamine monoclonal antibody, mix quickly and add stabilizer equivalent to 1% (mass percentage) of colloidal gold solution mass, high-speed refrigerated centrifuge 5000 rpm, 10,000 rpm Collect the g...

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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 ...

Claims

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Application Information

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IPC IPC(8): G01N33/558G01N33/571G01N33/576G01N33/94
CPCG01N33/558G01N33/571G01N33/5761G01N33/5767G01N33/946
Inventor 余期川郑会义
Owner 广州伊康纳斯生物医药科技股份有限公司
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