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Kit for detecting antinuclear antibody spectrum related to autoimmune diseases (AIDs)

An autoimmune disease and antinuclear antibody spectrum technology, applied in the field of disease diagnosis kits and autoimmune disease-related antinuclear antibody spectrum detection kits, can solve the problem that cannot be used as a basis for diagnosis, false positives, and different strip intervals and other problems, to achieve the effect of simple and reliable result judgment, uniform width and clean background

Active Publication Date: 2014-08-20
SICHUAN XINCHENG BIOLOGICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has the following disadvantages: it cannot be used as a basis for diagnosis; the judgment of the result requires rich experience; the significance of titer is greater than that of karyotype, but the judgment of titer is highly subjective; the sensitivity is low and the specificity is not high
[0009] 2. Most of the purified antigens used are extracted from natural tissues, and the lack of purity (≥90%) still affects the sensitivity and specificity of detection
[0010] 3. The background of the membrane strip is dark, sometimes darker than the positive strip, which affects the reliability of the result
[0011] 4. Different antigen bands have different widths and band intervals, which affect the accurate interpretation of the results
[0012] 5. Similar products, such as the kit disclosed in CN200810132304.8, do not have a critical quality control band, and the interpretation of the results requires an additional control film strip, which increases the cost of the experiment. May cause false positive or false negative
At present, some related products also have critical quality control bands, but one quality control band can only interpret the results of one detection band or item. At present, there is no critical quality control band for two or more bands at the same time. Application of Interpretation

Method used

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  • Kit for detecting antinuclear antibody spectrum related to autoimmune diseases (AIDs)
  • Kit for detecting antinuclear antibody spectrum related to autoimmune diseases (AIDs)
  • Kit for detecting antinuclear antibody spectrum related to autoimmune diseases (AIDs)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] see Figure 1 to Figure 3 as shown, figure 2 The CO quality control line is the critical quality control zone; the kit for detecting autoimmune disease-related antinuclear antibody spectrum in this embodiment includes membrane strips, enzyme labeling solution, substrate and concentrated washing incubation solution, wherein enzyme labeling solution, The selection and scope of the substrate and the concentrated washing incubation solution belong to the prior art. For the enzyme label solution, the substrate and the concentrated washing incubation solution, the technical solution of the present invention can also be realized by selecting products of the prior art.

[0036] The membrane strip is composed of slides and antigen strips, critical quality control strips, and functional quality control lines fixed on the slides in sequence. The antigen strips are composed of dsDNA, nucleosomes, SmD1, ribosomal P0 protein, histone, U1 snRNP, Ro / SS-A(52KD), Ro / SS-A(60KD), La / SS-B...

Embodiment 2

[0044] This embodiment is made of dsDNA, nucleosome, SmD1, ribosomal P0 protein, histone, U1 snRNP, Ro / SS-A (52KD), Ro / SS-A (60 KD), La / SS-B, Scl-70, CENP-B, Jo-1, AMA-M2, PM-Scl, PCNA, Mi-2 and Ku, which are 17 independent antigen bands streaked on nitrocellulose membrane or nylon membrane test determination. On the basis of Example 1, in order to make the result judgment more simple and reliable, the width of each antigen strip is uniformly set, and the interval between the strips is equal. The width of the antigen strip is 0.5mm-3mm, and the interval between adjacent antigen strips 2mm-20mm, the background of the membrane strip is clean, and an improved single-reagent substrate is used, which does not need to be terminated after adding the substrate. Reagents; all imprinted antigens are highly purified, and the latest international coating technology is used. The specific coating method is described later.

[0045] Determination of critical quality control values:

[004...

Embodiment 3

[0056] This embodiment is the critical quality control value of the membrane strip determined according to embodiment 2 (in image 3 and in all examples of the present invention, CO p is the critical quality control value of a single antibody, CO is the critical quality control value of the entire membrane strip), to adjust the concentration of human IgG coated in the critical quality control zone, and finally determine the coating concentration and coating process of the critical quality control zone. The specific operation is: dissolve a certain concentration of human IgG in Tris or Hepes buffer, then use a fully automatic spotting instrument to streak on the nitrocellulose membrane, and prepare finished membrane strips through sealing, drying, cutting and other processes. And only the critical quality control band is coated on the film strip. Randomly select 30 film strips for detection with this kit, and scan the gray scale, and calculate the mean value (M S ), standard ...

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Abstract

The invention relates to a kit for detecting antinuclear antibody spectrum related to AIDs. The kit comprises a membrane strip, enzyme-labeled liquid, a substrate and concentrating and washing incubation liquid, wherein the membrane strip is composed of a carrier piece and an antigen band, a critical quality control band and a functional quality control line which are sequentially fixed on the carrier piece. The antigen band is composed of at least two of dsDNA, nucleosomes, SmD1, ribosome P0proteins, histones, U1snRNP, Ro / SS-A(52KD), Ro / SS-A(60KD), La / SS-B, Sc1-70, CENP-B, Jo-1, AMA-M2, PM-Sc1, PCNA, Mi-2 and Ku through independent marking to a nitrocellulose membrane or a nylon membrane. The kit is provided with the ingenious critical quality control band, one critical quality control band can play a role in interpreting two or even more detection bands (antigen bands), and result determination is simpler and more reliable.

Description

technical field [0001] The invention belongs to the field of biotechnology, and relates to a kit for diagnosing diseases, in particular to a kit for detecting antinuclear antibody spectrum related to autoimmune diseases. Background technique [0002] Autoimmunity is the reaction of the body's immune system to self-antigens, producing autoantibodies and self-responsive T cells. Under normal physiological conditions, autoimmunity can promptly remove aging and dead self-cells and maintain the stability of the internal environment. In some pathological states, self-responsive T cells and autoantibodies that directly and indirectly destroy self-tissues may be produced, and cause lesions and dysfunction of corresponding organ tissues, which are called autoimmune diseases (AID) ). Common autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, multiple dermatitis / myositis, mixed connective tissue disease, hyperthyroidism, juvenile diabet...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/558
Inventor 李想周帅何涛涛陈洪郑丽陈卫陈川
Owner SICHUAN XINCHENG BIOLOGICAL CO LTD
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