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Kit for detecting relevant autoantibody spectrum of autoimmune liver disease

An autoimmune and autoantibody technology, applied in the field of disease diagnosis kits and kits for detecting autoimmune liver disease-related autoantibody profiles, can solve the problem of easy misjudgment and missed judgment, low specificity, and no auxiliary diagnosis, etc. problem, to achieve the effect of color stability

Inactive Publication Date: 2015-03-25
GUANGZHOU NATI BIOTECH 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
[0008] 1. WB is used for a long time and the operation is complicated
[0009] 2. WB uses natural mixed antigens. During the experiment, the problem of not finding the target band and band offset often occurs, which causes a lot of difficulties in the interpretation of the results, and it is easy to misjudge and miss the judgment.
[0010] 3. The ELISA method can only detect one item at a time, and the efficiency is not high
[0011] 4. The IFA method can only be used for screening and does not have the significance of auxiliary diagnosis
[0012] 5. At present, there is no linear immunoassay that can simultaneously detect 7 kinds of autoantibodies related to autoimmune liver disease and distinguish liver injury caused by Sjogren's syndrome
[0013] 6. In the current kits, there is generally no quality control line or a quality control line can only be used as a comparison of one test result, and there is no quality control line that can be used as a comparison of at least two test results at the same time

Method used

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  • Kit for detecting relevant autoantibody spectrum of autoimmune liver disease

Examples

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Comparison scheme
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Embodiment 1

[0041] The autoimmune liver disease antibody profile detection kit in this embodiment includes membrane strips, enzyme labeling solution, substrate and concentrated washing incubation solution, wherein the selection of enzyme labeling solution and concentrated washing incubation solution belongs to the prior art.

[0042] Such as figure 1 As shown, the membrane strip is composed of a fixed plate and antigen strips, critical quality control strips, and functional quality control lines fixed on the nitrocellulose membrane in sequence. The antigen strips are composed of AMA-M2, LKM-1, LC-1, and SLA , F-actin, gp210, Sp100 and La / SS-B 8 or 6 independent streaks were drawn on the nitrocellulose membrane to form, and the critical quality control band was at least 6 antigens in the antigen band at the same time Control band for the band. The method for determining the critical quality control value of the critical quality control zone is as follows:

[0043] 1) Select 30 confirmed ...

Embodiment 2

[0048] This example is for the antigen strips drawn on the nitrocellulose membrane by AMA-M2, LKM-1, LC-1, SLA, F-actin, gp210, Sp100 and La / SS-B, which are 8 independent of each other belt for testing. On the basis of Example 1, in order to make the result judgment more simple and reliable, the width of each antigen band is uniformly set, the band interval is equal, the width of the antigen band is 0.5-2mm, and the interval between adjacent antigen bands is 2mm ~ 10mm. Using the improved TMB-containing 0.042% substrate, it can be terminated with purified water, deionized water or distilled water, and the color is stable after termination, and will not fade within 2 years. All blotted antigens are highly purified, and the latest coating technology is used, the specific method is described later.

[0049] Determination of critical quality control values:

[0050] 1) Determine the critical quality control value of each antibody

[0051] Randomly select 30 cases of fresh seru...

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Abstract

The invention discloses a kit for detecting the relevant autoantibody spectrum of an autoimmune liver disease, and belongs to the technical field of biology. The kit comprises a membrane strip, an enzyme label liquid, a substrate and an enzyme label incubation buffer liquid, wherein the membrane strip is composed of a fixed plate as well as an antigen strip, a critical quality control strip and a functional quality control line which are sequentially fixed on a nitrocellulose membrane, wherein the antigen strip is formed by drawing 8 or 6 mutually independent drawing lines in AMA-M2, LKM-1, LC-1, SLA, F-action, gp210, Sp100 and La / SS-B on the nitrocellulose membrane. The kit can be used for detecting 8 relevant antibodies of the autoimmune liver disease, and can act as a basis for auxiliary diagnosis. The additionally arranged La / SS-B strip can be used for differentiating the autoimmune liver disease and liver injury caused by sicca syndrome, and thus providing a basis for the correct dosage regimen.

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 autoantibody spectrum related to autoimmune liver disease. Background technique [0002] Autoimmune liver disease is a kind of chronic progressive liver disease with unknown etiology, which is urgently related to autoimmune reaction, with hidden early clinical manifestations, and it is difficult to distinguish it from chronic viral hepatitis. The treatment methods of these two diseases are very different. If the treatment Improper treatment can eventually lead to liver fibrosis and cirrhosis, and the life of the patient can only be prolonged by liver transplantation. Therefore, early diagnosis and differential diagnosis of autoimmune liver disease is very urgent and necessary. Autoimmune liver diseases have specific antibodies, which are an important basis for early diagnosis and differential diagnosis of diseases. ...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/576G01N33/558
CPCG01N33/68G01N33/558G01N33/576
Inventor 张伟民黄颖冰
Owner GUANGZHOU NATI BIOTECH CO LTD
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