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Homogeneous immunoassay kit, detection method and application thereof

A technology of immunoassay and kit, which is applied in joint detection of the same virus antigen, homogeneous immunoassay kit, and antibody application field, which can solve the problem of inability to provide reliable information for clinical treatment, inability to distinguish positive signal values, and increase the difficulty of reagent development To achieve the effect of improving anti-hook effect ability, improving sensitivity and reducing difficulty

Active Publication Date: 2018-05-18
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage is that it is impossible to distinguish whether the positive signal value is caused by antigen or antibody, so that the course of the disease cannot be accurately judged, and reliable information cannot be provided for clinical treatment.
In addition, the labeled raw materials in the detection reagent need to be strictly screened, and the labeled antigen and antibody cannot have cross-reaction, which increases the difficulty of reagent development and prolongs the development cycle
At the same time, due to the artificial avoidance of some sites, it is bound to sacrifice a part of the sensitivity of antigen and / or antibody detection

Method used

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  • Homogeneous immunoassay kit, detection method and application thereof
  • Homogeneous immunoassay kit, detection method and application thereof
  • Homogeneous immunoassay kit, detection method and application thereof

Examples

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Effect test

Embodiment 1

[0135] Embodiment 1: the sensitivity test of the homogeneous immunological method of single hole joint detection human hepatitis C core antigen (HCV Core Ag)

[0136] 1. Preparation of markers

[0137] The HCV antibody detection kit produced by Shanghai Boyang was used, the batch number is: 1606L. The specific labeling process of each reagent component is omitted.

[0138] 2. Preparation of reagent Ⅰ (sample diluent)

[0139]Use the sample diluent in the above-mentioned finished kit to carry out serial dilution of 1 antibody-positive serum to 10 times, 100 times, 1000 times, 10,000 times, 100,000 times and 1 million times respectively. The above-mentioned dilution solution was used as a sample for detection with the kit, and a dilution with a signal value of about 20,000 was found. Use this dilution as the ratio of adding the antibody to the sample diluent, and prepare 20ml of the sample diluent according to this ratio.

[0140] 3. Detection of recombinant HCV core antigen...

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Abstract

The invention relates to a homogeneous immunoassay kit, detection method and application thereof in the technical field of biology. The kit comprises a reagent I, a reagent II, a reagent III and a reagent IV, wherein the reagent I contains a first counterpart, and the first counterpart is a known antigen or a known antibody specially combined with an antigen to be detected in a sample to be detected; the reagent II contains a receptor which can react with singlet oxygen to generate a detectable signal and a second counterpart combined with the receptor; the reagent III contains a third counterpart specially combined with the first counterpart; the reagent IV contains a donor which can generate the singlet oxygen in an excitation state; the surface of the third counterpart is coated with biotin, and the surface of the donor is coated with streptavidin. By utilizing combined detection of the kit and the homogeneous immunoassay method of the antigen and the antibody, the screening difficulty of raw materials is reduced, and the detection sensitivity is promoted at the same time.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a homogeneous immune kit, a detection method and its application in joint detection of the same virus antigen and antibody. Background technique [0002] In some in vitro diagnostic items using chemiluminescence detection, it is necessary to detect antigens and antibodies in samples at the same time. For example, the detection of human immunodeficiency virus (Human Immunodeficiency Virus, HIV) has been developed from the previous three-generation reagents that only detect virus antibodies to the current four-generation AIDS detection reagents that are more commonly used for combined detection of antigens and antibodies. In this way, patients in the window period can avoid the risk of missed detection because they only have virus antigens in their bodies and do not have corresponding antibodies or the corresponding antibody titers are not enough to be detected. Therefore,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/536G01N21/76
CPCG01N21/76G01N33/536G01N33/68G01N2333/186
Inventor 冯建敏赵文雅李会强刘宇卉李临
Owner CHEMCLIN DIAGNOSTICS CO LTD
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