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A composite quality control product for clinical diagnosis and preparation method thereof

A technology for clinical diagnosis and quality control products, applied in the field of quality control products for immunodiagnostic reagents, can solve the problems of low production efficiency and singleness, achieve the effects of large molecular weight of ferritin, avoid repeated operations, and reduce production costs

Active Publication Date: 2021-05-11
南京佰抗生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the defect that the quality control product of the immunodiagnostic reagent in the prior art is a single item quality control product and the preparation efficiency is low, and to provide a composite quality control product

Method used

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  • A composite quality control product for clinical diagnosis and preparation method thereof
  • A composite quality control product for clinical diagnosis and preparation method thereof
  • A composite quality control product for clinical diagnosis and preparation method thereof

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Embodiment

[0021] A composite quality control product for clinical diagnosis, comprising ferritin and several diagnostic marker-specific epitope polypeptide molecules linked to ferritin by linking esters.

[0022] Ferritin is a spherical polymer formed by self-assembly of 24 monomers. It is a nanoparticle protein with a very stable molecular structure. The C, N terminal and loop zone can all be used to insert foreign gene fragments, and foreign polypeptides or proteins can be inserted Stably displayed on the surface of spherical particles, based on the above principles, ferritin carriers have been widely concerned in the fields of nanoparticle vaccine carriers, drug delivery, and in vivo imaging. In this study, we used molecular biology methods to tandem the dominant epitope sequence of multiple diagnostic markers to ferritin at the gene level, and expressed the ferritin complex containing the dominant epitopes of multiple diagnostic markers using the prokaryotic Escherichia coli expressi...

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Abstract

The invention discloses a composite quality control product based on multiple diagnostic marker-specific epitope polypeptide molecules linked by ferritin nanoparticle carriers and a preparation method thereof. Through antibody detection and epitope analysis techniques, most of the The dominant epitope of the diagnostic marker protein is located, and then linked to the ferritin molecule by connecting esters to form a "Fer-Linker-Epitope Peptide" complex, and the synthetic gene sequence of the complex is transferred into the prokaryotic large intestine through a specific vector Bacillus recombinant expression, so that the composite antigen (quality control product) containing the dominant epitope polypeptide molecules of multiple diagnostic markers can be detected by multiple diagnostic reagents at the same time. The quality control product of the invention has high detection efficiency, low cost and excellent stability, and can be stored stably for a long time under the condition of 2-8°C.

Description

technical field [0001] The invention relates to the technical field of quality control products for immunodiagnostic reagents, in particular to a composite quality control product for clinical diagnosis and a preparation method thereof. Background technique [0002] In my country, in vitro diagnostic reagents refer to: can be used alone or in combination with instruments, appliances, equipment or systems, in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and prediction of genetic diseases. Reagents, kits, calibrators (materials), quality control products (materials), etc. for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.). [0003] Quality control products are an important and essential part of in vitro diagnostic reagents, mainly used for quality control of in vitro diagnostic reagents. In the actual clinical application process, inspectors use in vitro diagnostic re...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K19/00C12N15/70G01N33/531G01N33/543G01N33/68G01N33/72G01N33/74
CPCC07K14/47C07K14/4737C07K14/5412C07K14/58C07K14/585C07K14/805C07K2319/00C12N9/6481C12N15/70C12N2800/22G01N33/531G01N33/54346G01N33/6854G01N33/72G01N33/74G01N2333/4737G01N2333/5412G01N2333/58G01N2333/585G01N2333/805G01N2333/96477
Inventor 芮兵
Owner 南京佰抗生物科技有限公司
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