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Tuberculosis diagnosis kit and fabrication method thereof

A diagnostic kit and tuberculosis technology, applied in the field of medical testing, can solve the problems of high false positive and low sensitivity of the kit, and achieve the effect of broadening the detection range, high sensitivity and high sensitivity

Pending Publication Date: 2019-12-20
南京拜睿生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the rapid development of molecular biology techniques, immunodiagnostic techniques for detecting tuberculosis antibodies in serum have the advantages of simplicity, quickness, no need for sophisticated instruments, and easy promotion. However, some kits have problems such as high false positives and low sensitivity.

Method used

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  • Tuberculosis diagnosis kit and fabrication method thereof

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Experimental program
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Effect test

Embodiment 1

[0019] Coat streptavidin with superparamagnetic magnetic balls; prepare positive control serum of tuberculosis patients and normal control serum; prepare recombinant antigen protein, label recombinant antigen protein with biotin; label recombinant antigen protein with alkaline phosphatase; prepare Concentrate wash solution and substrate solution; aliquot the above samples and assemble into finished products.

[0020] Wherein, the recombinant antigen protein is ESAT-6-connecting peptide-38KD, and the connecting peptide is a short peptide that does not affect the immunogenicity of ESAT-6 and 38KD.

[0021] Wherein, the specific method of streptavidin coating superparamagnetic magnetic ball is:

[0022] S1, mix PBS buffer solution and streptavidin to make coating solution;

[0023] S2. Take the original solution of the magnetic beads, take the reaction buffer solution to wash the magnetic beads, then resuspend them in the coating solution, and react overnight at 5°C;

[0024] S...

Embodiment 2

[0026] Coat streptavidin with superparamagnetic magnetic balls; prepare tuberculosis patient positive control serum and normal control serum; prepare recombinant antigen protein, label recombinant antigen protein with biotin; label recombinant antigen protein with acridinium ester; prepare concentrated Wash solution and substrate solution; aliquot the above samples and assemble into finished products.

[0027] Wherein, the recombinant antigenic protein is ESAT-6-connecting peptide-CPF-10, and the connecting peptide is a short peptide that does not affect the immunogenicity of ESAT-6 and CPF-10.

[0028] Wherein, the specific method of streptavidin coating superparamagnetic magnetic ball is:

[0029] S1, mix PBS buffer solution and streptavidin to make coating solution;

[0030] S2. Take the original solution of the magnetic beads, take the reaction buffer solution to wash the magnetic beads, then resuspend them in the coating solution, and react overnight at 5°C;

[0031] S3...

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Abstract

The invention provides a tuberculosis diagnosis kit and a fabrication method thereof, and belongs to the technical field of medical detection. The kit comprises a streptavidin-coated solid-phase carrier, a biotin-labeled antigen, a light-emitting substance-labeled antigen, tuberculosis positive control serum, normal person contrast serum, a concentrated scrubbing solution and a substrate liquid, wherein the solid-phase carrier is a superparamagnetic bead, and a tubercle bacillus antigene is recombined antigen protein. The kit employs the streptavidin-coated solid-phase carrier, relatively highaffinity is achieved between streptavidin and biotin, more light-emitting substances also can be combined, amplification of a detection signal is facilitated, and the analysis sensitivity is improved. With the adoption of the recombined antigen protein, compared with a conventional antigen method, the kit has higher sensitivity, and the detection range is also favorably expanded.

Description

technical field [0001] The invention belongs to the technical field of medical detection, and in particular relates to a tuberculosis diagnostic kit and a preparation method thereof. Background technique [0002] Tuberculosis is one of the most important infectious diseases in the world. About one-third of the world's population is infected with mycobacterium conjugation. There are about 9-10 million new cases every year, and about 1.8 million people die of tuberculosis. The number of tuberculosis patients in my country It ranks third in the world and is listed by WHO as one of the 22 countries with high burden of tuberculosis in the world. [0003] At present, the diagnosis of tuberculosis is mainly based on clinical symptoms, chest X-ray film and bacteriological examination. For example, tuberculosis smear examination is simple and easy, but the positive rate is low, while tuberculosis culture test results are highly reliable, but time-consuming , can not meet the clinical...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/535
CPCG01N33/5695G01N33/535
Inventor 张代民张立竹张玉虎洪涛
Owner 南京拜睿生物科技有限公司
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