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Combined serum marker detection reagent for screening and diagnosis of tuberculosis

A technology for detection reagents and detection kits, which is applied in the fields of biomedicine and clinical diagnosis, can solve the problems of difficult standardization of sample processing, unstable sample components, and difficulty in obtaining effective samples, so as to simplify the composition and detection operation process and facilitate industrialization The effect of promoting and reducing testing costs

Inactive Publication Date: 2018-10-23
北京睿达时代科技有限公司
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Problems solved by technology

[0007] In order to overcome the shortcomings of existing tuberculosis diagnostic methods such as low sensitivity, unsatisfactory accuracy, long detection time, difficulty in obtaining valid samples, narrow applicable population, unstable sample components, difficult standardization of sample processing, and high detection costs

Method used

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  • Combined serum marker detection reagent for screening and diagnosis of tuberculosis

Examples

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Embodiment 1

[0021] Example 1: Tuberculosis Screening Test

[0022] Study population: people with suspicious symptoms of tuberculosis who need differential diagnosis of tuberculosis (those with cough symptoms for more than 2 weeks);

[0023] Included sample size: 300 subjects;

[0024] Test samples: subjects' blood samples (300 in total);

[0025] Detection method: 71 serum markers in each blood sample were quantitatively tested by Single Molecule Array (SiMOA), and the Mycobacterium tuberculosis Ag85B antibody was quantitatively detected by Bead Array method;

[0026] Result analysis: use the machine learning method (TreeNet: Stochastic Gradient Boosting) to analyze the test results;

[0027] Test results: It was found that only the combination of Mycobacterium tuberculosis Ag85B antibody and four serum markers of interleukin-6 (IL-6), interleukin-8 (IL-8) and interleukin-18 (IL-18) can detect The results can reach the detection target of clinical use (see attached figure 1 ).

[002...

Embodiment 2

[0034] Example 2: Tuberculosis Screening Expanded Trial

[0035] Based on the results of Example 1, we verified on a larger sample.

[0036] The population included in the study: tuberculosis patients from multiple countries and those with suspicious symptoms of tuberculosis who need to be differentially diagnosed with tuberculosis;

[0037] Included sample size: 583 subjects, including 278 patients diagnosed with tuberculosis and 305 non-tuberculosis patients;

[0038] Test samples: subjects' blood samples (583 in total);

[0039] Detection method: Quantitative detection of serum markers in each blood sample by single molecule protein array detection method (Single Molecule Array, SiMOA);

[0040] Result analysis: use the machine learning method (TreeNet: Stochastic Gradient Boosting) to analyze the test results;

[0041] Test results: The results confirmed that only the combination of Mycobacterium tuberculosis Ag85B antibody and four serum markers of interleukin-6 (IL-6), ...

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Abstract

The invention relates to the technical fields of biomedicine and clinical diagnosis, and discloses a combined serum marker detection reagent for the screening and diagnosis of tuberculosis and applications thereof in screening and diagnosis of tuberculosis and treatment reaction monitoring. The detection reagent is composed of detection reagents for simultaneously detecting four serum markers: a mycobacterium tuberculosis Ag85B antibody, interleukin-6, interleukin-8, and interleukin-18. The detection reagent is suitable for ELISA (enzyme-linked immuno-sorbent assay), a Luminex based multi-analytic spectrum analysis method, a single molecule protein array detection method, side-stream immunoassay, and an aptamer technology. The provided detection reagent has the characteristics of wide application range, convenient and fast application, accurate result, and low detection cost. The clinical test results show that the accuracy of tuberculosis diagnosis completely meets the requirements oftuberculosis screening of WHO, when the detection reagent is used to screen tuberculosis.

Description

technical field [0001] The invention relates to the technical fields of biomedicine and clinical diagnosis, in particular to a combined serum marker detection reagent for tuberculosis screening and diagnosis and its application in clinical treatment. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis infection. Mycobacterium tuberculosis may invade various organs of the human body, but mainly invades the lungs, which is called tuberculosis. As the number one infectious disease in the world today, tuberculosis infects 2 billion people every year, and the number of patients who die from tuberculosis is no less than 1.5 million, and its death toll is still higher than any other infectious disease, leading to this situation One of the important reasons for the spread of tuberculosis is that it is very difficult to prevent because tuberculosis is transmitted by droplets and spreads very fast. Therefore, rapid and accu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/68
CPCG01N33/53G01N33/6893
Inventor 杜建刘宇红张峣鲁迪迈
Owner 北京睿达时代科技有限公司
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