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Pepsinogen I and pepsinogen II combined detection kit and application thereof

A pepsinogen and combined detection technology, which is applied in the field of pepsinogen Ⅰ and pepsinogen Ⅱ combined detection kits, can solve the problems of time-consuming and laborious work, cumbersome work, and the inability to realize multi-index simultaneous detection, so as to shorten the time and reduce the The cost of testing and the effect of stable and reliable testing results

Pending Publication Date: 2020-07-10
北京清分稳同科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the current immunoassay technology, whether it is the earliest radioimmunoassay (RIA) or the non-radioactive immunoassay methods gradually developed later, such as enzyme-linked immunoassay (ELISA) and chemiluminescence immunoassay (CLIA), each detection Only one disease marker can be obtained at a time. If multiple disease markers need to be detected, serum samples should be added to multiple small holes for reaction and detection. The work is cumbersome, time-consuming and laborious, and it is impossible to achieve multiple indicators simultaneously Detection analysis

Method used

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  • Pepsinogen I and pepsinogen II combined detection kit and application thereof
  • Pepsinogen I and pepsinogen II combined detection kit and application thereof
  • Pepsinogen I and pepsinogen II combined detection kit and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Pepsinogen I (PGI) and Pepsinogen II (PGII) Combined Detection Kit

[0051] 1. Pepsinogen Ⅰ (PG Ⅰ) and Pepsinogen Ⅱ (PG Ⅱ) combined detection kit consists of the following components:

[0052] Magnetic beads coated with anti-PGⅠ monoclonal antibody (PGⅠ8015 antibody) and magnetic beads coated with anti-PGⅡ monoclonal antibody (PGⅡ8101 antibody);

[0053] Rare earth element thulium (Tm) labeled anti-PGⅠ monoclonal antibody (PGⅠ8003 antibody) and rare earth element lutetium (Lu) labeled anti-PGⅡ monoclonal antibody (PGⅡ8103 antibody);

[0054] PG composite calibrator;

[0055] PG composite quality control;

[0056] Dissociation solution;

[0057] Immunowashing solution.

[0058] The preparation method of above-mentioned each component is as follows:

[0059] 1. The preparation method of magnetic beads coated with anti-PGⅠ monoclonal antibody (PGⅠ8015 antibody) and magnetic beads coated with anti-PGⅡ monoclonal antibody (PGⅡ8101 antibody), comprising the fol...

Embodiment 2

[0103] Example 2 Performance testing and application of pepsinogen Ⅰ (PGⅠ) and pepsinogen Ⅱ (PGⅡ) combined detection kit

[0104] 1. Performance indicators

[0105] 1. Minimum detection limit

[0106] According to "step B in the step 2 in embodiment 1) detection test sample method", detect with zero concentration PG composite calibrator solution (i.e. PG composite calibrator solution A in the embodiment) as the sample to be tested, repeat detection 20 times, Obtain the response value of the 20 detection results-the corresponding ion count value per second (cps), calculate the mean (M) and standard deviation (SD), and obtain M+2SD. The adjacent concentration PG composite calibrator solution (i.e. PG composite calibrator solution B) is used as the sample to be tested for detection, the detection is repeated 3 times, and the average value is taken to obtain the response value-corresponding ion counts per second (cps).

[0107] According to the concentration-cps results between ...

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Abstract

The invention discloses a pepsinogen I and pepsinogen II combined detection kit and application thereof. The invention discloses a pepsinogen I and II combined detection kit for the first time. The pepsinogen I and II combined detection kit comprises a coating antibody and a labeled antibody, wherein the coating antibody is an anti-PGI monoclonal antibody named as a monoclonal antibody IA and an anti-PGII monoclonal antibody named as a monoclonal antibody IIA; wherein the labeled antibody is an anti-PG I monoclonal antibody named as a monoclonal antibody IB and an anti-PG II monoclonal antibody named as a monoclonal antibody IIB. The invention further discloses application of the kit. According to the invention, the pepsinogen I and II combined detection kit is combined with a high-sensitivity inductively coupled plasma mass spectrometry detection technology on the basis of time-resolved fluorescence immunoassay. Detection of two indexes of PGI and PGII can be completed at the same time in one cycle, the time for clinically obtaining a PGI value and a PGI / PGII ratio result is shortened, and the detection cost is greatly reduced.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic reagents, in particular to a combined detection kit for pepsinogen I and pepsinogen II and an application thereof. Background technique [0002] Gastric cancer is one of the most common malignant tumors, and the death rate of gastric cancer ranks second in the mortality rate of common malignant tumors worldwide. Early detection, early diagnosis, and early treatment are one of the key measures to reduce the mortality rate of gastric cancer. At present, the diagnosis of gastric cancer and other gastric diseases still relies on gastroscopy and histopathology. However, gastroscopy is painful and often not accepted by patients, which easily leads to delays in diagnosis and treatment. [0003] In recent years, the relationship between serum pepsinogen Ⅰ (PGⅡ) and pepsinogen Ⅱ (PGⅡ) content changes and their ratio (PGⅠ / PGⅡ) and gastric diseases and its role in the early diagnosis of gastric ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/573G01N33/543
CPCG01N33/577G01N33/573G01N33/54326G01N2333/96477G01N2800/06
Inventor 盛琳峰刘华
Owner 北京清分稳同科技有限公司
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