Composite quality control product for gastric function detection and detection kit

A technology for detection kits and quality control products, which is applied in the field of biochemical detection, can solve the problems that have not yet been achieved, and achieve the effects of stable shelf life, convenient use, and product stability requirements

Inactive Publication Date: 2020-04-17
深圳市蔚景生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And there is no compound quality control product of pepsinogen I (PGI), pepsinogen II (PGII) and gastrin 17 (G17) on the market

Method used

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  • Composite quality control product for gastric function detection and detection kit
  • Composite quality control product for gastric function detection and detection kit
  • Composite quality control product for gastric function detection and detection kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] In this example, the protein preservation solution of the following formula was used to prepare the composite quality control substance of pepsinogen I, pepsinogen II and gastrin-17. The protein preservation solution is prepared by dissolving and mixing various components with purified water, and the pH is 6.5±0.2.

[0052]

[0053] Add pepsinogen I (PGI) antigen, pepsinogen II (PGII) antigen and gastrin-17 (G17) antigen to the protein preservation solution to prepare two composite quality control products with high value and low value, of which The low-value composite quality control contains PGI 40ng / mL, PGII 10ng / mL, and G17 40pg / mL, and the high-value composite quality control contains PGI 80ng / mL, PGII 30ng / mL, and G17100pg / mL. The two prepared composite quality control products were subjected to accelerated stability test at 37°C. On day 0, day 7 and day 14, horseradish peroxidase (HRP)-labeled anti-PGI antibody, HRP-labeled anti-PGII antibody and HRP-labeled ...

Embodiment 2

[0095] In this example, the protein preservation solution of the following formula was used to prepare the composite quality control substance of pepsinogen I, pepsinogen II and gastrin-17. The protein preservation solution is prepared by dissolving and mixing various components with purified water, and the pH is 6.5±0.2.

[0096]

[0097] Add pepsinogen I (PGI) antigen, pepsinogen II (PGII) antigen and gastrin-17 (G17) antigen to the protein preservation solution to prepare two composite quality control products with high value and low value, of which The low-value composite quality control contains PGI 40ng / mL, PGII 10ng / mL, and G17 40pg / mL, and the high-value composite quality control contains PGI80ng / mL, PGII 30ng / mL, and G17100pg / mL. The two prepared composite quality control products were subjected to an accelerated stability test at 37°C, and tested according to the method of Example 1. The test results were displayed in a list according to PGI, PGII and G17, and the...

Embodiment 3

[0106] In this example, the protein preservation solution of Example 1 is used, and pepsinogen I (PGI) antigen, pepsinogen II (PGII) antigen and gastrin-17 (G17) antigen are added to the protein preservation solution to prepare low The low-value composite quality control contains PGI 40ng / mL, PGII 10ng / mL, and G17 40pg / mL, and the high-value composite quality control contains PGI 80ng / mL and PGII 30ng / mL , G17 100pg / mL. The two prepared composite quality control products were subjected to a 14-month long-term stability test at 2-8°C to investigate the accuracy, uniformity in the bottle and uniformity between bottles. The specific method is as follows:

[0107] 1. Accuracy

[0108] According to the instructions of the instrument and kit, measure the calibrator and obtain the standard curve. Determine the quality control product to be tested, repeat the measurement 3 times, convert the concentration values ​​of the 3 measurements according to the standard curve, and calculate...

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Abstract

The invention relates to a pepsinogen I, pepsinogen II and gastrin-17 composite quality control product. The composite quality control material comprises a protein preserving solution, and pepsinogenI, pepsinogen II and gastrin-17 which are dissolved in the protein preserving solution, wherein the total volume of the protein preserving solution is calculated; wherein the protein preserving solution contains 0.8 to 3.5 g/L of AEP-HBC, 0.002 to 0.006 g/L of fibrinogen, 0.05 to 0.15 g/L of gelatin, 2 to 8 g/L of trehalose, 0.05 to 0.25 g/L of tetrapolyphosphate, 5-25 mmol/L of 2-(N-morpholine) ethanesulfonic acid, 0.5-4 g/L of ethylenediaminetetraacetic acid or ethylenediaminetetraacetic acid salt, 1-20 mmol/L of cysteine, methionine or arginine and 0.05-0.10% of a preservative,. The pepsinogen I, pepsinogen II and gastrin-17 composite quality control product is initiated at home, and can be stably stored for 14 months at the temperature of 2-8 DEG C. The invention further discloses a preparation method of the pepsinogen I, pepsinogen II and gastrin-17 composite quality control product. The invention also provides a detection kit containing the composite quality control product, andthe detection kit can be used for clinical detection of gastric functions.

Description

technical field [0001] The invention relates to the technical field of biochemical detection, in particular to a stable pepsinogen I (PGI), pepsinogen II (PGII) and gastrin 17 (G17) composite quality control product for gastric function detection, and also relates to A detection kit containing the composite quality control, such as a chemiluminescent detection kit or an enzyme-linked immunological detection kit. Background technique [0002] Gastric cancer is one of the most common digestive tract tumors, which seriously endangers human life and health. Poor dietary structure, unhealthy living and eating habits, and chronic infection of Helicobacter pylori (H. pylori) may be risk factors for high incidence of gastric cancer. With the improvement of people's living conditions, the formation of good eating habits, and the development of Helicobacter pylori therapeutic drugs and other factors, the incidence of gastric cancer has generally declined, but its incidence rate is st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N33/74G01N33/573
CPCG01N33/96G01N33/74G01N33/573G01N2333/595G01N2333/96477G01N2800/60
Inventor 王亚磊董婷
Owner 深圳市蔚景生物科技有限公司
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