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Semi-quantitative pepsin detection product for distinguishing physiological and pathological reflux

A pepsin, semi-quantitative technique, applied in the medical and health field

Pending Publication Date: 2021-06-29
湖南优博思生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

According to the official website of NMPA, there is still no such clinically available medical device product approved for marketing

Method used

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  • Semi-quantitative pepsin detection product for distinguishing physiological and pathological reflux
  • Semi-quantitative pepsin detection product for distinguishing physiological and pathological reflux
  • Semi-quantitative pepsin detection product for distinguishing physiological and pathological reflux

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] A semi-quantitative pepsin detection product, including a pepsin detection device - colloidal gold pepsin detection test strip and pepsin standard substance concentration control: 0ng / ml, 5ng / ml, 10ng / ml, 25ng / ml, 50ng / ml, 100ng / ml and 200ng / ml pepsin standard concentration semi-quantitative standard color band.

[0018] The preparation method is as follows:

[0019] 1. Construction of pPICZαA vector for eukaryotic expression of pepsin

[0020] Using the nucleotide sequence corresponding to pepsin as a template, primers were designed. After PCR amplification, double enzyme digestion of the PCR product and the vector, the nucleotide sequence corresponding to pepsin was cloned into the pPICZαA vector, the obtained vector was transformed into Pichia pastoris, and then induced and cultivated.

[0021] 2. Eukaryotic expression of pepsin

[0022] Recombinant engineering yeast construction (pepsin) expression and screening,

[0023] Pepsin Fermentation Process

[0024] T...

Embodiment 2

[0060] Clinical evaluation of semi-quantitative pepsin detection products

[0061] The saliva of 20 clinical asymptomatic patients with physiological reflux and 25 saliva of pathological reflux patients collected from the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University were selected according to the hospital's biosafety management system. Three batches of continuous production under the quality management system: 202003001, 202003002, and 202003003 were randomly selected from the colloidal gold pepsin detection test strips for detection, and the test results were compared with the semi-quantitative standard color bands of the pepsin standard concentration to determine Detect the pepsin semi-quantitative concentration of the sample, and determine whether the test sample patient is physiological reflux or pathological reflux according to the pepsin semi-quantitative concentration of the test sample, and the pepsin semi-quantitat...

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Abstract

The invention provides a semi-quantitative pepsin detection product for distinguishing physiological and pathological reflux. The product comprises a device for detecting pepsin and a pepsin standard substance concentration contrast, the pepsin standard substance concentration contrast at least comprises a pepsin standard substance concentration contrast which is less than 50ng / ml and a pepsin standard substance concentration contrast which is not less than 50ng / ml. When the product provided by the invention is used for detecting the pepsin, the concentration of the pepsin is semi-quantitatively measured, so that the physiological reflux and pathological reflux are distinguished. The semi-quantitative pepsin detection product is high in detection rate and sensitivity and is simple to operate, and is verified by clinical practices and is suitable for further clinical popularization.

Description

technical field [0001] The invention belongs to the field of medical and health technology, in particular to the in vitro detection of LPR, and is especially suitable for the in vitro distinction and detection of physiological and pathological gastric reflux entering the hypopharynx (ie throat). Background technique [0002] LPR (pharyngitis reflux) refers to a class of diseases caused by the reflux of gastric contents to the throat. Otitis media is associated with dysphonia. GERD (gastroesophageal reflux disease) refers to the general term for gastroesophageal reflux and esophageal mucosal injury diseases caused by the reflux of the contents of the stomach and duodenum into the esophagus, and the esophageal mucosa is stimulated by gastric juice. [0003] LPR is correlated with GERD, and LPR is mostly an extraesophageal manifestation of GERD. LPR has always been classified as chronic pharyngitis, but LPR has its own unique characteristics in terms of etiology, symptoms and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/573G01N33/558G01N33/543C07K16/40
CPCG01N33/577G01N33/573G01N33/558G01N33/54346C07K16/40G01N2333/96477G01N2800/06Y02A50/30
Inventor 杨轶轩
Owner 湖南优博思生物技术有限公司
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