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Kit for detecting helicobacter pylori antibody in human urine by colloidal gold method and preparation method thereof

A technology of Helicobacter pylori and colloidal gold test paper, which is applied in biological testing, measuring devices, immunoassays, etc., and can solve problems such as errors, samples or instruments that are easily contaminated, and unsuitable for pregnant women and children.

Pending Publication Date: 2021-05-18
BEIJING KANGMEI TIANHONG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are mainly the following methods for the detection of Helicobacter pylori in clinical practice: (1) Direct rapid urease test with gastroscope, biopsy specimens are affected by bacterial density, proton pump inhibitors, antibacterial drugs, etc., which may easily cause false negative results , and gastroscopy detection is painful for patients; (2) Gene detection (using PCR detection) is highly sensitive, simple, fast and highly specific, but PCR requires extremely high technology, and specimens or instruments are easy to be detected. Contamination caused erroneous results; (3)C 13 / 14 The breath test has the advantages of high accuracy and specific values, but it is expensive and requires fasting, and C 14 Belonging to radioactive isotopes, radioactive, not suitable for pregnant women and children

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1, preparation and effect verification of the kit provided by the present invention

[0050] 1. Preparation of kits

[0051] 1. Preparation of colloidal gold pads

[0052] Colloidal gold diluent: containing 0.8g / 100ml casein, 3g / 100ml sucrose, 3g / 100ml trehalose, 0.8g / 100ml Triton X-100, and the balance is Tris-HCl buffer solution (pH8.0, 50mM).

[0053] (1) Preparation of colloidal gold

[0054] Take 1g of gold chloride (powder) and dissolve it in 100ml of water to obtain a gold chloride solution. Take 1 g of sodium citrate dihydrate and dissolve it in 100 ml of water to obtain a sodium citrate solution.

[0055] Get the round bottom flask, add magnetic stirrer and about 1000ml ultrapure water, heat to water boiling, then discard the ultrapure water, leave the magnetic stirrer; add 955ml ultrapure water in the described round bottom flask and heat to water boiling , then quickly add 10ml gold chloride solution, add 10-14ml sodium citrate solution after 1...

Embodiment 2

[0126] Embodiment 2, the kit provided by the present invention detects the accuracy of a larger amount of samples

[0127] Of 200 volunteers, using the gold standard test, 108 breath tests were positive and 92 breath tests were negative.

[0128] The middle urine samples of the volunteers were taken and tested by the kit of the present invention, 99 of the 108 positive samples showed positive results, and 87 of the 92 negative samples showed negative results, with a coincidence rate of 93%.

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PUM

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Abstract

The invention discloses a kit for detecting a helicobacter pylori antibody in human urine by a colloidal gold method and a preparation method thereof. The kit provided by the invention comprises a colloidal gold test strip for detecting the helicobacter pylori antibody based on a double-antigen sandwich method and a sample diluent. The colloidal gold pad is coated with a colloidal gold labeled Hp antigen A; a line T of the detection pad is coated with an Hp antigen B; and the Hp antigen A and the Hp antigen B are helicobacter pylori matching antigens. The sample diluent is prepared from: 70-80 mM of Tris-HCl, 0.5-1 g / 100 ml of Tween 20, 0.5-1 g / 100 ml of PVP-K30 (Polyvinyl Pyrrolidone K30), 0.1-0.5 g / 100 ml of SDS (Sodium Dodecyl Sulfate), 0.8-0.9 g / 100 ml of NaCl and 0.04-0.06 g / 100 ml of prolin300. The kit provided by the invention can be used for detecting a urine sample, and compared with serum detection and sampling in the prior art, the kit provided by the invention is more convenient, painless and noninvasive.

Description

technical field [0001] The invention relates to the detection of Helicobacter pylori urease antibody, in particular to a kit for detecting the Helicobacter pylori antibody in human urine by a colloidal gold method and a preparation method thereof. Background technique [0002] In 1983, Australian scholars discovered a kind of arc-curved or S-curved microaerophilic bacteria that parasitized on the surface of gastric mucosa and deep layer of gastric mucus. Helicobacter pylori, referred to as Hp bacteria. It has been confirmed that Helicobacter pylori is the culprit of peptic ulcer (stomach ulcer, duodenal ulcer) and chronic active gastritis. Studies have shown that more than 90% of duodenal ulcers and more than 80% of gastric ulcers are caused by Hp infection is caused by Helicobacter pylori, and more than 60% of patients with chronic gastritis have Hp infection. Hp infection → chronic superficial gastritis → atrophic gastritis → intestinal metaplasia or atypical hyperplasia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/569G01N33/558G01N33/58
CPCG01N33/6854G01N33/56922G01N33/558G01N33/585G01N2469/20
Inventor 张枫张璇
Owner BEIJING KANGMEI TIANHONG BIOTECH
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