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Helicobacter Pylori Rapid Antigen Test Kit

        This product adopts the principle of double antibody sandwich assay for the qualitative detection of Helicobacter pylori (HP) antigen in human fecal samples. Monoclonal antibody to H. pylori is encapsulated on nitrocellulose membrane in the position of the detection line, and goat anti-mouse IgG is encapsulated in the position of the control line with latex microspheres labeled with monoclonal antibody to H. pylori. For testing, the sample reacts with the pre-coated latex microsphere-conjugated H. pylori monoclonal antibody. The mixture is then subsequently chromatographed upwards by capillary effect. In the case of a positive test, the microsphere-labeled H. pylori monoclonal antibody binds first to the H. pylori (HP) antigen in the sample during chromatography, and the conjugate is then bound by the H. pylori monoclonal antibody immobilized on the membrane, resulting in a red band at the detection line (T). If negative, there will be no red band at the detection line (T). A red band will appear at the control line (C) regardless of the presence of the test material in the sample. The red band presented at the control line (C) position is the criterion for determining whether there is enough sample and whether the chromatographic process is working properly, and also serves as an internal control standard for the reagent.
 
Test Specimen:Stool Sample.
Function:Early Detection.
Detection Method:Manul Self-test(IVD).
Certificate:CE
Specification: 1Test/2Tests/5Tests/20Tests Per Kit.
Storage:2℃~30℃.
Valid : 24 Months.
Sample:Available.
Availability:
Quantity:
  • ICA2227

  • Bioteke

Warm Warning:This Product Is Not Available For The US Market!

In addition, we are looking for global agents to jointly contribute to the development of human health. Looking forward to cooperating with you!

a.Intended use of the product.

      This product is designed for the in vitro qualitative detection of Helicobacter pylori antigen in human fecal samples.Helicobacter pylori (Hp),originally named Campylobacter pylori,is a gram-negative bacterium,arc-shaped or S- shaped,with 1-2 tiny curves and 4-6 unipolar or bipolar flagella with sheaths,is a microaerobic bacterium,and is the most active in reproduction at a pH of 6-8.After reaching the gastric mucosa through the mouth,H.pylori settles and infects the gastric mucosa,leading to chronic superficial gastritis in a few weeks or months,and then develops into duodenal ulcers,gastric ulcers,lymphoproliferative gastric lymphomas,and chronic atrophic gastritis in a few years or decades,which is the most risky factor for gastric cancer.The prevalence of infection is related to local public health conditions.In developed countries,the infection rate is 20%~40%,and in China,the infection rate is 21%~93%,50% in urban areas and 68.8% in suburban areas,and the infection rate of gastroscopy staff is 82.4%,which is significantly higher than that of other healthcare workers (66.4%).The main infectious channels and modes of transmission for Hp are the oral-oral and fecal-oral routes.There is a family aggregation of Helicobacter pylori (HP) infections,and children of parents who are positive for HP antibodies have a higher rate of positivity than those whose parents are negative.Laboratory diagnostic methods for H.pylori include microbial culture,pathologic testing,various nucleic acid amplification techniques,urea breath test,fecal antigen detection,and serologic tests (e.g.,enzyme-linked immunoassay and gold standard method).

H.p test kit (4)

b.Our helicobacter pylori antigen test kit has the following advantages.

1. Non-invasive: Compared with gastroscopy, antigen test kits detect antigens in stool or breath, without invasive procedures, and are more acceptable to patients.

2. Convenient and fast: Test kits are usually simple to operate and easy to use. You can take samples at home or quickly test them in clinics, which reduces waiting time.

3. Higher sensitivity and specificity: Modern antigen test kits have high sensitivity and specificity, which can accurately detect Helicobacter pylori infection and reduce false positive and false negative results. (See the attachment for product test results)

4. Low cost: Compared with gastroscopy and other methods, antigen testing is relatively low in cost, economical and suitable for large-scale screening and monitoring.

5. Applicable to all kinds of people: Antigen detection methods are suitable for children, the elderly and other people who are not suitable for invasive examinations.

6. Can be used for efficacy evaluation: During the treatment of Helicobacter pylori infection, antigen testing can be used to evaluate the treatment effect and monitor recurrence.

7. High safety: Since it does not involve invasive operations, it avoids the risks that may be caused by gastroscopy, such as bleeding and infection.

In summary, the Helicobacter pylori antigen detection kit has the advantages of non-invasiveness, convenience, high sensitivity and specificity, low cost, wide applicability and high safety. It is an effective tool for detecting Helicobacter pylori infection.

H.p test kit (6)

c.Testing process.

SPECIMEN REQUIREMENTS

1. Fresh fecal samples. Formed or unformed fecal samples of different types may be used, and the collection requirements are the same if there is no requirement for the time of collection. Samples should be collected without mixing water and urine, disinfectants and sewage. 

2. Sample storage: Stool samples should be stored in clean, dry containers free of preservatives and detergents for not more than 4 hours at room temperature and not more than 48 hours at 2°C to 8°C. Refrigerated samples need to be brought back to room temperature before testing.

procedure h. pylori


d.Interpretation of results.

results

H.p test kit (8)

【Positive】Both "C" and "T" show red lines. The lines at "T" can be dark or light in color, both indicate positive results. 2 / 33 / 3 

【Negative】Red line presents at 'C', no line at 'T'. 

【Invalid】No red line presents at 'C', regardless of whether line presents at 'T', the result is invalid and you should retest by with a new test card.


e.Precautions. 

1. This reagent is intended for in vitro diagnostic use only. 

2. This reagent is intended for the detection of H. pylori antigen in human fecal samples only and provides a preliminary analytical result. 

3. The reagent can be stored at room temperature, beware of moisture. Reagents stored at low temperatures should be equilibrated to room temperature before use. 

4. The degree of coloration of the test line does not necessarily correlate with the titer of the test substance in the sample. Clinical samples, laboratory waste, single-use articles and other materials contacted during the test should be treated as potentially infectious. 

5. This is a single-use product.


f.About Bioteke Corporation

Bioteke Corporation, founded in 2005, has been committed to the research and development of life science instruments and diagnostic kits. Its products cover scientific research, clinical and diagnostics. It has established R&D bases in Beijing and Wuxi, and factories in Wuxi, Jiangyin and Taizhou, covering an area of more than 50,000 square meters.

We currently have more than 30 patented technologies and have won honorary certificates issued by the national and local governments many times; we also have ISO13485:2006 certificates, some products have IVDD registration certificates, and all products can provide CE certificates and third-party test reports.

Our customers are all over the world, and our products are increasingly praised by friends around the world. We have always focused on providing customers with high-quality and low-priced products, and at the same time, we care more about life.

We welcome friends from all over the world to work with us to develop the cause of human health.

Bioteke





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