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ICA2227
Bioteke
Intended Use
This product is designed for the in vitro qualitative detection of Helicobacter pylori (HP) antigen in human fecal samples.
Applicable Scenorios
Community health and primary care clinics.
Health checkup center.
Pharmacy and home self-testing.
Digestive tract disease screening.
Preoperative examination.
Materials Provided
Product 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.
Necessity of H. P Testing
Close association between Helicobacter pylori and gastrointestinal diseases
1. Chronic gastritis
2. Peptic ulcer (gastric ulcer and duodenal ulcer)
3. Gastric cancer
4. Gastric mucosa-associated lymphoid tissue (MALT) lymphoma
High incidence and hidden nature of Helicobacter pylori infection
1. High infection rate
2. Asymptomatic carriers
Guiding clinical treatment and evaluating treatment effects
1. Guiding clinical treatment
2. Evaluation after treatment
Reduce the risk of complications and cancer
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.
Interpretation of Results.
【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.
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.
Comparison of different detection methods for Helicobacter Pylori.
Intended Use
This product is designed for the in vitro qualitative detection of Helicobacter pylori (HP) antigen in human fecal samples.
Applicable Scenorios
Community health and primary care clinics.
Health checkup center.
Pharmacy and home self-testing.
Digestive tract disease screening.
Preoperative examination.
Materials Provided
Product 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.
Necessity of H. P Testing
Close association between Helicobacter pylori and gastrointestinal diseases
1. Chronic gastritis
2. Peptic ulcer (gastric ulcer and duodenal ulcer)
3. Gastric cancer
4. Gastric mucosa-associated lymphoid tissue (MALT) lymphoma
High incidence and hidden nature of Helicobacter pylori infection
1. High infection rate
2. Asymptomatic carriers
Guiding clinical treatment and evaluating treatment effects
1. Guiding clinical treatment
2. Evaluation after treatment
Reduce the risk of complications and cancer
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.
Interpretation of Results.
【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.
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.
Comparison of different detection methods for Helicobacter Pylori.
