Descrizione Clinica
SCREEN
CHECK TEST
Antigen H. PyloriDescription
CE 0123 in vitro diagnostic medical device.
Quick test for qualitative detection of Helicobacter pylori antigens (H. pylori) in human feces.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas with excessive humidity. If the sealed package is damaged or open, please do not use the test.
4. Use a clean container to collect the fecal sample.
5. Carefully observe the times indicated.
6. Use the test only once.
7. Do not disassemble or touch the test window on the support.
8. The kit should not be frozen or used over the printed expiration date on the package.
9. After use, all components must be thrown with the normal household trash.
10. Keep out of reach of children.
Mode of use
1. Wash your hands with soap and rinse with clean water.
2. For fecal samples collection: the fecal sample should be collected in the fecal collection sheet or in a clean container. Please use the fecal collection sheet, avoiding sample contamination by taking the necessary precautions so that the sample or paper side containing the sample does not come into contact with other contaminants including bath products.
3. To analyze fecal samples: unscrew the sample harvester cap, then randomly infiltrate the sample collected with the applicator in the fecal sample at at least 3 different points. Don't shake the fecal sample. Reboot and secure the cap on the harvesting test, then shake the sample harvesting test vigorously to mix the sample and extraction buffer.
4. Bring the packaging to room temperature before opening it. Remove the test device from the sealed package and use it as soon as possible. Better results are obtained if the test is performed immediately after opening the package.
5. Open the cap on the sample collection test and break the tip. Rotate the test tube and pour 2 full drops of the sample extracted into the sample pot (S) on the test device, then start the timer. Avoid trapped air bubbles in the sample cockpit (S).
6. Read the results 10 minutes. Do not read the results after 20 minutes.
Reading results
POSITIVE*: two lines appear. Both the T (Test) and C (Control). This result indicates the presence of H. pylori antigen in the feces and you should consult a doctor.
NEGATIVO: a coloured line appears in the control area (C). No line appears in the test zone (T). This result indicates that it was not possible to detect the presence of H. pylori antigen in the feces.
NULLO: the control line does not appear. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
*The color intensity in the test zone (T) varies depending on the concentration of antigen H. pylori present in the sample. Therefore, any color gradation of the test line (T) is to be considered positive.
Limits
1. The H. pylori antigen test (Feci) is only for in vitro diagnostic use. The test should only be used to detect H. pylori antigens in stool samples. This qualitative test does not determine either the quantitative value or the growth rate of H. pylori antigen concentration.
2. The H. pylori antigen test (Feci) will indicate only the presence of H. pylori in the sample and should not be used as the only criterion to establish that theH.pylori is the etiological agent of peptic or duodenal ulcers.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the doctor.
4. If the test result is negative and clinical symptoms persist, further tests are recommended using other clinical methods. A negative result does not in any way exclude the possibility of an H. pylori infection.
5. Following some antibiotic treatments, the concentration of antigens H. pylori can decrease below the minimum level of detection of the test. Therefore diagnosis during antibiotic treatment should be made with caution.
Conservation
The kit can be stored at room temperature or refrigerated (2-30°C).
The test is stable until the expiry date printed on the sealed package.
The test must remain in the sealed packaging until the time of use.
DON'T CONGEL. Do not use beyond the expiry date.
Format
Pack containing 1 piece.
BIBLIOGRAPHY:
1. Marshall, BJ, McGechie, DB, Rogers, PAR and Glancy, RG. Pyloric Campylobacter infection and gastroduodenal disease. J. Australia Med. (1985), 149: 439-44.
2. Soll, AH. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med. (1990), 322: 909-16.
3. Hazell, SL, et al. Campylobacter pylori is and gastritis I: Detection of urease as a marker of bacterial colonization and gastritis. J. Gastroenterology. (1987), 82(4): 292-96.
4. Cutler AF. Testing for Helicobacter pylori in clinical practice. Am J. Med. 1996; 100:35S-41S.
5. Anand BS, Raed AK, Malaty HM, et al. Loe point prevalence of peptic ulcer in normal individual with Helicobacter pylori infection. Am J Gastroenterol. 1996,91:1112-1115.
CE 0123 in vitro diagnostic medical device.
Quick test for qualitative detection of Helicobacter pylori antigens (H. pylori) in human feces.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas with excessive humidity. If the sealed package is damaged or open, please do not use the test.
4. Use a clean container to collect the fecal sample.
5. Carefully observe the times indicated.
6. Use the test only once.
7. Do not disassemble or touch the test window on the support.
8. The kit should not be frozen or used over the printed expiration date on the package.
9. After use, all components must be thrown with the normal household trash.
10. Keep out of reach of children.
Mode of use
1. Wash your hands with soap and rinse with clean water.
2. For fecal samples collection: the fecal sample should be collected in the fecal collection sheet or in a clean container. Please use the fecal collection sheet, avoiding sample contamination by taking the necessary precautions so that the sample or paper side containing the sample does not come into contact with other contaminants including bath products.
3. To analyze fecal samples: unscrew the sample harvester cap, then randomly infiltrate the sample collected with the applicator in the fecal sample at at least 3 different points. Don't shake the fecal sample. Reboot and secure the cap on the harvesting test, then shake the sample harvesting test vigorously to mix the sample and extraction buffer.
4. Bring the packaging to room temperature before opening it. Remove the test device from the sealed package and use it as soon as possible. Better results are obtained if the test is performed immediately after opening the package.
5. Open the cap on the sample collection test and break the tip. Rotate the test tube and pour 2 full drops of the sample extracted into the sample pot (S) on the test device, then start the timer. Avoid trapped air bubbles in the sample cockpit (S).
6. Read the results 10 minutes. Do not read the results after 20 minutes.
Reading results
POSITIVE*: two lines appear. Both the T (Test) and C (Control). This result indicates the presence of H. pylori antigen in the feces and you should consult a doctor.
NEGATIVO: a coloured line appears in the control area (C). No line appears in the test zone (T). This result indicates that it was not possible to detect the presence of H. pylori antigen in the feces.
NULLO: the control line does not appear. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
*The color intensity in the test zone (T) varies depending on the concentration of antigen H. pylori present in the sample. Therefore, any color gradation of the test line (T) is to be considered positive.
Limits
1. The H. pylori antigen test (Feci) is only for in vitro diagnostic use. The test should only be used to detect H. pylori antigens in stool samples. This qualitative test does not determine either the quantitative value or the growth rate of H. pylori antigen concentration.
2. The H. pylori antigen test (Feci) will indicate only the presence of H. pylori in the sample and should not be used as the only criterion to establish that theH.pylori is the etiological agent of peptic or duodenal ulcers.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the doctor.
4. If the test result is negative and clinical symptoms persist, further tests are recommended using other clinical methods. A negative result does not in any way exclude the possibility of an H. pylori infection.
5. Following some antibiotic treatments, the concentration of antigens H. pylori can decrease below the minimum level of detection of the test. Therefore diagnosis during antibiotic treatment should be made with caution.
Conservation
The kit can be stored at room temperature or refrigerated (2-30°C).
The test is stable until the expiry date printed on the sealed package.
The test must remain in the sealed packaging until the time of use.
DON'T CONGEL. Do not use beyond the expiry date.
Format
Pack containing 1 piece.
BIBLIOGRAPHY:
1. Marshall, BJ, McGechie, DB, Rogers, PAR and Glancy, RG. Pyloric Campylobacter infection and gastroduodenal disease. J. Australia Med. (1985), 149: 439-44.
2. Soll, AH. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med. (1990), 322: 909-16.
3. Hazell, SL, et al. Campylobacter pylori is and gastritis I: Detection of urease as a marker of bacterial colonization and gastritis. J. Gastroenterology. (1987), 82(4): 292-96.
4. Cutler AF. Testing for Helicobacter pylori in clinical practice. Am J. Med. 1996; 100:35S-41S.
5. Anand BS, Raed AK, Malaty HM, et al. Loe point prevalence of peptic ulcer in normal individual with Helicobacter pylori infection. Am J Gastroenterol. 1996,91:1112-1115.
