Munus Medical Self-Test Helicobacter Pylori is an in vitro diagnostic medical device for the qualitative detection of Helicobacter pylori antigens in human stool samples.
Indications
Munus Medical Self-Test Helicobacter Pylori is an in vitro diagnostic medical device registered with the Ministry of Health No. 2391156.
A rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigens in human stool samples. It uses antibodies specific for H. pylori antigens to selectively detect H. pylori in human stool specimens.
In this test, the membrane is precoated with anti-H. pylori on the test line region. During testing, the sample reacts with the anti-H. pylori-coated particle. The mixture migrates upward on the membrane by capillary action to react with the anti-H. pylori on the membrane, generating a colored line.
The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that an adequate volume of specimen has been added and membrane wicking has occurred.
Instructions for Use
Wash your hands with soap and rinse with water.
The stool sample must be collected on stool collection paper or in clean collection containers. Use stool collection paper, avoiding contamination of the sample by taking precautions to ensure that the sample or the side of the paper containing the sample does not come into contact with contaminants, including toilet cleaners.
Unscrew the cap of the sample collection tube, then randomly insert the sample collection applicator into the stool sample in at least 3 different places. Do not collect the stool sample. Screw and tighten the cap on the sample collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer for 2 minutes.
Bring the pouch to room temperature before opening. Remove the test cassette from the foil pouch and use it as soon as possible. Best results are obtained if the test is performed immediately after opening the foil pouch.
Open the cap of the sample collection tube and break the tip. Invert the sample collection tube and transfer 2 full drops of the extracted sample into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S).
Read results after 10 minutes. Do not read results after 20 minutes.
Interpretation of Results
Positive: Two lines appear, the test line (T) and the control line (C). The intensity of the color in the test line (T) region will vary depending on the concentration of Helicobacter pylori antigen in the sample. Therefore, any shade of color in the test line region (T) should be considered positive. This result means that H. pylori antigen is present in the stool and you should consult a doctor.Negative: A colored line appears in the control line region (C). No line appears in the test line region (T). This result means that the presence of H. pylori in the stool is undetectable.Invalid: The control line (C) does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line (C) not appearing. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.Warnings
For in vitro diagnostic self-testing only. Do not use after the expiration date.Do not eat, drink, or smoke in the area where specimens or kits are handled.If the foil pouch is damaged or has been opened, do not use it.Use a clean container to collect the stool sample.Strictly follow the indicated times.Use the test only once. Do not disassemble or touch the test window of the test cassette.Dispose of the used test according to local regulations.Keep out of reach of children.The test should be used for the detection of H. pylori in stool samples only. Neither the quantitative value nor the rate of increase in H. pylori antigen concentration can be determined by this qualitative test.The test will only indicate the presence of Helicobacter pylori in the sample and should not be used as the sole diagnostic criterion for determining whether Helicobacter pylori is a causative agent for peptic or duodenal ulcers.Test results should be interpreted in conjunction with other clinical information available to the physician.If the test result is negative and clinical symptoms persist, further testing using other clinical methods is recommended. A negative result never precludes the possibility of H. pylori.Following some antibiotic treatments, the concentration of H. pylori antigens may decrease to a concentration below the minimum detection level of the test. Therefore, the diagnosis should be made with caution during antibiotic treatment.Format
1 test
Product Code:FRCM234197
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