Helicobacter pylori test - disposable test for self-testing

Product Description

Rapid test for the detection of Helicobacter pylori in stool.

Indications

The Helicobacter Pylori Test from Sofarmapiù is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter Pylori antigens in human stool samples, providing results in 10 minutes. In the test, the membrane is precoated with anti-Helicobacter pylori on the test line region. During the test, the sample reacts with the anti-Helicobacter pylori antibody particle. The mixture migrates upward on the membrane by capillary action to react with the anti-Helicobacter pylori on the membrane, generating a colored line. The presence of this colored line in the test 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.

Directions for Use

Before performing the test, stool samples must be collected according to the instructions. Wash your hands with soap and rinse with water.

Sample Collection

The stool sample must be collected on stool collection paper or in clean collection containers. Use stool collection paper, avoiding contamination of the specimen by taking precautions to ensure that the specimen is clean and hygienic. The sample or the side of the paper containing the sample does not come into contact with contaminants, including toilet cleaners.

Test Procedure

Unscrew the cap of the sample collection tube, then insert the applicator into the stool sample in at least 3 different places, randomly. 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 the extraction solution for 2 minutes. Allow the pouch to reach room temperature before opening. Remove the test device 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 device. Avoid the formation of air bubbles. Start the timer and read the results after 10 minutes. Do not read the results after 20 minutes.

Reading the Results

• Positive: Two colored lines appear, the test line (T) and the control line (C). The intensity of color in the test line (T) region will vary depending on the concentration of H. pylori antigen in the sample. Therefore, any shade of color in the test line (T) region should be considered positive. This result means that H. pylori antigen has been detected in the stool and that you should consult a doctor.
• Negative: Only the control line (C) appears; the test line (T) does not appear. This result means that H. pylori antigen is not detectable in the stool.
• Invalid: The control line (C) does not appear. Insufficient specimen 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 device. If the problem persists, immediately discontinue use of the test kit and contact your local distributor.

Warnings

For in vitro diagnostic self-testing only. Read all information in the package insert before performing the test. Do not eat, drink, or smoke in the area where specimens or kits are handled. If the package is damaged or has been opened, do not use it. Use a clean container to collect the stool sample. Strictly follow the indicated time. Use the test only once. Do not disassemble or touch the test window of the test device. The used test must be disposed of according to local regulations. Keep out of reach of children. The test should be used for the detection of H. pylori antigens in stool specimens only. Do not use the test in the presence of bacteria. Neither the quantitative value nor the rate of increase in the concentration of H. pylori antigens can be determined by this qualitative test. The test will only indicate the presence of H. pylori in the sample and should not be used as the sole diagnostic criterion for H. pylori as a causative agent for peptic or duodenal ulcers. As with all diagnostic tests, all results should be interpreted in conjunction with other clinical information available to the physician. If the 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 infection. 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.

Storage

Store at room temperature or refrigerated (2-30°C). Do not freeze. Shelf life in unopened packaging: 24 months.

Format

The kit contains: test device; sample collection tube with extraction solution; stool collection paper; package leaflet.