INTENDED USE
The H. pylori Antigen Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
| Storage |
2~30 º C |
| Specimen |
Feces (Stool) |
| Component |
Rapid Test + Extraction Tube with Buffer |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 5mins |
| Package |
25tests/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The H. pylori Antigen Rapid Test (Feces) has been designed to detect Helicobacter pylori through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-H. pylori monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored anti-H. pylori monoclonal antibody colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough H. pylori antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
• Rapid test cassette with desiccant.
• Specimen dilution tubes with buffer
• Package insert
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
SAMPLE COLLECTION
1) The FOB Rapid Test is intended for use with human fecal specimens only.
2) Patients should not collect samples during or within 3 days of their menstrual period if they have bleeding hemorrhoids, blood in the urine, or if they experienced strain during their bowel movement.
3) Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation resulting in occult bleeding. Such substances should be discontinued at least 48 hours prior to testing.
4) No dietary restrictions are necessary before testing.
5) Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
6) Bring specimens to room temperature prior to testing.If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
Use the specimen collection cards provided in the kit for specimen collection. Follow the instructions on the specimen collection card. Other clean, dry containers may also be used for specimen collection. For best results, performed the test within 6 hours after collection.
Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces.
Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
Shake the specimen collection tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
2. Testing
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
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