| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Transport Package: | Carton |
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Helicobacter Pylori Antigen Test Kit (Immunochromatography)
Instructions For Use
For professional use only
For in vitro diagnostic use only
Please read these instructions carefully before use!
[INTENDED USE]
The Helicobacter Pylori Antigen Test Kit (Immunochromatography) is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigen in human feces. It is intended as an aid in the diagnosis of Helicobacter pylori infection.
[INTRODUCTION]
Helicobacter pylori (Hp) is a gram-negative, aerobic bacterium that colonizes the stomach and duodenum. Hp infection is widespread, affecting over 50% of the global population, primarily through oral transmission. This infectious disease can lead to chronic gastritis and peptic ulcers, with symptoms including upper abdominal discomfort, bloating, anorexia, nausea, vomiting, and dark or tarry stools; however, about 70% of infected individuals are asymptomatic. Hp is a major cause of gastritis and peptic ulcers and is closely associated with functional dyspepsia, MALT lymphoma, and gastric cancer. The WHO International Agency for Research on Cancer (IARC) classifies Hp as a Group I carcinogen. Eradicating Hp can significantly reduce the risk of gastric and duodenal diseases, including gastric cancer, and help prevent new infections. While bacterial culture is the standard detection method, it requires demanding conditions and expertise, limiting its widespread use. In contrast, this immunochromatographic test kit requires no expensive equipment, is easy to operate and interpret, and offers good sensitivity and specificity, making it increasingly popular.
[PRINCIPLE]
The test employs a double-antibody sandwich method to detect Hp antigen in human feces. Anti-Hp antibodies are immobilized in the test line (T) region. When a processed stool specimen contains Hp antigen, it binds to the antibodies, forming a red test line. The absence of this line suggests a negative result. A red control line (C) will always appear if the test procedure is performed correctly, indicating valid specimen volume and chromatographic flow.
[MATERIALS PROVIDED]
Test Cassette
Sample collection tube with extraction buffer
Instructions for use
[MATERIALS REQUIRED BUT NOT PROVIDED]
Timer
Disposable specimen container
[STORAGE AND STABILITY]
Store the sealed pouch at 4°C to 30°C.
The kit is stable for 24 months from the production date, as indicated on the pouch.
Keep the test device in the sealed pouch until ready for use.
Use the test within 60 minutes after opening the pouch.
Do not freeze.
Do not use beyond the expiration date.
[SPECIMEN COLLECTION AND STORAGE]
Specimen Collection:
Remove the cap and applicator stick from the collection tube.
Poke the stick into the feces sample at different sites approximately 6 times (collecting about 8-20mg).
Reinsert the stick into the tube, tighten the cap, and shake well.
Note: Handle all specimens as potentially infectious. Collect fresh feces, avoiding contamination with urine, disinfectants, or water.
Specimen Storage:
Collect fresh feces in a clean, dry container.
Test immediately after collection. If testing is delayed, specimens can be stored at 2-8°C for up to 24 hours. For long-term storage, keep at -20°C or below.
Bring refrigerated or frozen specimens to room temperature before testing. Mix thawed specimens thoroughly.
Avoid repeated freeze-thaw cycles. Testing immediately after collection is recommended for optimal results.
[TEST PROCEDURE]
Shake the sample collection tube containing the specimen thoroughly.
Open the foil pouch and place the test cassette on a flat, dry surface.
Remove the cap from the collection tube and dispense 3 drops (approximately 100μL) of the liquid into the sample well.
Read the results at 15 minutes. Do not interpret results after 20 minutes.
[INTERPRETATION OF RESULTS]
[LIMITATIONS]
This test is an aid for early detection of Hp infection but is qualitative and does not indicate antigen concentration levels.
Results are for reference only and should not be the sole basis for clinical diagnosis. Physicians must consider symptoms, signs, medical history, other lab tests, and treatment response.
A negative result does not completely rule out Hp infection, as antigen levels may be below the test's detection limit.
[PERFORMANCE CHARACTERISTICS]
Limit of Detection: The detection limit is 3×104 CFU/mL.
Cross-Reactivity: Testing with potentially cross-reactive organisms at high concentrations (1×107 CFU/mL) showed no significant cross-reactivity.
Interfering Substances: The following potentially interfering substances, when added to negative and positive specimens, did not affect the test results.
(Table for interfering substances would be listed here)
[WARNINGS AND PRECAUTIONS]
For in vitro diagnostic use only.
For professional use only.
Do not use if the protective pouch is damaged or already open.
Do not touch the membrane in the result window.
Use the test device immediately after opening the pouch; prolonged exposure to air may cause deterioration.
Use the specified number of sample drops. Too many or too few can lead to inaccurate results.
Do not mix components from different lots.
Read results in adequate light to ensure accurate visual interpretation.
Treat all samples and used devices as potentially infectious. Avoid skin contact.
Use only within the stated validity period.
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