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HP Ag Test (Colloidal Gold)

Overview

The kit is a lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in the human fecal specimens. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with H. pylori. Any reactive specimen with the H. pylori Ag Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Summary

H. pylori is a type of bacteria. These germs can enter the body and live in the digestive tract. After many years, they can cause sores, called ulcers, in the lining of the stomach or the upper part of the small intestine. For some people, an infection can lead to stomach cancer.

Infection with H. pylori is common. About two-thirds of the world’s population has it in their bodies. For most people, it doesn’t cause ulcers or any other symptoms. If people do have problems, there are medicines that can kill the germs and help sores heal.

People can get H. pylori from food, water, or utensils. It’s more common in countries or communities that lack clean water or good sewage systems. People can also pick up the bacteria through contact with the saliva or other body fluids of infected people.

Many people get H. pylori during childhood, but adults can get it, too. The germs live in the body for years before symptoms start, but most people who have it will never get ulcers.

Contents Include

  • 20/25 test cassettes: each sealed foil pouch containing one test device and one desiccant

  • 20/25 feces collection device: Each device contains 1mL extraction buffer

Storage and Stability

  • Store at 4°C~ 30°C(39.2°F~86°F)in a dry place and avoid direct sunlight. Do not freeze. The expiry date is 18 months.

Specimen Collection and Handling

  • Consider any materials of human origin as infectious and handle them using standard bio-safety procedures.

  1. Collect a random feces specimen in a clean, dry receptacle.

  2. Open the feces collection device by unscrewing the top and use the collection shovel to randomly pierce the feces specimen in 2~5 different sites to collect around 100mg solid feces (equivalent to 1/2 of a pea) or 100μL liquid feces. Do not scoop feces specimens as this may lead to an invalid test result.

  3. Ensure feces specimen is only in the grooves of the collection shovel. Excess feces specimen may lead to an invalid test result.

  4. Screw on and tighten the cap onto the specimen collection device.

  5. Shake the feces collection device vigorously.

Test Procedure

  1. Bring the specimen and test components to room temperature if refrigerated or frozen.

  2. When you are ready to begin testing, open the sealed pouch by tearing it along the notch. Remove the test from the pouch.

  3. Place the test device on a clean, flat surface.

  4. Position the feces collection device upright and twist off the dispenser cap.

  5. Holding the feces collection device vertically, dispense 2 to 3 drops (around 80μL) of the solution into the specimen well of the test device. Do not overload specimens.

  6. Read the test result within 15 minutes. Do not read the result after 15 minutes.

Do not read the result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.

Results Interpretation

  1. Positive: Two red-purple lines appearing at both test line (T) and control line (C) indicate a positive result.

  2. Negative: Only one red-purple line appearing at the control line (C) indicates a negative result.

  3. Invalid: No red-purple line at the control line (C) indicates an incorrect assay process or failure of the kit. Read this instruction carefully and repeat the test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.

Limitations

  1. The kit is for in vitro diagnostic use only.

  2. The kit is limited to the qualitative detection of H. pylori antigen in human fecal specimens. The intensity of the test line does not have a linear correlation with the antigen titer in the specimen.

  3. A negative result for an individual subject indicates the absence of detectable H. pylori antigen. However, a negative test result does not preclude the possibility of infection with H. pylori.

  4. A negative result can occur if the concentration of the H. pylori antigen present in the specimen is below the detection limits of the assay or if the antigens that are detected are not present in the fecal specimen collected.

  5. If symptoms persist and the result from the test is negative or non-reactive, it is recommended to re-test the patient a few days later or test with alternative test methods.

  6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

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