One Step H. Pylori Test Device

Product Principle of H.pylori Ab test kit

The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach
ulcers, chronic active gastritis and gastrointestinal adenocarcinoma.
Antibodies to H. pylori are developed in individuals infected with H. pylori as a serological response.
Detecting specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection, either
as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
The H. Pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in
serum/plasma/whole blood specimens.
The test is to be used as an aid in the diagnosis of infection due to H. pylori.

Specimen of H. pylori Ab test Collection and Handling
For whole blood:
Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be
refrigerated at 2-8⁰C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to
room temperature before testing. Using the specimen after long-term storage of more than three days can cause
non-specific reaction. When stored at 2-8 ⁰C, the whole blood sample should be used within three days.
For serum/plasma:
Blood should be collected aseptically into a clean tube without anticoagulants. Separate the serum or plasma from blood
as soon as possible to avoid hemolysis. Use clear non-hemolyzed specimens when possible.

Procedure of H. pylori Ab test kit
> Step 1: When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test
from the pouch.
> Step 2: For Strip Test:
Immerse the strip into the container wtih the arrow end pointing towards the container.
Do not immerse past the MAX(maximum) line.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
For Cassette Test:
Drip 2 or 3 drops of specimen into the sample window.
>Step 3 : Wait 10-15 minutes and read result. Do not read results after 30 15 minutes.

How to read the result of H. pylori test kit
>1. Negative: Only one pink band appears on test region.
>2. Positive: Two pink bands appear on test region.
>3. Invalid: If without colored band appears on test region, this is an indication of a possible error in
performing the test.
The test should be repeated using a new device.

WARNINGS AND PRECAUTIONS FOR Using H. pylori Ab test kit
≡1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
≡2. Use it before expiry date.
≡3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
≡4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.