Diagnostic H. Pylori Antigen Detection Rapid Test Kits
NTENDED USE
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 adenocar cinoma. 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 specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.
PRINCIPLE OF THE TEST
H. Pylori Rapid Test is a lateral flow, immunochromatographic screening test.  H. pylori specific antigens are precoated onto membrane as a capture reagent on the test band region.  During the assay the Whole Blood specimen is first allowed to react with H. pylori specific antigen-gold conjugate complexes.  The mixture then moves laterally on the membrane to the test region which is coated with immobilized antibodies to H. pylori.  If H. pylori antibodies are present in the specimen, a color band is formed on the test (T) region.  Absence of the colored band in the test region indicates a negative result.  To serve as a procedural control, a colored band in the control (C) region will always appear regardless the presence of H. pylori antibodies in the whole blood specimen.
REAGENTS AND MATERIALS SUPPLIED
FOR TEST DEVICE 
1. Test devices individually foil pouched with a desiccant.
2. Plastic dropper.
3. Package insert
4. Buffer
MATERIALS REQUIRED BUT NOT PROVIDED
1. Whole Blood collection containers
2. Clock or Timer
WARINGS AND PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not use the kit beyond the expiration date imprinted on the outside of the foil pouch.
3. Do not open foil pouch until specimen is collected and ready to be tested.
4. Handle all specimens as potentially infectious.
STORAGE AND STABILIRY
The test device can be stored under refrigeration and room temperature (2-30^oC) and will be stable until the expiration date. Do not use after the expiration date
SAMPLE COLLECTION
The HP Rapid Test Device (Whole Blood) can be performed using whole blood.
Both Fingerstick Whole Blood and Venipuncture Whole Blood can be used
To collect Fingerstick Whole Blood specimens:
Wash the patient's hand with soap and warm water or clean with an alcohol swab.  Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet.  Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing.
If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
BEFORE TESTING

1. Bring all materials and specimens to room temperature.
2. Remove test device from the sealed foil pouch.  

ASSAY PROCEDURES
1. Bring all materials and specimens to room temperature.
2. Remove test device from the sealed foil pouch.
3. Place the test device on a flat dry surface.
4. Using the provided plastic dropper, dispense a drop of whole blood (about 30μl of sample) to the sample pad of Strip or Sample well(S) of the test card, then add 2 full drops of buffer (approximately 60 uL). Start timing.
5. Read result between 5 to 10 minutes after adding the sample.

READING THE RESULT
Negative: Only one colored band appears on the control region. No apparent band on the test region .It indicates absence of antibodies to H. pylori in the specimen.
Positive: In addition to a pink colored control band, a distinct pink colored band will also appear in the test region. This indicates that indicates presence of antibodies to H. pylori in specimen.
Invalid: A total absence of color band in both (T) and (C) regions or no colored band appears on the control (C) region is an indication of procedure error and/or that the test reagent has deteriorated. Repeat with a new test kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.