Disposable Helicobacter Pylori Rapid Test Convenient Detection H Pylori Antigen Test Kit

Rapid And Convenient Detection Of Helicobacter Pylori

     The H. Pylori Ag Rapid Test Device (Feces) is a rapid chromatographic immunoassay for the qualitative detection of antigens to H. Pylori in feces to aid in the diagnosis of H. Pylori infection.

Detection Principle

      The H. Pylori Ag Rapid Test Device (Feces) is a non‐invasive lateral flow assay, rapid, precise and easy to perform.This test makes use of specific antibodies against H. Pylori antigen adsorbed onto a reactive membrane. If H. Pylori is present in stool specimen, the specific antigen is bound by the second antibody which is conjugated with colloidal gold particles. A generic antibody, fixed onto the reactive membrane, in shape of the band, is able to capture the second conjugated antibody, assuring the correctness of the test performance.

SPECIMEN COLLECTION AND STORAGE

• Patients should not collect samples during their menstrual period, if they have bleeding hemorrhoids, blood in the urine, or if they have strained during bowel movement.
• Collect a random sample of feces in a clean dry container or receptacle.
• Unscrew and remove the collection tube applicator stick. Be careful not to spill or spatter solution from container.
• Collect random sample by using the applicator stick. Take sample from various surfaces of the feces specimen from 3 points.
• Re‐insert the applicator stick into the tube and screw the cap tightly. Be careful not to break the tip of the Sample Collection Tube.
• The diluted sample must be tested in 30 minutes, otherwise the results would be not correct.

PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15‐30°C) before use.

1. Specimen collection and pre‐treatment:

1) 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.

2) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

3) Shake the specimen collection tube vigorously to mix the specimen and the 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

1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.

2) Using a piece of tissue paper, remove the tip of the dilution tube. Hold the tube vertically and dispense 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 drop any solution in observation window. As the test begins to work, you will see color move across the membrane.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2.  Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

LIMITATIONS OF THE TEST

1. . The H. Pylori Ag Rapid Test Device (Feces) is for in vitro diagnostic use only. The test should be used for the detection of H. Pylori antigens in feces only. Neither the quantitative value nor the rate of increase in H. Pylori antigen concentration can be determined by this qualitative test.
2. The H. Pylori Ag Rapid Test Device (Feces) will only indicate the presence of H. Pylori antigens in the specimen and should not be used as the sole criteria for the diagnosis of H. Pylori infection.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of H. Pylori infection.

Preservation and stability of products

• The kit should be stored at 2‐30°C until the expiry date printed on the sealed pouch. 
• The test must remain in the sealed pouch until use. 
• Do not freeze. 
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

KIT COMPONENTS

• Individually packed test devices           Each device contains a strip with colored conjugates and reactive reagents pre‐spreaded at the corresponding regions
• Tubes with buffer           Phosphate buffered saline and preservative, extract the samples
• Package insert           For operation instruction

MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection container     For specimens collection use
• Timer     For timing use
• Centrifuge     For preparation of clear specimens