One Step H.pylori Rapid Test Kit H Pylori One Step H.pylori Rapid Test Kit H Pylori H Pylori Rapid T

INTENDED USE
Hp test kit is an qualitative immunochromatographic assay for the rapid detection of antigens in human stool specimen. The test results are intended to aid in the diagnosis of infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of in peptic ulcer patients.
PRINCIPLE OF THE ASSAY
Hp test kit is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which H. pylori specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If H. pylori antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.
SPECIMEN COLLECTION
Stool specimens should be collected in containers that do not contain media, preservatives, animal serum or detergents as any of these additives may interfere with the HP Stool Ag Test. Specimens may be stored at 2-8°C for 3 days without interfering with the assay performance. For long-term storage of specimens, -20°C or colder is recommended. Repeated freezing and thawing of specimens is not recommended and may cause erroneous results. Do not store specimens in self-defrosting freezers.


ASSAY PROCEDURE
Preparations:

Allow all reagents and samples to equilibrate to room temperature before proceeding with the test.

Write the specimen number on the cassette and sample preparation device.

Procedure:
1.Remove sample probe from preparation device and coat liberally with sample. Replace probe in vial and shake to disperse solid material.
2.For liquid or semi-solid stools, 100µl of stool may be added using an appropriate pipette.
3.Allow the mixture to stand for 1 -2 minutes.
4.Snap top from preparation device and invert. Add 2 – 3 drops (100µl) to the sample well of the test cassette.
5.Leave the test at room temperature and read the results between 5 and 15 minutes after addition of sample. Note: Weak and negative samples may require the full 15 minutes to develop.