Detailed Product Description

CE CERTIFICATE

This test is a screening test and all positives must be confirmed using an alternate
test such as western blot. The test is intended for healthcare professional
use only.

Summary:
The rapid H.pyiori test is a simple, visual qualitative test that detects antibodies
in human serum or plasma. The test is based on immunochromatography and can
give a result within 15 minutes.

Principle of the procedure:
The assay starts with a sample applied to the sample well and add provided sample
diluent immediately. The H.pylori antigens-colloidal gold conjugate embedded in
the sample pad reacts with the H.pylori antibody present in serum or plasma sample
forming conjugate/ H.pylori antibody complex. As the mixture is allowed to
migrate along the test strip, the conjugate/ H.pylori antibody complex is captured
by a antibody-binding protein A immobilized on a membrane forming a colored test
band in the test region. A negative sample does not produce a test line due
to the absence of colloidal gold conjugate/ H.pylori antibody complex. The antigens
used in the test are recombinant proteins corresponding to highly immunoreactive
regions of H.pylori. A colored control band in the control region appears
at the end of test procedure regardless of test result. This control band is
the result of colloidal gold conjugate binding to an anti- H.pylori antibody immobilized
on the membrane. The control line indicates that the colloidal gold conjugate
is functional. The absence of the control band indicates that the test
is invalid.

Reagents and materials supplied:
Test cards/ test strips individually foil pouched with a desiccant
Plastic dropper
Sample diluent
Package Insert

Materials required but not provided:
Positive and negative controls

Storage and stability:
The kit must be stored at 2 - 30°C

Warnings and precautions:
1) All positive results must be confirmed by an alternative method
2) Treat all specimens as though potentially infectious. Wear gloves and
protective clothing when handling specimens.
3) Devices used for testing should be autoclaved before disposal
4) Do not use kit materials beyond their expiration dates
5) Do not interchange reagents from different lot of kit

Sample collection and storage:
1) Collect serum or plasma specimens following regular clinical laboratory procedures
2) Storage: a specimen should be refrigerated if not used the same day of collection

Specimens should be frozen if not used within 3 days of collecting. Avoid freezing
and thawing the specimens more than 2-3 times before using. 0.1% of sodium
azide can be added to specimen as preservative without affecting the results
of the assay.