CE certificate IVD Infections diseases H.Pylori Antibody diagnostic rapid test strip H.Pylori Antibody rapid test kit 

Intended Use of H. pylori Antibody Rapid Test Device

The H. pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgM and IgG antibodies to Helicobacter pylori in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.

Principle of H. pylori Antibody Rapid Test Device

The H. pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies specific to Helicobacter pylori through visual interpretation of color development on the internal strip. H. pylori antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with H. pylori antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to Helicobacter pylori in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Procedure and Result Reading of H. pylori Antibody Rapid Test Device

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.

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