AMA RUT CLO H Pylori Test

AMA RUT CLO  Test - H Pylori in gastric biopsy

This test is a rapid rapid detection of Helicobacter pylori presence in gastric bioptic specimens.

Intended Use and Principle of Operation
The device is intended for specific rapid Helicobacter pylori detection by establishing the presence of urease activity in a biopsy specimen. The test is administered by endoscopy surgeons during the gastroscopy with a biopsy taken from either adult or child patients.
The principle of operation is based on the color change of the indicator disk after the biopsy specimen has been placed on its surface of the indicator disk.
The biomaterial tested could be:
- a biopsy specimen taken from any part of the stomach.
- a biopsy specimen taken from the duodental cap.
The size of the biopsy specimen should be no less than 2mm (at any dimension).
Design of the device
The device is a rectangular-shaped polymer carrying base with a transparent hole in which the indicator disk is imbedded and hermetically sealed by a transparent protective cover.