The test-system consists of a single use test AMA RUT Expert (hereinafter referred to as slide) and the AMA RUT Reader. The intended use is specific rapid H.pylori detection by establishing the presence of urease activity in a biopsy specimen taken from either adult or child patients during the gastroscopy procedure.
Helicobacter pylori AMA Rapid Urease Test Expert
The principle of operation is based on the colour change of the indicator after the biopsy specimen(s) placed on the reactive element of the slide. In the event of urease activity in the biopsy specimen(s), a red or magenta spot appears on the slide. The Reader takes multiple readings to check if the spot appeared. The higher the urease activity is, the faster the detection time. The Reader stops as soon as it detects a spot or proceeds up to the maximum exposure time (14 minutes) to confirm the absence of the spot and thus the negative result of the test. The result is indicated on the display and saved.