Ama Rut Expert Manual De Instrucciones página 4

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Thank you for choosing AMA RUT Expert, the rapid urease test for semi-quantitative detection of
H.pylori. Please follow the instructions carefully, and the test-system will help to diagnose your
patients better and save your time.
I
NTENDED USE AND PRINCIPLE OF OPERATION
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.
Biomaterial test samples could be:

a biopsy specimen taken from any part of the stomach;

a biopsy specimen taken from the duodenal cap.
One to three specimens can be tested at the same time. The size of a biopsy specimen should be no
less than 2 mm at any dimension.
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.