AMA RUT Pro
H. pylori Rapid Urease Test in the course of gastroscopy
rapid 5-minute testing
testing with AMA RUT Pro
is so fast that reporting can
be done at the same
appointment, after the
biopsy is taken
is so fast that reporting can
be done at the same
appointment, after the
biopsy is taken
AMA RUT Pro: dry and fast
Compared to the gel-based, dry urease tests allow for a higher response time, study confirms.
Traditional liquid and gel-based urease tests use a few hundred
microliters of medium and ammonia produced slowly by weakly
positive specimens. A larger amount of ammonia must be
produced to give a color change. Thus, the incubation time required
for a color change increases disproportionately as the urease
content of the specimen decreases. In addition, the buffer that is
included in the test medium to consume acid or base on the
specimen inhibits pH changes due to production of ammonia. This
reduces assay sensitivity and increases incubation times.
microliters of medium and ammonia produced slowly by weakly
positive specimens. A larger amount of ammonia must be
produced to give a color change. Thus, the incubation time required
for a color change increases disproportionately as the urease
content of the specimen decreases. In addition, the buffer that is
included in the test medium to consume acid or base on the
specimen inhibits pH changes due to production of ammonia. This
reduces assay sensitivity and increases incubation times.
AMA RUT Pro is a dry rapid urease test
with the multilayer structure, designed
for the fast reaction.
with the multilayer structure, designed
for the fast reaction.
the reactions run faster thanks to the patented design of the test
only the ammonia from the first reaction penetrates to the next layer
WO2020139142 patent pending. The design of AMA RUT Pro is patent protected internationally;
"AMA" and "AMA RUT" are registered trademarks of AMA Co Ltd
"AMA" and "AMA RUT" are registered trademarks of AMA Co Ltd
If the biopsy sample is H. pylori positive, the two reactions go consequently in the
different layers of the test, resulting in a bright color change within just 5 minutes.
The sensitivity threshold is 104 CFU Helicobacter pylori.
different layers of the test, resulting in a bright color change within just 5 minutes.
The sensitivity threshold is 104 CFU Helicobacter pylori.
II
indicator layer: ammonia raises the pH (second reaction) resulting in the target color change
II
I
sensitive layer: the enzymatic reaction with H. pylori urease and urea
leads to the formation of ammonia (the first reaction)
leads to the formation of ammonia (the first reaction)
I
multilayer structure to ensure the target reaction only
• throwing bile, the pH of which can be> 7.0, into the stomach
• instability of the reagent in liquid urease tests over time or chemical reactions caused by autolysis of gastric tissue cells
• blood contamination of biopsy (normal blood pH is > 7.3)
• instability of the reagent in liquid urease tests over time or chemical reactions caused by autolysis of gastric tissue cells
• blood contamination of biopsy (normal blood pH is > 7.3)
In tests without effective multilayer structure
non-target reactions may occur due to:
non-target reactions may occur due to:
The non-target reactions appear when the color
of the test changes due to pH shift regardless
the presence or absence of H. pylori urease.
of the test changes due to pH shift regardless
the presence or absence of H. pylori urease.
AMA RUT Pro enjoys advantages of multilayer structure
to ensure specific detection of H. pylori urease.
to ensure specific detection of H. pylori urease.
innovative arrangement of the multilayer structure
The biopsy sample is first reacted with a urea
substrate under pH-optimized conditions on one side of the sensitive layer. Ammonia resulting from the reaction, penetrates to the other side of the membrane, where it comes into contact with an optimized indicator layer to obtain a bright color change.
substrate under pH-optimized conditions on one side of the sensitive layer. Ammonia resulting from the reaction, penetrates to the other side of the membrane, where it comes into contact with an optimized indicator layer to obtain a bright color change.
The sensitive layer of AMA RUT Pro comprises a special membrane. It separates the indicator layer from substances that can cause non-target reactions in the biopsy.
←
indicator
layer
layer
←
sensitive
layer
layer
AMA RUT Pro is protected from the risks of false staining.
high accuracy: specificity 99% sensitivity 99%
After the test is done, the biopsy specimen is still applicable for further histology, PCR or culture detections, when required by guidelines.
No reaction towards interfering substances (alkaline agents, blood) or non-target bacteria.
quick and clear result
* actual photos of AMA RUT Pro reactions
Evident color change: no “halo-effect” or “glow-effect”, results are easy to interpret
cassette-less design helps reduce the amount of plastic
We care about the environment. Since medical grade plastic is not recyclable, it is important to reduce its use.
an average cassette test utilizes 9 times more plastic
the weight of one AMA RUT Pro test-slide is 0.4 grams only
combined in blocks, AMA RUT Pro minimizes package size and weight
The block contains 24 pieces of AMA RUT Pro tests. Before the test, one test-slide is separated from the block.
AMA RUT Pro reduces costs thanks to its block design.
packed in light envelopes to minimize transport cost
1 box = 50 envelopes (1200 or 2400 tests)
Boxes keep costs for international logistics low
Boxes keep costs for international logistics low
1 envelope = 1 or 2 blocks of AMA RUT Pro (24 or 48 tests)
Envelopes are very convenient for local deliveries to clinics
Envelopes are very convenient for local deliveries to clinics
24 AMA RUT Pro = 1 block
how to use the test
Test procedure
Open the protective cover, but do not pull hard not to tear it off,
place the biopsy specimen
on the white reactive element,
and not beyond.
place the biopsy specimen
on the white reactive element,
and not beyond.
Separate one segment for
examination.
examination.
Bend the block along the
perforation lines.
perforation lines.
Check the result from the
back of the test after 5 minutes.
back of the test after 5 minutes.
Fix the cover along the cut line.
Fixation is necessary to preserve
the reaction products in the
express test cell.
Fixation is necessary to preserve
the reaction products in the
express test cell.
After placing the biopsy, gently smooth the protective cover with your finger around the perimeter of the test.
Please familiarize yourself with the Test procedure prior to performing the test.
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Manufacturing certified according to the international QMS
Registration and certification. The quality management system is certified according to the ISO 13485:2016 standard.
All production processes are validated in accordance with the GHTF (Global Harmonization Task Force) guidelines. A comprehensive system of internal control of the main and auxiliary production processes of test systems and equipment has been developed and implemented.
All production processes are validated in accordance with the GHTF (Global Harmonization Task Force) guidelines. A comprehensive system of internal control of the main and auxiliary production processes of test systems and equipment has been developed and implemented.
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(c) 2016-2026
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