AMA RUT Pro
H.pylori Rapid Urease Test in the course of gastroscopy
testing with AMA RUT Pro is so fast that reporting can be done at the same appointment, after the biopsy is taken
rapid 5-minute testing
AMA RUT Pro: dry and fast
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.
Compared to the gel-based, dry urease tests allow for a higher response time, study confirm.
AMA RUT Pro is a dry rapid urease test with the multilayer structure, designed for the fast reaction.
the reactions run faster thanks to the patented design of the test
II
I
I sensitive layer: the enzymatic reaction with H. pylori urease and urea
leads to the formation of ammonia (the first reaction)
only the ammonia from the first reaction penetrates to the next layer
II indicator layer: ammonia raises the pH (second reaction) resulting in the target color change
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 10 CFU Helicobacter pylori.
4
WO2020139142 patent pending. The design of AMA RUT Pro is patent protected in Russia and internationally; "AMA" and "AMA RUT" are registered trademarks of AMA Co Ltd
multilayer structure to ensure the target reaction only
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.
In tests without effective multilayer structure non-target reactions may occur due to:
• 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)
AMA RUT Pro enjoys advantages of multilayer structure to ensure specific detection of H. pylori urease.
innovative arrangement of the multilayer structure
sensitive layer
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
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.
AMA RUT Pro is protected from the risks of false staining.
high accuracy: specificity 99% sensitivity 99%
No reaction towards interfering substances (alkaline agents, blood) or non-target bacteria.
After the test is done, the biopsy specimen is still applicable for further histology, PCR or culture detections, when required by guidelines.
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
how to use the test
Test procedure
1
Bend the block along the
perforation lines.
2
Separate one segment for
examination.
3
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.
4
After placing the biopsy, gently smooth the protective cover with your finger around the perimeter of the test.
5
Fix the cover along the cut line.
Fixation is necessary to preserve
the reaction products in the
express test cell.
6
Check the result from the
back of the test after 5 minutes.
Please read all the instructions for use prior to performing the test.
Manufacturing certified according to the international QMS
Since 2011, the Association of Medicine and Analytics LLC has been the first in Russia integrated quality management system that meets the requirements of GOST R ISO 9001 (ISO 9001) and GOST R ISO 13485 (EN ISO13485).
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.
Contact card
AMA-Med Oy
AMA Co Ltd
