AMA RUT EXPERT
precise diagnostic of Helicobacter pylori
for everyday use
Helicobacter pylori
is a bacterium that may cause such diseases as gastritis, stomach or duodenal ulcer, and stomach cancer
precise diagnostics in the course
of gastroscopy. Multiple biopsies
from different areas of the
stomach is recommended by Sydney protocol because it increases accuracy, as confirmed by the studies.
Why is AMA RUT Expert precise?
convenient when taking many biopsy specimens
up to three specimens
AMA RUT Expert. The competent possibility for multiple biopsies.
redesignedformat
enlarged effective area in AMA RUT Expert allows evaluating the results of up to 3 biopsy specimens.
AMA RUT Expert
precise with
AMA RUT Expert. The largest sensitive element among the non-buffer RUTs.
Conventional RUT
the effective area of the cassette is only about 3%
precise, selective, multilayer
sensitive layer
indicator layer
advanced structure with the sensitive layer, comprising a special membrane
The indicator layer is separated from substances that cause non-target reactions. The test is selective, showing positive results only in the presence of H.pylori urease.
The design of AMA RUT Expert is patent protected in Russia and worldwide; "AMA" and "AMA RUT" are registered trademarks of AMA Co Ltd
precise because readable
The results of AMA RUT Expert tests can be easily assessed visually but the tests-slides are also digitally readable. The optional photometric-based AMA RUT Reader helps the testing by:
-
eliminating human factor errors in reading the test results
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providing semi-quantitative results that correlate with histologically assessed levels of inflammation and atrophy*
-
clearly positive-negative results without a grey zone
The innovative high tech AMA RUT Reader processes multiple checks and beeps as soon as the result becomes available.
AMA RUT Expert with Reader. Great in Optics – Small in Size. Unique focus on healthcare and technology.
XXXIVth International Workshop on Helicobacter & Microbiota in Inflammation and Cancer. September 8-10, 2021
Test device, reactive element and arrangement for urease activity are patent protected (European Patent Office EP3009519B1)
precise: confirmed by the studies
“To achieve the most accurate diagnostics of H.pylori in patients with dyspeptic symptoms it is recommended to use the photometry of enzymatic reaction regularly”
The sensitivity, specificity and accuracy of AMA RUT Expert are 98, 100, and 99%, respectively. *Manufacturer’s validation data (n=200) are confirmed by independent study (n=585):
Research by the Saint-Petersburg Pasteur Institute verified the absence of reaction towards other urease producers and confirmed compliance of the semi-quantitative assessment with the Reader to the degree of bacterial contamination.**
*Federal State Budgetary Institution "Federal Scientific and Clinical Center for Specialized Types of Medical Aid and Medical Technologies of the Federal Medical and Biological Agency", Clinical Product Evaluation Protocol, Russia, 2019.
**Saint-Petersburg Pasteur Institute of Epidemiology and Microbiology, St. Petersburg, Russia. Study Protocol No. 6/2, 2017.
test for everyday use: no buffer, no suffering
place the sample
read the result
The AMA RUT Expert dry rapid urease test with the multilayer structure does not require additional buffer liquids. The operator has fewer actions to take.
Old-school buffer-based urease tests suffer from reduced sensitivity and increased incubation time. The buffer, being intended to consume acid or base on the specimen inevitably inhibits pH changes thus decreasing the indicator reaction, especially in weakly positive specimens.
The testing with AMA RUT Expert is quick and precise.
simple procedure
AMA RUT EXPERT
1
Separate one test-slide along the perforation lines.
2
Open the protective cover, but do not pull hard not to tear it off.
3
Place one, two or three biopsy specimen(s) on the white reactive element, and not beyond.
4
After the last biopsy is placed, reseal the cover. Gently smooth the cover with your finger around the perimeter of the test-slide.
5
Insert the slide into the slot of AMA RUT Reader and push the button until the display shows "RUN". The reader will continue automatically and the results will be saved.
6
If you use AMA RUT Expert for a visual evaluation, check the results from the back of the test after 14 minutes.
Please read all the instructions for use prior to performing the test.
test for everyday use: readable
use the optional AMA RUT Reader to speed up the testing procedure
Reduced time of analysis is achieved thanks to the kinetic evaluation of the test result: the device stops automatically and saves results as soon as they are available. While visual reading requires checking for the results after 14 minutes, the Reader provides that most of the positive results are available after just 5 minutes.
test for everyday use: the block format
The slim tests are compact and easy to store.
The envelope package makes it convenient to transport.
test for everyday use: automated ISO-certified production
Production processes of AMA RUT Expert involve an increased degree of automation. The innovative equipment is a key to the mass assembly of the tests and short order lead times.
All the manufacturing processes are validated in accordance with the GHTF recommendations and comply with the requirements of international standards ISO 9001:2015 and ISO 13485:2016.
test for everyday use:
test for everyday use:
environment matters
AMA RUT Expert is cassetteless —
environment matters
It means less weight and less
plastic compared to conventional RUTs.
With a mass of 0,6g only, AMA RUT Expert test slide is 6 times lighter than a conventional RUT.
step by step
how to use the test
AMA RUT Expert is trusted by doctors around the world.
AMA-Med Oy
