Medical Products Supplies Companies

18 Line of Vasilievsky Island, 3, 199034 St. Petersburg
Russian Federation
Telephone +7 812 3807699
Fax +7 812 3807699
ama@sp.ru
http://www.amamed.eu

Product Categories

Product categories

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.02 Diagnostic rapid tests

Diagnostic rapid tests

Our products

Product category: Diagnostic rapid tests
AMA RUT Expert (INVASIVE DIAGNOSTICS)
The world’s first Rapid Urease Test with Digital Reader

Sensitivity of the device is 98%, specificity – 100%. Such precision is achieved due to several factors:

The result is read by digital optics, which is far more precise than a human eye
The time of analyses is reduced thanks to kinetic evaluation of the test result: the device autostops and saves the result as soon as it becomes available
The structure of AMA RUT Expert stripes allows to reliably determine even the minimum presence of urease in the biopsy sample

Easy to use:

Automatic reading to save doctor’s time
Convenient display
Storage of results in device’s memory

Saves money and biological material:

Multiple biopsy is supported to trace the urease from different parts of the stomach
Same biopsy samples can be sent for further analyses
Kits of 10 and 50 test are available

Easy to store and transport:

Weighs only 40 g
No special conditions needed for transportation
Storage at +15 … +50°С

Product category: Diagnostic rapid tests
HELIC ABT Reader (NON-INVASIVE DIAGNOSTICS)
HELIC ABT Reader – is an innovative automatic testing device for non-invasive diagnostics of Helicobacter pylori (H.pylori) with high accuracy and without the involvement of laboratory.

HELIC Ammonia Breath Test (HELIC ABT) was designed to exclude pain and discomfort during the diagnostic procedure. HELIC ABT is applied by gastroenterologists, general practitioners, staff of primary health centers and allows to implement Near Patient Testings (NPT). No samples need to be sent to a central laboratory.

Advantages

Immediate result- the result is available after 15 minutes of the testing.
Safety – sensitive sorbent of the test allows to detect H. pylori infection without using radioactive isotope markers. It can be also recommended for pregnant women and children.
Painless – non-invasive procedure can be easily applied before and after the therapy course.
Accuracy approved – the test has proved to be highly sensitive (95%) and highly specific (92%).
CE marked – AMA meets the requirements of the In-vitro Diagnostics Directive 98/79/EC and HELIC ABT is CE marked.
Easy to store – shelf-life is 24 months, no special storage conditions are required.

Principle of Operation
During the patient examination two air samples are selected: before and after taking a portion of unlabelled urea 12C. If the patient is infected with Helicobacter pylori, after taking a portion of unlabelled urea 12C, the ammonia in the mouth cavity air will increase and the indicator composition in the tube will change its color from yellow to blue. The device reads and compares the color change and after that it gives the result.

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About Us

Company details
AMA Co Ltd is a leading company in a sphere of developing and manufacturing innovative test-systems for Helicobacter pylori detection.

History

AMA was established by a group of people with experience in the medical and chemical fields.
AMA is focused on developing and producing of innovative test-systems for medical diagnostics and for scientific goals. AMA Co. Ltd since the beginning was actively involved in a field of gastroenterology, producing the test-systems for diagnostics of the stomach infection H.pylori.
Global prevalence of gastritis, ulcer and gastric cancer, which are related to H.pylori, and the urgent need in cheap, express, easy-to-use and precise diagnostics tools were the reasons AMA’s specialists had developed new products: AMA® Rapid Urease Test (AMA® RUT Expert) and HELIC Ammonia Breath Test (HELIC® ABT).

Customers

AMA’s customers are gastroenterologists, pediatricians, therapists, general practitioners, endoscopists.

Certifications and patents

Quality guarantee is AMA’s basic goal. Reliability and safety of AMA® Rapid Urease Test and HELIC® ABT are confirmed by wide clinical trials held in St.-Petersburg, Moscow and other Russian cities. The Health Department of Russian Federation recommended the tests to be extensively applied in medical practice.
AMA’s products have Registration certificates of Health Department of the Russian Federation. The tests are patent protected and have official trademarks internati onally registered.
The quality management system is certificated according to the standarts ISO 9001:2008; ISO 13485:2003.
AMA meets the requirements of the In-vitro Diagnostics Directive 98/79/EC and AMA® RUT and
HELIC ABT® are officially registered in European Community .

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