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SIENTIFIC DEVELOPMENS / Breathe Test Instruments and Methods for reliable...
Breathe Test Instruments and Methods for reliable,
accurate and rapid Helicobacteriosis diagnostic.
Background and present
Helicobacter pylori (H. pylori) are the spiral-shaped bacterium’s that are found in the gastric mucous layer or adherent to the epithelial lining of the stomach.
It is now accepted that infection of the gastric mucosa with H. pylori causes chronic gastritis. Virtually everyone infected with H. pylori develops life-long chronic gastritis, but only a minority of infected individuals will develop a clinically relevant disease, such as peptic ulcer or gastric carcinoma. H. pylori cause more than 90% of duodenal ulcers and up to 80% of gastric ulcers. More than 90% of peptic ulcer patients are infected with H. pylori and it has been shown that successful treatment prevents ulcer relapse. National and international guidelines have been published on the management of H. pylori, and it is tacitly assumed that these guidelines are adhered to in clinical practice. Patients commonly visit both primary care physicians and gastroenterologists because of upper gastrointestinal symptoms.
The abundance of H. pylori causes a necessity of using in clinic practice express, precise and affordable diagnostic tests. The detection of H. pylori specified urea activity is on the basis of developed by Scientific Technical Company "TKA" the urea breath test "HelicoSense". Breath Test Gas Analyzers "HelicoSense" produce in three modifications – "Routine", "Scientific" and "Mobile". All of them are medical-purpose measuring devices. The constructions and programs of "HelicoSense" are patented (RU Pat. #30545, 2003611301, 2006613342, 2006613595).
The type tests are carried out in All-Russia D.I. Mendeleyev Scientific and Research Institute for Metrology (State Scientific Centre of the Russian Federation/State Test and Measurement Instrument Certification Centre) successfully.
During clinical tests, carried out in Saint Petersburg State Pediatric Academy, I.I. Mechnikov Saint Petersburg State Medical Academy and Peoples’ Friendship University of Russia (Moscow), revealed - high specificity (86%) and high sensitivity (95%) for children. For adult - 85.5%, 94% correspond to specificity and sensitivity.
Based on successful results of the clinical tests the Registration Certificate # FS 022а2006/4380-06 from Federal department on surveillance in healthcare and social development sector was receipted.
It is known that the helicobacteriosis of any localization associate with ammonia in the air, expired by a patient. Diagnostics is carried out by measuring the concentration of ammonia in the air, expired by a patient after he takes Diagnosticum. Calculation of basal concentration of ammonia allows taking into consideration patient’s individual peculiarities and increase the accuracy of the test.
Electrochemical sensor, which gives on exit an electrical signal, proportional to concentration of ammonia, serves as a measuring converter. The sensor has a high resolution - 0,025 mg/cub m. High selectivity of the sensor allows excluding the influence of other expired gases on the results of the test.
The result of patients test is Infection Index (I.I.). By dynamics of I.I. changes primary care physicians/gastroenterologist/pediatricians can define the efficiency of eradication therapy type.
Its note, what "HelicoSense" are expedient for medical-purpose by express diagnostics in primary care physician’s offices, gastroenterological children’s and adult stationers, hospitals, screening tests for epidemic researches, private practice doctors and to monitor eradication courses.
The results of "HelicoSense" clinic practice use are:
- Non-traumatic medical technique;
- Increase accuracy and automatization of tests procedure;
- Tests procedure simplification;
- Decrease of test time to 2-10 minutes – the test duration determine by "HelicoSense" automatically;
- Decrease of carrying expenses.
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