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HELIC Ammonia Breath Test (HELIC ABT)
HELIC ABT with indicator tube is designed for primary  noninvasive diagnosis H.pylori infection, as well as for monitoring the status of H.pylori during treatment and for effectiveness checks of therapy which already had been conducted.

Description of the method


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, by staff of primary health centers and dispensaries and allows to implement Near Patient Testings (NPT) in any place and situation. No samples need to be sent to a central laboratory.
This is the biochemical method is based on produces a large amount of urease. H.pylori produces a large amount of urease, which degrades urea to ammonia (NH4+). HELIC ABT uses kinetic registration of ammonia concentration in patient’s breath air before and after a portion of unlabelled urea 12C is taken. The value of ammonia level is expressed in color change of indicator composition inside the tube.




Production


HELIC ABT



Plastic indicator tube with urea load.


Suction pump.
 



Short instruction


Test procedure is very easy. Analysis consists of 2 parts:

Part I. Detection of basal level value.Patient to take the tube into his/her mouth. Aspirate the breath air during the period indicated at  the label on the pump (6 or 7 minutes).

Part II. Detection of load level value after a portion of urea is taken. Ask the patient to take 0,5 g urea dissolved in 50 ml water. After he/she drinks  turn the indicator tube the other side and start the second aspiration.

When test finished compare the basal level value with the load level value. Count the delta by distracting the basal level value from the load level value.If the delta exceeds the 3 mm, the test is positive; the delta is less than the 3 mm, the test is negative.

To view the complete instruction.





Example of color change



Hp-


Hp+




Advantages


Immediate result
The result is available immediately after 15 minutes of the testing.

Safety
Sensitive sorbent of the test allows doctor to detect H.pylori infection without using radioactive isotope markers. It can be also recommended for pregnant women and for children.

Painless
Noninvasive procedure. Can be easily applied before and after the therapy course.

Accuracy approved
The test has proved to be highly sensitive (87%) and highly specific (91%).

CE
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.





Documents


Registration certificate on system for rapid helicobacteriosis diagnostics with breath method

CE Registration certificate 

Certificate ISO 13485:2012 






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