Description
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.
