Helikit ®
Helikit ® Product Description
Helicobacter pylori (H.pylori) is a bacterium that infects a large proportion of the population. Most individuals infected with H.pylori develop chronic gastritis, which may progress into a duodenal or gastric ulcer. Many ulcer patients develop gastric cancer. Fully 20% to 40% of the North American population and up to 70% of the South East Asian population are reported to be infected with this bacterium. H.pylori eradication may be obtained using antibiotic therapy.
However, without proper diagnosis and confirmation of eradication, proper management cannot be achieved. Isodiagnostika has developed a novel, non-invasive, non-radioactive and convenient breath test kit for the diagnosis of H.pylori called Helikit®.
This simple test incorporates Isodiagnostika's process and 13C formulation. The test method is very convenient. The patient exhales a normal breath sample into the reference labeled tube. The 13C substrate is then consumed. After 30 minutes, the patient then exhales a second breath sample into the second sample tube. The two tubes are then analyzed by an isotope ratio mass spectrometer (IRMS).
Helikit® is also available in a version for analysis with an infrared point-of-care instrument. Please note that patients are required to fast four hours prior to taking Helikit®. Helikit® is practical and features 98% sensitivity and 95% specificity, for an overall diagnostic accuracy of 96%.
Since Helikit® is non-radioactive, it is safe to be used on children over the age of 6 and during pregnancy. It is simple to perform and can be readily used in the physicians' offices in a point-of-care environment with a non dispersive infrared spectrometer (NDIRS) or in medical laboratories with an IRMS.
Although a number of diagnostic products are available for the diagnosis of H.pylori, Helikit® is the only test that is non-invasive, non-radioactive, safe and requires only the patients' breath samples. Helikit® is also the only test available in formats for use on either an IRMS or NDIRS. This unique test is a research product of Isodiagnostika, the leader in breath test analysis and a company specializing in the use of non-radioactive isotopes.