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PYtest® is approved by the US-FDA and the Australian TGA as a safe and non-invasive 14C Urea Breath Test to be used in the detection of Helicobacter pylori, the bacterium known to cause gastric and duodenal ulcers.
The PYtest® is very quick and is simple to use, only taking 10 minutes to complete due to its "cutting edge" design which uses "micro beads" to get to the Helicobacter pylori infection site in the mucous layer.
The PYtest® kit is a self contained diagnostic test which involves swallowing a gelatine capsule with a small cup of water then, after 3 minutes, drinking a second small cup of water, then waiting 7 minutes before blowing into a special breath collection balloon.
The breath sample collected using the unique balloon system is then analysed. The balloon with the patient's breath sample contained within it is designed to withstand different air pressures encountered at high altitudes and can be freighted internationally by air and is robust enough to be mailed back to a laboratory for analysis in a pre-addressed mailbox if necessary.
The capsule contains a tiny amount of labelled urea. The labelled urea is ultimately broken down by Helicobacter pylori releasing ammonia and labelled bicarbonate. The labelled material makes its way via the bloodstream to the lungs, where it's exhaled. Traces of the labelled material in the breath indicate a positive breath test result and the presence of a Helicobacter pylori infection.
The PYtest® was first registered (AUST R 67146) and commercialised in Australia in 1998 and is the largest selling breath test of its type to detect Helicobacter pylori internationally. The PYtest® was US-FDA approved in 1997.