Following FDA clearance of the IDkit:HpTM One kits (using the identical 13C-urea tablet and Citrica powder), the following adverse events have been identified: anaphylactic reaction, diarrhea and vomiting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a casual relationship to drug exposure. In two clinical studies conducted in 465 patients' of at least 18 years-old and older to determine the initial diagnosis and post treatment monitoring of H. pylori infection using the IDkit HpTM Two kits, the following adverse events experienced by 1.5% of those patients were nausea (0.6%), throat burning (0.4%), and lightheadedness (0.4%). The last one was reported after blowing into the bags. The potential for adverse events were experienced by the patients within minutes of the 13C-Urea tablet and Citrica powder.
H. Pylori Breath Test
The H. Pylori Breath Test measures bacteria in the stomach that is associated with most stomach ulcers. Heliobacter pylori (H. pylori) is a bacteria which lives only in the lining of the stomach and is one of the most common chronic infections in humans. H. Pylori is associated with most stomach ulcers and most all duodenal ulcers. The H. Pylori Breath Test is used to detect the bacteria.
The test consists of two phases, the Sampling phase, at which time two Breath Sample Bags are inflated by the patient, and the Analysis phase at which time the two Breath Sample Bags are analyzed together using the BreathID Hp Lab System. Sampling phase begins with the collection of a baseline breath sample. The patient inflates the Baseline Breath Sample Bag. The patient then ingests a test drink consisting of 13 C-urea tablet 75mg and 4.3g of Citrica Powder (4g citric acid). After 15 minutes a post-ingestion sample is collected by inflation of the Post Ingestion Breathe Sample Bag. The average adult body normally contains about 9.0 grams of urea, which is a product of protein metabolism. Urea in the body is referred to as a natural isotopic abundance urea since it is composed of 98.9% 12C-urea and 1.1% 13C-urea. Greater than or equal to 99% of the carbon molecules in the supplied tablet are in the form of 13C; a stable, naturally occurring, non-radioactive isotope of carbon. 13C-urea is the diamide of 13C carbonic acid and is highly soluble in water.
The test takes approximately 20 minutes.