Source: FDA, National Drug Code (US) Revision Year: 2020
PYtest1 (14C-Urea Breath Test) is a qualitative and non-invasive method for the diagnosis of Helicobacter pylori (H.pylori). To detect H.pylori, 14C-urea supplied in a capsule is swallowed by the patient. If gastric urease from H.pylori is present, Urea is split to form CO2 and NH3. Ten minutes after the patient ingests the capsule, a breath sample is collected into a balloon. The breath sample is later transferred to collection fluid to trap the labeled CO2. The liquid sample is then analyzed in a liquid scintillation counter.
The PYtest1 Kit (14C-Urea Breath Test) is designed for use with the PYtest1 capsule, a gelatin capsule for oral administration containing 1 µCi of 14C labeled urea. The urea is adsorbed on sugar spheres and colored yellow with fluorescein.
Structural Formula (14C-urea): NH214CONH2
Radiation emission: beta-emission, 49 keVmean, 156 keVmax, no other emissions
External emission: No external radiation hazard. Low-energy beta emissions only. Maximum range of 0.3 mm in water.
Radiological Half-life: 5730 years
Maximum effective dose equivalent (EDE): 0.3 mrem/µCi
| How Supplied |
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PYtest1 Kit (14C-Urea Breath Test) is supplied as a kit containing a PYtest1 Capsule, a clear gelatin capsule containing 1µCi of 14C--urea and breath collection equipment. PYtest1 Capsules are also supplied separately in unit dose packages of 1,10 and 100. The PYtest1 Capsule has a shelf life of two years. The expiration date is printed on the capsule label. Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076 USA |
| Drug | Countries | |
|---|---|---|
| PYTEST | Singapore, Turkey, United States |
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