Urea breath test (H. pylori)
A urea breath test detects Helicobacter pylori infection by measuring labelled carbon dioxide in breath after the patient swallows labelled urea. Gastroenterology clinics, hospitals and laboratories use it because it is non-invasive.
Common types
- 13C urea breath test: uses a stable, non radioactive isotope and is measured by infrared spectroscopy or mass spectrometry.
- 14C urea breath test: uses a small dose of radioactive isotope and is measured by a scintillation counter.
- Breath test analyser: the instrument that reads the breath samples.
- Test kit: urea capsule or powder plus breath collection bags or tubes.
- Point of care breath analyser: compact unit for clinics.
What to tell us when you ask for a quotation
- 13C or 14C method
- Analyser throughput and number of sample ports
- Kit contents: urea dose, collection bags, labels
- Compatibility between kits and analyser
- Printer, software and power plug type
- Storage and shelf life of kits
- Quantity, destination country and the delivery terms you want (for example EXW, FOB or CIF).
Documents to ask for
The labelled urea (13C or 14C) is usually registered as a medicinal product, for example in the EU and the US, while the breath analyser and collection accessories need CE marking or the destination country's device or IVD registration and ISO 13485 for the maker. 14C kits also need the national radiation authority's import or use approval.
Certificates and registrations belong to the product and its manufacturer. We check them with you against the rules of your market before any order.
What is the difference between 13C and 14C urea breath tests?
The 13C test uses a stable, non-radioactive isotope and is read on an infrared or mass spectrometry analyser. The 14C test uses a small radioactive dose, which in many countries needs a licence to store and handle. Which test a facility uses is a clinical and regulatory choice in the buyer's country.
Send us the specification and quantity. We compare manufacturers in China and reply with options, lead times and the documents that come with each product. NJMC sources and checks; it does not manufacture.