The Urea Breath Test (UBT) is a simple, non-invasive, and accurate method for detecting Helicobacter pylori (H. pylori) infection. The test’s idea is straightforward. The enzyme urease of H. pylori hydrolyzes the orally administered urea, which is isotopically labelled with 14C or 13C, and *CO2 is exhaled. The test with the stable isotope 13C should be favoured, despite the low radiation exposure (3*10(-6) Sv. Many improvements have been made to the exam since it was first detailed in 1987. For both, the majority of studies obtained sensitivity and specificity figures of 95–100 percent. It would be excellent if there was a standard test protocol for the test meal, the proper 13C-urea dose, and the number of breath samples to be taken.
The global urea breath test market is estimated to be valued at US$ 110.7 Mn in 2021, and is expected to exhibit a CAGR of 5.1% over the forecast period (2021–2028). Various guidelines have been implemented by regulatory authorities for manufacturing of medical devices to avoid the spread of COVID-19. For instance, The European Commission recently adopted a proposal on April 3, 2020, to postpone the application date of the Medical Device Regulation (MDR) for one year due to the COVID-19 pandemic. The functionality of the European Database on Medical Devices (EUDAMED) was announced on May 26, 2021, based on this proposal.
The global urea breath test market is divided into five regions: North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa. Due to an increasing number of inorganic growth tactics such as distribution agreements, North America is likely to have a prominent position in the worldwide urea breath test market over the forecast period. For example, Biomerica Inc., a global biomedical firm, said in June 2021 that it had inked an exclusive five-year distribution agreement with a Canadian partner for Biomerica’s innovative and unique Helicobacter pylori test, termed hp+detect, distribution and marketing. For the detection and monitoring of H. pylori infection, the hp+detect product was created.
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