Accuracy of a new innovative column-free miniaturized gas-mass spectrometer compared with a classic gas-mass spectrometer to diagnose and monitor Helicobacter pylori infection: a prospective single blind study

Background Helicobacter pylori (H. pylori) is one of the most common bacterial infections, and it causes chronic gastritis, peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. H. pylori infection can be essentially detected by invasive [i.e. requiring an upper gastrointestinal endoscopy (UGE)], and noninvasive techniques. The principle of the urea breath test exploits the abundant quantities of urease produced by H. pylori. Recently, advances in the field of micro-electromechanical systems and nano-electromechanical systems have been proposed. This study aimed to evaluate the accuracy of this new miniaturized column-free portable gas-mass spectrometry (GMS) test compared with the standard GMS to diagnose H. pylori infection before and after eradication therapy. Methods Consecutive patients never treated for H. pylori infection and referred to our unit to perform a UGE between April and November 2024 were evaluated for this blind prospective trial. Patients’ samples were analysed with both methods and data were compared. Results A total of 28 patients were enrolled and 92 were H. pylori positive. The data obtained from the two tests were compared, and no statistically significant difference was observed. Discussion Our experience highlights the potential for introducing new diagnostic tools that are less demanding in terms of cost and labour, without compromising diagnostic accuracy. To our knowledge, this is the first time that an innovative diagnostic tool proves to be as compact and as reliable; for this reason, it deserves to be implemented in clinical practice.