Analytical performance evaluation of the Helibac rapid urease test for detection of Helicobacter pylori urease activity under controlled laboratory conditions.

Helicobacter pylori infection remains one of the most prevalent chronic bacterial infections worldwide and is strongly associated with chronic gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and gastric carcinoma. Accurate diagnosis of infection is essential for successful therapy. Currently available diagnostic methods include both invasive and non-invasive approaches; however, none guarantees complete elimination of false-negative or false-positive results. This study aimed to evaluate the analytical performance of a Polish dry rapid urease test, the Helibac RUT for the detection of H. pylori infection and compare it with other commercially available urease tests. Reaction kinetics and detection thresholds were assessed using standardized bacterial suspensions and controlled experimental conditions applied to the Helibac RUT, CLO test, BIOHIT, and ENDOSC-Hp tests. The Helibac RUT also was compared with two other rapid urease tests manufactured in Poland. The evaluated test demonstrated lower analytical detection thresholds and faster reaction kinetics under controlled laboratory conditions compared with the comparator rapid urease tests. The results indicate promising analytical performance characteristics of the Helibac RUT system, including rapid color development and low analytical detection thresholds. These findings support further clinical performance studies using gastric biopsy specimens.