Development of a New Liquid Type Rapid Urease Test Kit (Helicotest®): Comparison with Other Commercial Kits.

Abstract

A quick and accurate diagnosis of Helicobacter pylori (H. pylori) infections is vital for effectively managing many upper gastrointestinal tract diseases. Many diagnostic methods have been developed for rapid and accurate diagnosis, including invasive and non-invasive methods, but each tool has some limitations. Among the invasive diagnostic methods, the rapid urease test (RUT) is a relatively time-saving and accurate method, but a variation in the reaction time range causes inconvenience and inefficiency in the clinical field. This study developed a liquid-type medium, Helicotest®, to enable faster detection. This study examined the reaction time of a new liquid-type RUT kit with other commercial kits. Two H. pylori strains were cultured (H. pylori ATCC 700392 and 43504), and the urease activity of H. pylori was measured using a urease activity assay kit (MAK120, Sigma Aldrich). Four RUT kits were used to compare the time of H. pylori detection, including Helicotest® (Won Medical, Bucheon, Korea), Hp kit (Chong Kun Dang, Seoul, Korea), CLO kit (Halyard, Alpharetta, GA, USA), and ASAN Helicobacter Test® (ASAN, Seoul, Korea). The detection of H. pylori was possible in bacterial amounts less than 10 μL. The color change was detected from five minutes with bacterial densities of 5 μL and 10 μL for both strains, whereas 30 minutes and one hour were required for 0.5 μL and a 1 μL bacterial density of ATCC 43504 and 700392 strains, respectively. Compared to other RUT kits, Helicotest® showed the fastest reaction. Therefore, faster diagnosis in clinical practice is expected.