An evaluation of the performance of a novel stick-type kit for rapid detection of Helicobacter pylori antibodies in urine.

Background: ODK-0702 is a stick-type urinary Helicobacter pylori (H. pylori) antibodies detection kit, developed to improve the original housing type urinary H. pylori antibodies detection kit "RAPIRUN (R) H. pylori Antibody". This stick-type kit is designed for the efficient daily medical practice at hospital or clinic, public or school health checkup, to detect H. pylori infection. The aim of this study was to evaluate the performance and correlation of this kit with the original kit and the ELISA kit. Methods: Control kits were "RAPIRUN (R) H. pylori Antibody" (Kit A) and "URINELISA (R) H. pylori Antibody" (Kit B). Urine samples were obtained from 249 subjects scheduled for upper endoscopy, 99 subjects suspected of having upper gastrointestinal disease, and 150 subjects receiving health checkups. Rates of agreement in results between ODK-0702 and the control kits were investigated. Results: High agreement rates of 98.4 % (245/249) and 88.8 % (221/249) were found between ODK-0702 and the kits, Kit A and B, respectively. In patients, the agreement rates of ODK-0702 as compared to Kit A and B were 99.0 % (98/99) and 88.9 % (88/99), respectively. In control subjects, the agreement rates of ODK-0702 as compared to Kit A and B were 98.0 % (147/150) and 88.7 % (133/150), respectively. Conclusions: ODK-0702 enabled rapid testing within 15 minutes and showed equivalent performance as control kits, being clinically very useful in the diagnosis of H. pylori infection. (Clin. Lab. 2011;57:481-487)