Evaluation of a Novel Stool Antigen Rapid Test Kit for Detection of Helicobacter pylori Infection.

ABSTRACT

The Quick Chaser H. pylori (QCP), which is a novel antigen detection kit for Helicobacter pylori, was developed recently. The previous examination kits targeted the catalase of H. pylori; however, this new test kit, to the best of our knowledge, is the first kit to target the flagellar protein of H. pylori The present study aimed to evaluate the efficacy of QCP compared with that of the already commercially available rapid test kit Testmate Rapid Pylori Antigen (TRP). TRP and QCP were utilized in 71 participants. The positive and negative concordance ratios of QCP to TRP were 100% (57/57) and 92.9% (13/14), respectively. Sensitivity based on the rapid urease test and culture test was 92.3%. Results of the dilution sensitivity test showed that QCP was eight times more sensitive to an H. pylori standard strain and the clarithromycin (CAM)-resistant clinical isolate and four times more sensitive to a CAM-susceptible clinical isolate than TRP. For the cross-reactivity test, 27 strains that exist in human feces, such as the Helicobacter genus, Bifidobacterium genus, Lactobacillus genus, and other resident bacteria, were selected. The results obtained using QCP were all negative, and no cross-reaction was observed. In conclusion, compared with TRP, QCP can detect H. pylori using clinical specimens with high sensitivity, regardless of CAM susceptibility and tolerance. No cross-reactivity was observed with other intestinal bacteria in humans. The kit is considered extremely useful in clinical settings.