The Comparison of HP(TM) Test, a New Domestically Manufactured Rapid Urease Test, with CLO(TM) Test

Yim, Jeong Yoon; Ahn, Young Mee; Kim, Doe Young; Moon, Il Whan

Abstract

Although CLO test is one of the most commonly used rapid urease test for the diagnosis of Helicobacter(H.) pylori infection. Recently a Korean company, Jongkeundang, has succeeded in manufacturing the rapid urease test and named it as HP(TM) test. The advantages of HP test are to have two agar gels in a plate and react faster in despite of same cost with CLO test. We performed this study to compare the results of the HP test with those of the CLO test and know if there is any advantage of using two biopsy samples instead of using only one sample. One hundred and eight patients underwent gastroscopy and two biopsy specimens from the greater curvature of the antrum was used for HP test and CLO test. Another biopsy specimen from lesser curvature of midbody was used for HP test. We read them at 20min, 1hour, 3hours, and 24hours. The positive rate of HP test in antrum was 49.1%(53/108) which was the same as CLO test in antrum. The concordance rate of the results of two tests in the same site(antrum) were 98.2%. In terms of a time change to a positive test, both tests were not significantly different with each other. ; 3hour positive rate of HP test was 94.4% and that of HP test was 92.5%. Four patients(5.6%) performed HP test had positive results after 2hours known final reading time. The positive rate of HP test in body was 52.8%(57/108) and that of HP test in antrum or body was 53.7%(58/108). The concordance rate of the results of antrum and body in HP test was 94.4%. Five of the negative HP test in antrum(4.7%) had positive results in gastric body. They were negative CLO test in antrum. In conclusion, HP test was thought to be as valuable as CLO test for the diagnosis of H. pylori infection and has a merit of decreasing sampling error by using two samples, even though it is a little. However, It had not quicker time to positivity than CLO test and might have false negative results if it were read at 2hours after reaction. So, Final reading time should be reevaluated.