A novel one-step Helicobacter pylori saliva antigen test

作者:Yang Bi Ling; Yeh Chun*; Kwong Wei Gang; Lee Shou Dong
来源:Journal of the Chinese Medical Association, 2015, 78(2): 96-100.
DOI:10.1016/j.jcma.2014.11.004

摘要

Background: A rapid, reliable, and sufficiently accurate test for diagnosing Helicobacter pylori infection is required for screening dyspeptic patients before a referral for endoscopy. The purpose of this article is two-fold: first, to evaluate the accuracy of a one-step H. pylori saliva antigen (HPS) test; and second, to compare noninvasive and invasive H. pylori tests in Taiwanese population. Methods: A total of 104 consecutive dyspeptic patients admitted for gastroenterology into the outpatient department underwent a one-step HPS test, rapid urease test, histology, and C-13-urea breath test C-13-UBT (proto C-13 urea kit). The accuracy of the HPS test was compared with a gold standard defined by at least two positive H. pylori test results from three H. pylori tests (histology, rapid urease test, and C-13-UBT). Results: The 104 patients eligible for analysis (mean age: 58 years, range 22-87 years), 21(20%) were gold standard positive. Among them, the positive of the one-step H. pylori saliva Ag test, rapid urease test, C-13-UBT, histology were (52; 50%), (17; 16%), (27; 25%) and (22; 21%) respectively. The sensitivity and specificity of the HPS tests, rapid urease test, C-13-UBTs, and histology were 71.43% and 55.42%, 76.19% and 98.80%, 100% and 92.77%, and 85.71% and 95.18%, respectively, relative to the gold standard. The one-step HPS test exhibited a sensitivity of 71.43%, nearly equivalent to that of the rapid urea test. Conclusion: The one-step HPS test exhibited a high sensitivity and low specificity compared with the other tests, indicating that it is not sufficiently accurate for use in a clinical setting for diagnosing H. pylori infection. However, the test is simple to use (requiring only a saliva sample), inexpensive, and noninvasive in its application, and thus appealing for use in population-based prevalence surveys of the epidemiology of H. pylori infection.

  • 出版日期2015-2