How useful is the Urinary Rapid Test for the Diagnosis of Helicobacter Pylori?

Abstract

There is increasing interest in noninvasive tests for the diagnosis of Helicobacter pylori [H. pylori] infection. One such test, a urine-based rapid test kit [RAPIRUN H. pylori antibody] for detection of H. pylori antibodies, has been developed and was considered as an ideal test by many authors due to its non-invasiveness, safe handling due to use of urine as a sample, and the assay procedure is very simple. Only 10-20 minutes are required to complete an assay, and no instruments are needed. Hence, this study aimed at evaluating the accuracy of this kit compared to gold standard histology, rapid urease test [invasive], and saliva H. pylori antibody test using ELISA kit [non- invasive]. The study included 102 patients who underwent endoscopy because of clinical symptoms attributable to upper gastrointestinal tract. Two gastric biopsy specimens from all patients, unstimulated saliva [from 91 random patients], and random urine samples [from 65 patients] were collected. Histological examination of the gastric biopsy specimens [gold standard] revealed that 61 [59.8%] patients were H. pylori positive. Rapid urease test showed a sensitivity of 78.7%, specificity of 87.8%, positive predictive value [PPV] of 90%, negative predictive value [NPV] of 73.5%, and accuracy of 82.4%. Salivary antibody test was associated with sensitivity of 21.2%, specificity of 87.2%, PPV of 68.8%, NPV of 54.3%, and accuracy of 54.3% while urine antibody test [RAPIRUN H. pylori antibody] showed a sensitivity of 100%, specificity of 73.1%, PPV of 84.8%, NPV of 100%, and accuracy of 89.2%. Based on such results it can be concluded that RAPIRUN H. pylori antibody is a simple rapid completely noninvasive kit that showed an excellent sensitivity and negative predictive values of 100% and should be tried on a wide scale on the Egyptian population. On the other hand, it is not recommend to routinely use salivary antibodies as a means for H. pylori screening.