Evaluation of a locally-made urease test for detecting Helicobacter pylori infection

We studied the efficacy of a home-made urease test (HUT) in the detection of Helicobacter pylori (HP) infection in patients undergoing upper gastrointestinal endoscopy. In the first phase of the study, two antral biopsies each were obtained from 43 patients for urease tests using the CLOtest and a home-made buffered 2% urea solution with phenol red as indicator at pH 6.8 (2% HUT). Twenty-six patients (60.5%) were HP positive, both by the 2% HUT and CLOtest with 100% concordance. In the second phase of the study three antral biopsies each and blood were obtained from 42 patients for the determination of HP status using a 10% HUT and a combination of culture and serology. Twenty-three patients (54.8%) were HP positive using the 10% HUT, while 32 patients (76.2%) were positive using the combination of 2 tests. Compared to this the sensitivity and specificity of the 10% HUT were 72% and 100% respectively. The CLOtest produced a colour change in a shorter time than the 2% and 10% HUT (median 1 hour versus 10 hours versus 16 hours p < 0.0001). In the third phase of the study, we observed that by doubling the biopsy size, the time required to obtain a colour change was significantly reduced (median 4.5 hours versus 10 hours p < 0.05). The HUT is easy to prepare, cheap, sufficiently sensitive and it is reliable enough to start treatment when positive. With 100% concordance and 1% the cost per test when compared to the commercially available CLOtest; the 10% HUT is hereby recommended for the detection of UP infection in our region.