Validation of four Helicobacter pylori rapid blood tests in a multi-ethnic Asian population

To validate the accuracy of four rapid blood tests in the diagnosis of Helicobacter pylori.

Consecutive dyspeptic patients scheduled for endoscopy at the National University Hospital, Singapore, were interviewed and had blood drawn for serology. The first 109 patients were tested with BM-test (BM), Pyloriset Screen (PS) and QuickVue (QV), and the next 99 subjects were tested with PS and Unigold (UG). Endoscopies were performed blinded to rapid blood test results and biopsies were taken for culture and rapid urease test. Urea breath tests were performed after endoscopies. The rapid blood test results were compared with four reference tests (rapid urease test, culture, serology, and breath test).

The study population composed of 208 patients (mean age 43.1 years; range 18-73 years; 119 males; 174 Chinese). The number of evaluable patients for BM, QV, UG and PS were 102, 102, 95, and 197, respectively. The sensitivity and specificity, respectively were: PS 80.2%, 95.8%; UG 55.9%, 100%; QV 43.3%, 100%; BM 67.2%, 97.1%.

The rapid blood test kits showed high specificity and positive predictive value (97-100%), while sensitivity and negative predictive value ranged widely (43%-80% and 47%-73%, respectively). Among test kits, PS showed the best sensitivity (80%), best negative predictive value (73%) and best negative likelihood ratio (0.207). PS had a specificity of 96%, positive predictive value of 97% and positive likelihood ratio of 19.1.