Good Diagnostic Accuracy of a Chemiluminescent Immunoassay in Stool Samples for Diagnosis of Helicobacter Pylori Infection in Patients with Dyspepsia

Abstract

Laboratory-based chemiluminescence immunoassays (CLIA) are widely used in clinical laboratories. Some years ago, a CLIA test was developed for the detection of Helicobacter pylori in stool samples, known as LIAISON H. pylori SA, but little information on its use has been reported. To evaluate the accuracy of the LIAISON H. pylori SA assay for diagnosing H. pylori infection prior to eradication treatment. Diagnostic reliability was evaluated in 252 untreated consecutive patients with dyspepsia. The gold standard for diagnosing H. pylori infection was defined as the concordance of the rapid urease test (RUT), histopathology and urea breath test (UBT). The CLIA assay was performed according to the manufacturer's instructions. Sensitivity, specificity, positive and negative predictive values, and 95% CIs were calculated. According to the gold standard selected, 121 patients were positive for H. pylori infection and 131 negative. LIAISON H. pylori SA had a sensitivity of 90.1% and a specificity of 92.4%, with positive and negative predictive values of 91.6% and 90.1%, respectively. The accuracy of the LIAISON H. pylori SA chemiluminescent diagnostic assay seems comparable to that of ELISA or the best-performing LFIAs. Its sensitivity and specificity, however, seem slightly lower than those of histology, RUT or UBT. The advantages of the assay are that it is cheap, automated, and minimally labor-intensive.