Evaluation of the accuracy of two stool antigen tests for Helicobacter pylori infection

[摘要] Introduction:stool antigen tests have been considered to be promising for the diagnosisof Helicobacter pylori infection. For their incorporation into medicalpractice, it is indispensable to demonstrate their accuracy in a study population. Objective:evaluate the diagnostic capacity of the commercial systems ELISA SD and SDBIOLINE, Standards Diagnostics, Korea, in Cuban patients with gastroduodenalsymptoms.Methods:an evaluation was conducted of 101 stool samples from patients previouslyclassified as H. pylori positive and negative by reference histologicaltests and the rapid urease test. Estimation was made of performance parametersfor both diagnostic systems using the software EPIDAT 3.1.Results:Sensitivity for the systems ELISA SD and SD BIOLINE was 85.25 % and 75.41%, respectively. Specificity for both was 92.50 %. Positive and negative predictivevalues, validity and Youden's indices, and diagnostic reliability were satisfactoryfor both tests.Conclusions:the systems evaluated were found to have a performance level comparable withhistological tests and the rapid urease test for active detection of H.pylori infection. This confirms their usefulness for the diagnosis andtimely management of patients without having to use invasive tests.

[学科分类] 传染病学

[关键词] Helicobacter pylori;stool sample-based antigen detection.