Comparison of three commercially available enzyme-linked immunosorbent assays and biopsy-dependent diagnosis for detecting Helicobacter pylori infection

Abstract

We evaluated the performance of three enzyme-linked immunosorbent assays (ELISAs) in detecting serum immunoglobulin G (IgG) and IgA antibodies to Helicobacter pylori; two were new ones from Pyloriset (Pyloriset EIA-G update and Pyloriset EIA-A update; Orion Diagnostica, Espoo, Finland), and the third was the Malakit EIA-G (Biolab, Limal, Belgium). Serum samples from 154 dyspeptic patients were collected. As a reference method, multiple biopsy specimens from different anatomical areas of the stomach were obtained by endoscopy and were analyzed by culture and/or histology and direct urease testing. Accordingly, 126 patients (82%) were found to be H. pylori positive and 28 patients (18%) were found to be H. pylori negative. To validate serology as a predictor of H. pylori infection, sensitivity, specificity, positive and negative predictive values, and accuracy of the assays were calculated against the H. pylori status as determined by the reference method. The corresponding data for the different ELISAs were 100%, 79%, 95%, 100%, and 96% for the Pyloriset EIA-G update, 81%, 89%, 97%, 52%, and 82% for the Pyloriset EIA-A update, and 87%, 86%, 96%, 60%, and 87% for the Malakit EIA-G, respectively. We conclude that the Pyloriset EIA-G update is a reliable and accurate test and that because of its 100% sensitivity, conjunctional IgA testing is not necessary. Its 100% negative predictive value makes it a very useful screening test. For purposes of excluding infection with H. pylori, the performance of the Malakit EIA-G is moderate but can be improved by conjunctional IgA testing. The Pyloriset EIA-A update can be useful as such a conjunctional test.

Detection of Immunoglobulin G and M Antibodies to Helicobacter Pylori in Serum by an Enzyme Immunoassay Method

“…Serodiagnostic tests permit the rapid, noninvasive, sensitive, and specific detection of H. pylori (28,29). Serological detection of H. pylori antibodies by well formulated and standardized tests such as ELISA has the ability to replace endoscopy as the diagnostic procedure of choice (30). ELISA is one of the most extensively employed tests, because it is relatively inexpensive, quick, easy to perform, suitable for screening large populations, and capable of detecting class-specific immunoglobulins (31,32).…”

Use of Immunoblot Assay To Define Serum Antibody Patterns Associated with Helicobacter pylori Infection and with H. pylori -Related Ulcers

“…Serology is now widely used as a global method of diagnosis, and a variety of commercially available kits (27) or homemade methods (14) have been described. Most of these methods provide satisfactory results (1,15,20,27,37,43); however, significant improvements must be made before they can be considered as reference methods. Improvement of the antigenic preparations is the best way to improve the performances of the serological methods, but to date, there is no consensus as to the most appropriate composition of the preparations.…”

“…The diagnosis of H. pylori gastric infection can be conducted by using direct (invasive) or indirect (noninvasive) methods (28). Among the indirect methods, serology is a valuable tool for seroepidemiological studies (43,45) or for posttreatment follow-up (46). The serological assays are, essentially, enzyme immunoassays (EIAs) with a variety of antigenic preparations.…”

Comparison of Endoscopy-Based and Serum-Based Methods for the Diagnosis ofHelicobacter pylori

“…It has some important advantages compared with other diagnostic methods because it is simple and inexpensive, and no major equipment is required. Commercial serological assays for detection of serum IgG and IgA WC antibodies have variable sensitivity and specificity mainly because they are based on various antigen preparations (1,(5)(6)(7). For this reason, it is necessary to assess the diagnostic utility of these methods before using them to determine the prevalence of H pylori in a particular geographic location.…”