Evaluation of three commercial enzyme immunoassays compared with the 13C urea breath test for detection of Helicobacter pylori infection

Abstract

The diagnostic significance of the serological detection of antibodies to Helicobacter pylori has been established by numerous investigators. Reports of the clinical reliabilities of commercial enzyme immunoassay (EIA) kits available for this purpose vary as a result of the different H. pylori antigen sources and reference methods used. The 13 C urea breath test (UBT) has been shown to be an extremely accurate and reliable method of detecting H. pylori infection. We used the 13 C urea breath test as the confirmatory method for H. pylori status to evaluate three commercially available EIA kits designed to detect immunoglobulin G antibodies to H. pylori. These kits were the HM-CAP EIA kit (Enteric Products, Inc.), the PYLORI STAT EIA kit (BioWhittaker, Inc.), and the G.A.P. kit (Bio-Rad Laboratories/Biomerica, Inc.). The evaluations were performed in a double-blind manner with samples from 473 clinically characterized patients. This group included patients with symptomatic gastrointestinal disorders as well as nonsymptomatic volunteers. The sensitivities of the kits were as follows: HM-CAP, 98.4%; PYLORI STAT, 99.2%; and G.A.P., 100%. The specificities were as follows: HM-CAP, 96.4%; PYLORI STAT, 90.1%; and G.A.P., 26.0%. Although the HM-CAP and PYLORI STAT kits performed comparably, the G.A.P. test yielded significantly more false-positive results and an unacceptably high number of indeterminate results.

Evaluation of five commercial serological tests for the detection of Helicobacter pylori infection in Chinese

“…The GAP IgG test has a wide grey zone of 19%; this is echoed by other investigators demonstrating grey zones of 17.3% and 12%, bringing the accuracy of the test into question 11 , . 5 Two studies reported specificities of 26% and 29%, with another reporting a sensitivity of only 50% 11 , . 12 , 13 …”

Utilization of Proteinase K‐Treated Cells as Lipopolysaccharide Antigens for the Serodiagnosis of Helicobacter pylori Infections

“…Meijer et al (15) compared eight commercial kits and suggested that these kits may be useful in diagnosing H. pylori infection in addition to biopsy-based methods. Similarly, Lozniewski et al (12), Marchildon et al (13), and Chen et al (6) reported the usefulness of serodiagnosis for detecting H. pylori infection. Furthermore, Nilsson et al (20) described an immunoblot assay using acid glycineextracted cell surface proteins of H. pylori that included 110/120 kDa and some low molecular mass proteins as antigens.…”

Long-term Follow-up Study of Serum Immunoglobulin G and Immunoglobulin A Antibodies After Helicobacter pyloriEradication

“…On the other hand, noninvasive serology and 13 Curea breath test have the same diagnostic accuracies as biopsy-based tests for detecting H pylori infection. 4,5 Because the serum immunoglobulin G (IgG) test has showed high sensitivity and specificity, 6,7 the serology test has been used widely in epidemiologic studies and routine diagnosis of H pylori infection. Although most previous serologic studies have used noncommercial enzyme immunoassay (EIA) methods for IgG antibodies to H pylori, several commercial EIA kits are now available.…”

“…Although most previous serologic studies have used noncommercial enzyme immunoassay (EIA) methods for IgG antibodies to H pylori, several commercial EIA kits are now available. 7,8 Generally, it is thought that H pylori infection persists for a lifetime and that the serum IgG antibody level remains high. Although spontaneous elimination of H pylori can occur, it is infrequent.…”