Evaluation of a commercial ELISA for serodiagnosis of Helicobacter pylori infection

• Published in: Journal of clinical pathology Vol. 44; no. 4; pp. 326 - 328
• Main Authors: Crabtree, J E, Shallcross, T M, Heatley, R V, Wyatt, J I
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and Association of Clinical Pathologists 01.04.1991; BMJ; BMJ Publishing Group LTD
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Bacterial - analysis; Biological and medical sciences; Biotechnology; Enzyme-Linked Immunosorbent Assay; Evaluation Studies as Topic; Female; Fundamental and applied biological sciences. Psychology; Health. Pharmaceutical industry; Helicobacter Infections - diagnosis; Helicobacter pylori - immunology; Humans; Immunoglobulin G - analysis; Industrial applications and implications. Economical aspects; Male; Middle Aged; Predictive Value of Tests; Sensitivity and Specificity; Human; Stomach; Spirillales; Spirillaceae; IgG; Exploration; Infection; Immunological investigation; Bacteriosis; Digestive diseases; Bacteria; Diagnosis; ELISA assay; Campylobacter
• ISSN: 0021-9746; 1472-4146
• DOI: 10.1136/jcp.44.4.326

A commercial ELISA for the detection of Helicobacter pylori IgG antibodies was evaluated using serum from 242 patients attending an endoscopy clinic. The efficacy of the ELISA was assessed in relation to the histological detection of H pylori on antral mucosal biopsy specimens. In patients under 61 years of age (n = 138) the ELISA was 97.5% sensitive and 85.5% specific for H pylori infection, with a positive predictive value of 91% and a negative predictive value of 96%. Over the whole group the sensitivity of the ELISA was 93.8% and the specificity 79.3%. The positive predictive value and negative predictive values were, respectively, 90% and 87%. These results suggest that the Bio-Rad GAP IgG H pylori ELISA is suitable for serodiagnosis of H pylori infections for most clinical purposes and thus makes H pylori serology available to routine diagnostic laboratories.