1. Evaluation of a new immunochromatographic based whole blood near patient test for the diagnosis of Helicobacter pylori infection
- Author
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S Reichenberger, H D Schwöbel, S Heuer, H Neuhaus, J Langhorst, and F U Drouven
- Subjects
Adult ,Male ,medicine.medical_specialty ,Peptic Ulcer ,Adolescent ,Spirillaceae ,Chronic gastritis ,Rapid urease test ,Enzyme-Linked Immunosorbent Assay ,Gastroenterology ,Helicobacter Infections ,Predictive Value of Tests ,Stomach Neoplasms ,Internal medicine ,Gastroscopy ,Medicine ,Humans ,Prospective Studies ,Child ,Aged ,Aged, 80 and over ,Immunoassay ,Chromatography ,medicine.diagnostic_test ,biology ,Helicobacter pylori ,business.industry ,Esophagogastroduodenoscopy ,Gastric lymphoma ,Middle Aged ,medicine.disease ,biology.organism_classification ,Antibodies, Bacterial ,Predictive value of tests ,Gastritis ,Immunology ,Female ,medicine.symptom ,business - Abstract
Background Infection with H pylori is very common and may cause chronic gastritis, predisposes to gastric and duodenal ulcers, leads in some cases to gastric lymphoma and has been recognised as a class I gastric carcinogen. Rapid, inexpensive, reliable tests are needed to facilitate the diagnosis. Methods This prospective clinical study was undertaken to evaluate a new whole blood antibody test (helicoCare) in correlation to three tests for diagnosis of H pylori infection (histology, ELISA and rapid urease test). 304 patients (mean age 56.5 years, range of 11-93 years) referred for esophagogastroduodenoscopy were included in this uni-centric study over a nine-month period. According to the guidelines for clinical trials in H pylori infection, patients with at least two positive tests were classified as positive for H pylori. Results 132 patients (43.4 %) were positive for H pylori, of which helicoCare identified 118 missing one gastric and one duodenal ulcer. 172 patients (56.6 %) were H pylori negative, of which helicoCare identified 163. Sensitivity was proven to be 89.4 % and specificity 94.8 %. In a special subgroup of 75 patients younger or equal to 45 years, 28 patients were positive for H pylori (37.3 %). In this group a sensitivity of 85.7 % and a specificity of 97.9 % was found for the helicoCare. Conclusions The helicoCare test showed sufficient sensitivity and satisfying specificity for H pylori diagnosis similar to or better than those of rapid urease test or ELISA. The helicoCare whole blood test may be useful for in-office H pylori diagnosis especially in patients under 45 years.
- Published
- 2002