Evaluation of a new immunochromatographic based whole blood near patient test for the diagnosis of Helicobacter pylori infection.
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.
Langhorst
J
J
Evangelisches Krankenhaus, Düsseldorf, Germany. j.langhorst@kliniken-essen-mitte.de
Heuer
S
S
Drouven
F U
FU
Schwöbel
H D
HD
Reichenberger
S
S
Neuhaus
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D002648:Child; D002845:Chromatography; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005756:Gastritis / Q000175:diagnosis* / Q000276:immunology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000175:diagnosis* / Q000276:immunology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000276:immunology
D000907:Antibodies, Bacterial