Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care.
BACKGROUND
Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.


METHODS
One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.


RESULTS
The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.


CONCLUSIONS
The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.
Lewin-van den Broek
N T
NT
Dept. of General Practice, and Julius Center for Patient Oriented Research, Faculty of Medicine, University of Utrecht, University Hospital, The Netherlands.
Numans
M E
ME
Buskens
E
E
de Wit
N J
NJ
Smout
A J
AJ
Verheij
T J
TJ
D000328:Adult; D004415:Dyspepsia / Q000382:microbiology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000706:statistics & numerical data*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity