Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis.
OBJECTIVE
To perform a systematic review and a meta-analysis of accuracy of monoclonal stool antigen test (SAT) for the diagnosis of Helicobacter pylori infection.


METHODS



METHODS
assessing the accuracy of monoclonal SAT for the diagnosis of H. pylori infection.


METHODS
electronic and manual bibliographical searches.


METHODS
independently done by two reviewers.


RESULTS
meta-analyses combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies.


RESULTS
Twenty-two studies, including 2,499 patients, evaluated the monoclonal SAT before eradication therapy. Pooled sensitivity, specificity, LR+, and LR- were: 0.94 (95% CI 0.93-0.95), 0.97 (0.96-0.98), 24 (15-41), and 0.07 (0.04-0.12). The accuracy of both monoclonal and polyclonal SAT was evaluated together in 13 pretreatment studies, and higher pooled sensitivity was demonstrated with the monoclonal technique (0.95 vs 0.83). Twelve studies, including 957 patients, assessed the monoclonal SAT to confirm eradication after therapy. Pooled sensitivity, specificity, LR+, and LR- were 0.93 (0.89-0.96), 0.96 (0.94-0.97), 17 (12-23), and 0.1 (0.07-0.15). Both tests were evaluated together in eight post-treatment studies and, again, the monoclonal technique showed higher sensitivity (0.91 vs 0.76). Heterogeneity among studies disappeared when a single outlier study was excluded. Subanalysis depending on the reference method, the study population, or the study quality showed similar results.


CONCLUSIONS
Monoclonal SAT is an accurate noninvasive method both for the initial diagnosis of H. pylori infection and for the confirmation of its eradication after treatment. The monoclonal technique has higher sensitivity than the polyclonal one, especially in the post-treatment setting.
Gisbert
Javier P
JP
Department of Gastroenterology, "La Princesa" University Hospital, Universidad Autónoma, Madrid, Spain.
de la Morena
Felipe
F
Abraira
Víctor
V
D000942:Antigens, Bacterial / Q000032:analysis*; D005243:Feces / Q000382:microbiology*; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D012680:Sensitivity and Specificity
D000942:Antigens, Bacterial