Objectives: To compare the accuracy of common commercial serological kits for Helicobacter pylori and to ascertain factors affecting accuracy.
Methods: A comprehensive MEDLINE and manual search strategy was used to identify all articles comparing two or more kits. Each article was critically appraised for sample characteristics, study design, and data handling. The data comparing accuracy of the kits was analyzed by standard statistical methods as well as summary receiver operator characteristic curves (sROCs). A sROC also was used to estimate overall test accuracy and to identify factors affecting the measurement of accuracy.
Results: The 21 studies identified were of varying quality, but our analyses suggested that different commercial kits did not have significantly different accuracy. Overall, at a sensitivity of 85%, specificity was estimated to be 79%. Test accuracy measured was significantly higher in studies with smaller proportions of infected patients.
Conclusions: There is little evidence in the literature to suggest that any one of the common commercial serological kits is more accurate than any other. The overall accuracy of these kits may not be adequate for clinical decision-making in all patient groups.