ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the accuracy of the Helicobacter pylori (H. pylori) stool antigen (HpSA) test and ImmunoCard STAT HpSA in the primary diagnosis of H. pylori infection.</p><p><b>METHODS</b>We searched Medline (1966-2007.4), EMbase (1985-2007.4), Chinese Journals Full-text Database (CJFD) (1994-2007) etc. to identify Clinical Trials of ImmunoCard STAT HpSA for the primary diagnosis of H. pylori infection. Meta-analysis was conducted using the method recommended by The Cochrane Collaboration Center.</p><p><b>RESULTS</b>Eleven trials were included with pooled sensitivity, pooled specificity as 0.93 (95% CI: 0.91-0.94), 0.93 (95% CI: 0.90- 0.95), respectively. Pooled positive likelihood ratio and pooled negative likelihood ratio were 12.01 (95% CI: 8.90-16.19), 0.08 (95% CI: 0.07-0.11), respectively with the pooled diagnostic odds ratio as 160.14(95% CI :100.43-255.34). The area under the summary receiver operating characteristic (SROC) was 0.974 +/- 0.005.</p><p><b>CONCLUSION</b>ImmunoCard STAT HpSA appeared to be an accurate non-invasive method for the initial diagnosis of H. pylori infection.</p>