Background & Aims: Ultrasound-based transient elastography is a promising noninvasive alternative to liver biopsy for detecting hepatic fibrosis. However, its overall test performance in various settings remains unknown. The aims of this study were to perform a systematic review and meta-analysis of diagnostic accuracy studies comparing ultrasound-based transient elastography with liver biopsy for hepatic fibrosis. Methods: Electronic and manual bibliographic searches to identify potential studies were performed. Selection of studies was based on reported accuracy of ultrasound-based transient elastography compared with liver biopsy. Data extraction was performed independently by 2 reviewers. Meta-analysis combined the sensitivities, specificities, and likelihood ratios of individual studies. Extent and reasons for heterogeneity were assessed. Results: Nine studies in full publication were identified. For patients with stage IV fibrosis (cirrhosis), the pooled estimates for sensitivity were 87% (95% confidence interval [CI], 84%-90%), specificity 91% (95% CI, 89%-92%), positive likelihood ratio 11.7 (95% CI, 7.9-17.1), and negative likelihood ratio 0.14 (95% CI, 0.10-0.20). Among 7 investigations reporting patients with stages II-IV fibrosis, the pooled estimates for sensitivity were 70% (95% CI, 67%-73%), specificity 84% (95% CI, 80%-88%), positive likelihood ratio 4.2 (95% CI, 2.4-7.2), and negative likelihood ratio 0.31 (95% CI, 0.23-0.43). Diagnostic threshold (or cut-off value) bias was identified as an important cause of heterogeneity for pooled results in both patient groups. Conclusions: Ultrasound-based transient elastography appears to be a clinically useful test for detecting cirrhosis. © 2007 AGA Institute.