OBJECTIVETo evaluate the pooled diagnostic accuracy of contrast-enhanced ultrasound (CEUS) to differentiate benign and malignant breast lesions.MATERIALS AND METHODSElectronic databases of PubMed, Embase, and the Cochrane Library were searched for potentially eligible studies throughout January 2022. The potential effects of publication year, country, mean age, and contrast agents on the diagnostic accuracy of CEUS were also assessed.RESULTSTwenty-nine studies involving 3050 lesions were selected for the meta-analysis. The pooled sensitivity and specificity for CEUS diagnosing malignant breast lesions were 0.87 [95% confidence intervals (CI), 0.81-0.90] and 0.79 (95% CI, 0.73-0.84), respectively. The positive and negative likelihood ratios were 4.17 (95% CI, 3.21-5.42) and 0.17 (95% CI, 0.12-0.24), respectively. The summary diagnostic odds ratio of CEUS to differentiate benign and malignant breast lesions was 20.55 (95% CI, 14.11-29.93), and the Lambda of CEUS for detecting malignant breast lesions was 3.18 (95% CI, 2.71-3.64). Subgroup analyses showed that patients' age and contrast agents (Levovist, SonoVue, or other) might affect the diagnostic accuracy of CEUS used to differentiate benign and malignant breast lesions.CONCLUSIONSCEUS had a relatively high diagnostic accuracy to differentiate benign and malignant breast lesions. Moreover, the diagnostic value of CEUS in younger patients or those using SonoVue as contrast agents was higher than that in the corresponding subgroups.