This work aimed to assess the diagnostic performance of strain elastography (elasticity score) and its accuracy for breast BI-RADS category 4 lesions. Online databases including Cochrane Library, Embase, PubMed, and Web of Science were searched for eligible articles published prior to March 10, 2022. The pooled effect indicators including sensitivity, specificity, positive and negative likelihood ratios (PLR, NLR), the area under the summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR) were utilised to assess the strain elastography's performance in diagnosing BI-RADS category 4 lesions. Subgroup analyses and meta-regressions were used to explore the potential sources of heterogeneity, and the Deeks' funnel plot asymmetry test was used to detect any publication bias. The literature search yielded 11 studies involving 5028 BI-RADS category 4 lesions (including 1809 malignant lesions). The recruited lesions were all from Asian females. The pooled sensitivity, specificity, PLR, NLR, and DOR with the 95% confidence intervals were 0.68 (0.66-0.71), 0.83 (0.82-0.85), 3.36 (2.45-4.60), 0.32 (0.21-0.49), and 12.11 (7.46-19.65), respectively. The area under the SROC curve was 0.85. No significant publication bias was detected. Taken together, strain elastography had suboptimal sensitivity but desirable specificity for the accurate diagnosis of BI-RADS category 4 lesions among Asian females, which can help avoid unnecessary biopsies and reduce patient anxiety. Key Words: BI-RADS category 4 lesions, Strain elastography, Meta-analysis.