Background & objectives:Breast cancer being one of the most common malignant tumours among women, diagnostic modalities for early detection of the same become of paramount importance. In this context, the hand-held ultrasound (HHUS) and automated breast volume scanner (ABVS) could provide valuable information for clinicians to diagnose breast diseases. This study aimed to compare and evaluate the diagnostic performance of combined use of HHUS and ABVS for the differentiation of benign and malignant breast lesions.Methods:A total of 361 female patients, who underwent both HHUS and ABVS examinations were included in this study. ABVS and HHUS images were interpreted using the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS). The distributions of the BI-RADS categories and pathology results were shown as specific numbers. Kappa coefficients test (κ) was calculated to compare the diagnostic results amongst the ABVS, HHUS and ABVS combined with HHUS. The sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of the three diagnostic methods were calculated and their respective diagnostic performance was analyzed by receiver operator characteristic curve.Results:Of a total of 431 lesions, 153 (35.5%) were malignant and 278 (64.5%) were benign. With respect to the pathology results, the value of κ was 0.713 (P<0.001) for HHUS, κ=0.765 (P<0.001) for ABVS and κ=0.815 (P<0.001) for HHUS+ABVS. The sensitivity, specificity, accuracy, PPV and NPV for HHUS combined with ABVS were 96.08 (147/153), 88.49 (246/278), 91.18 (393/431), 82.12 (147/179) and 97.62 per cent (246/252) respectively. For HHUS, these were 90.20 (138/153), 84.17 (234/278), 86.31 (372/431), 75.82 (138/182) and 93.98 per cent (234/249) respectively; and for ABVS these were 92.16 (141/153), 87.05 (242/278), 88.86 (383/431), 79.66 (141/177) and 95.28 per cent (242/254), respectively. There was no significant difference amongst these three methods, but the diagnostic performance of HHUS combined with ABVS was better than, or at least equal to, that of HHUS or ABVS alone.Interpretation & conclusions:The results of this study suggest that ABVS is a promising and advantageous modality for breast cancer detection. Furthermore, the combination of HHUS and ABVS showed a more comparable diagnostic performance than HHUS or ABVS alone for distinguishing between benign and malignant breast lesions.