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Objective:The automated breast ultrasound system (ABUS) is a potential method for breast cancer detection;however,its diagnostic performance remains unclear.We conducted a hospital-based multicenter diagnostic study to evaluate the clinical performance of the ABUS for breast cancer detection by comparing it to handheld ultrasound (HHHUS) and mammography (MG).Methods:Eligible participants underwent HHUS and ABUS testing;women aged 40-69 years additionally underwent MG.Images were interpreted using the Breast Imaging Reporting and Data System (BI-RADS).Women in the BI-RADS categories 1-2 were considered negative.Women classified as BI-RADS 3 underwent magnetic resonance imaging to distinguish true-and false-negative results.Core aspiration or surgical biopsy was performed in women classified as BI-RADS 4-5,followed by a pathological diagnosis.Kappa values and agreement rates were calculated between ABUS,HHUS and MG.Results:A total of 1,973 women were included in the final analysis.Of these,1,353 (68.6％) and 620 (31.4％) were classified as BI-RADS categories 1-3 and 4-5,respectively.In the older age group,the agreement rate and Kappa value between the ABUS and HHUS were 94.0％ and 0.860 (P＜0.001),respectively;they were 89.2％ and 0.735 (P＜0.001) between the ABUS and MG,respectively.Regarding consistency between imaging and pathology results,78.6％ of women classified as BI-RADS 4-5 based on the ABUS were diagnosed with precancerous lesions or cancer;which was 7.2％ higher than that of women based on HHUS.For BI-RADS 1-2,the false-negative rates of the ABUS and HHUS were almost identical and were much lower than those of MG.Conclusions:We observed a good diagnostic reliability for the ABUS.Considering its performance for breast cancer detection in women with high-density breasts and its lower operator dependence,the ABUS is a promising option for breast cancer detection in China.