(1) Objective: To evaluate the diagnostic performance of prototype handheld ultrasound compared to automated breast ultrasound, according to the fifth edition of BI-RADS categorization, among females with positive lumps. (2) Methods: A total of 1004 lesions in 162 participants who underwent both prototype handheld ultrasound and automated breast ultrasound were included. Two radiologists and a sonographer independently evaluated the sonographic features of each lesion according to the fifth BI-RADS edition. The kappa coefficient (κ) was calculated for each BI-RADS descriptor and final assessment category. The cross-tabulation was performed to see whether there were differences between the ABUS and prototype HHUS results. Specificity and sensitivity were evaluated and compared using the McNamar test. (3) Results: ABUS and prototype HHUS observers found the same number of breast lesions in the 324 breasts of the 162 respondents. There was no significant difference in the mean lesion size, with a maximum mean length dimension of 0.48 ± 0.33 cm. The assessment of the lesion's shape, orientation, margin, echo pattern, posterior acoustic features, and calcification was obtained with good to excellent agreements between ABUS and prototype HHUS observers (κ = 0.70-1.0). There was absolutely no significant difference between ABUS and prototype HHUS in assessment of lesion except for lesion orientation p = 0.00. Diagnostic accuracy (99.8% and 97.7-98.9%), sensitivity (99.5% and 98.0-99.0%), specificity (99.8% and 99.6-99.8%), positive predictive value (98.1% and 90.3-96.2%), negative predictive value (90.0% and 84.4-88.7%), and areas under the curve (0.98 and 0.83-0.92; p < 0.05) were not significantly different between ABUS and prototype HHUS observers. (4) Conclusion: According to the fifth BI-RADS edition, automated breast ultrasound is not statistically significantly different from prototype handheld ultrasound with regard to interobserver variability and diagnostic performance.
Keywords: ABUS; BI-RADS; HHUS; breast cancer; prototype handheld ultrasound.