First evaluation of the diagnostic accuracy of an automated 3D ultrasound system in a breast screening setting.

BACKGROUND/AIM: Automated ultrasound examination of suspicious findings can reduce the physician's workload in screening mammography. The present study examines the diagnostic accuracy of this method in comparison to mammography as the reference standard for the first time. PATIENTS AND METHODS: A total of 304 patients underwent automated 3D ultrasound examination after screening mammography. Mammograms and ultrasound images were assessed by independent examiners, and sensitivity, specificity and the degree of agreement between both methods were calculated. RESULTS: The degree of agreement was moderate (Cohen's κ=0.130 for all and 0.153 for positive/negative ratings), mainly owing to a high percentage of false-positive ultrasound results. However, the results of sonographical re-examination of suspicious mammograms were favorable. The only two undetected proven malignant lesions were microcalcified, and in three more cases with disagreement, the ultrasound diagnosis was correct. CONCLUSION: Automated 3D ultrasound imaging appears to be on a par with hand-held ultrasound in terms of diagnostic quality.