To assess the diagnostic efficiency and clinical application value of S-Detect in breast lesions.

A total of 378 patients with 390 breast lesions who underwent ultrasound and S-Detect examinations at the Ultrasound Department of the Center for Breast Diseases of Peking University Cancer Hospital (Beijing Cancer Hospital) from April to July 2019 were selected for this retrospective analysis. Taking histopathological diagnosis as the gold standard, the four-fold table method was used to calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of ultrasound and S-Detect for the diagnosis of benign and malignant breast lesions. The Kappa test was used to examine the consistency of the results of ultrasound and S-Detect with the pathological diagnosis. Hypothetical judgments were made on the lesions with an uncertain diagnosis by S-Detect, in which those judged as malignant and benign lesions were designated as S-Detect 1 and S-Detect 2, respectively, and the diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for S-Detect 1 and S-Detect 2 were calculated.

The pathological results showed that among the 390 lesions in the 378 patients, 260 were malignant lesions and 130 were benign lesions. The diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of S-Detect were 94.6%, 56.2%, 81.2%, 83.9%, and 81.8%, respectively; the corresponding values of ultrasound were 100.0%, 9.2%, 71.0%, 100.0%, and 69.7%. Kappa analysis showed that the consistency between S-Detect and pathological diagnosis results was better than that between ultrasound and pathological diagnosis results (Kappa value: 0.553 vs 0.119, P<0.05). Sixty-nine lesions with an uncertain diagnosis by S-Detect underwent hypothetical judgments. The results showed that the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for S-Detect 1 were 94.6%, 56.2%, 81.2%, 83.9%, and 81.8%, respectively; the corresponding values for S-Detect 2 were 79.6%, 79.2%, 88.5%, 66.0%, and 79.5%.

S-Detect technology has appreciated diagnostic value for breast lesions; especially for benign lesions, the diagnostic performance is better than that of ultrasound. However, there are some limitations in clinical application such as unclear judgment of some lesions. How to use S-Detect more appropriately in clinical setting requires more in-depth research to confirm.