The diagnostic performance of ultrasonic S-Detect technology in the diagnosis of BI-RADS-4 breast nodules smaller and larger than 20 mm

Abstract Background: We aimed to explore the value of ultrasonic S-Detect in the differential diagnosis of Breast Imaging-Reporting and Data System (BI-RADS) 4 breast nodules smaller and larger than 20 mm. Methods: Between November 2020 and November 2022, a total of 382 breast nodules in 312 patients were classified as BI-RADS-4 by conventional ultrasound. Using pathology results as the gold standard, we applied receiver operator characteristics (ROC), sensitivity (SE), specificity (SP), accuracy (ACC), positive predictive value (PPV), and negative predictive value (NPV) to analyze the diagnostic value of BI-RADS, S-Detect, and the two techniques in combination (Co-Detect) in the diagnosis of BI-RADS 4 breast nodules smaller and larger than 20 mm. Results: There were 382 BI-RADS-4 nodules, of which 151 were pathologically confirmed as malignant, and 231 as benign. In lesions ≤ 20 mm, the SE, SP, ACC, PPV, NPV, area under the curve (AUC) of the BI-RADS group were 77.27%, 89.73%, 85.71%, 78.16%, 89.25%, 0.835, respectively. SE, SP, ACC, PPV, NPV, AUC of the S-Detect group were 95.05%, 78.92%, 83.15%, 67.50%, 95.42%, 0.855, respectively. SE, SP, ACC, PPV, NPV, AUC of the Co-Detect group were 89.77%, 93.51%, 92.31%, 86.81%, 95.05%, 0.916, respectively. The difference of SE, ACC, NPV, AUC between the BI-RADS group and the Co-Detect group was statistically significant (P 20 mm, SE, SP, ACC, PPV, NPV, AUC of the BI-RADS group were 88.99%, 89.13%, 88.99%, 91.80%, 85.42%, 0.890, respectively. SE, SP, ACC, PPV, NPV, AUC of the S-Detect group were 98.41%, 69.57%, 86.24%, 81.58%, 96.97%, 0.840, respectively. SE, SP, ACC, PPV, NPV, AUC of the Co-Detect group were 98.41%, 91.30%, 95.41%, 93.94%, 97.67%, 0.949 respectively. The difference in AUC between the BI-RADS group and the Co-Detect group was statistically significant (P < 0.05). Conclusions: S-Detect combined with BI-RADS is highly effective in the differential diagnosis of BI-RADS 4 breast nodules smaller and larger than 20 mm. However, being especially effective for lesions ≤ 20 mm, S-Detect combined with BI-RADS allows to reduce a number of unnecessary biopsies.