International Journal of Drug Delivery Technology
Volume 16, Issue 16s, 2026

An Observational Study on the Diagnostic Accuracy of BI-RADS Classification Versus Histopathology findings in Palpable Breast Lumps

Swathi Sivakumar1*, Saravanan P.S2, Amit Kumar Rai3, Anisha A4

1Postgraduate, Department of General Surgery, Meenakshi Medical College Hospital & Research Institute, Kanchipuram, MAHER University, Chennai

2Professor and HOD, Department of General Surgery, Meenakshi Medical College Hospital & Research Institute, Kanchipuram, MAHER University, Chennai

3Assistant Professor Department of General Surgery, Meenakshi Medical College Hospital & Research Institute, Kanchipuram, MAHER University, Chennai

4Postgraduate, Department of General Surgery, Meenakshi Medical College Hospital & Research Institute, Kanchipuram, MAHER University, Chennai

*Correspondence: Dr. Swathi Sivakumar, Email: swathishy10@gmail.com

Received: 12th Dec, 2025; Revised: 12th Feb 2026; Accepted: 13th Feb, 2026; Available Online: 10th March, 2026


ABSTRACT

Background: Clinically palpable breast lumps are a common presentation and require accurate evaluation to differentiate benign from malignant lesions. The BI-RADS system provides standardized imaging classification, but its diagnostic accuracy needs correlation with histopathology.

Aim: To evaluate the diagnostic accuracy of BI-RADS classification in correlation with histopathological findings in palpable breast lumps.

Materials and Methods: This hospital-based observational study was conducted at Meenakshi Medical College Hospital, Kanchipuram, over one year. A total of 50 patients with palpable breast lumps were included. All patients underwent clinical examination, imaging using ultrasonography and/or mammography, and BI-RADS categorization. Histopathological examination was considered the gold standard. Sensitivity, specificity, PPV, NPV, and accuracy were calculated. A p value < 0.05 was considered significant.

Results: The mean age was 42.6 ± 11.8 years, with most patients in the 31–45 years group (36%). Histopathology showed 60% benign and 40% malignant lesions. A significant correlation was found between BI-RADS and histopathology (p = 0.001). BI-RADS showed 90% sensitivity, 80% specificity, and 84% accuracy. Malignancy increased with age (p = 0.028).

Conclusion: BI-RADS classification is a reliable and effective diagnostic tool for evaluating palpable breast lumps. Its strong correlation with histopathological findings supports its role in early detection, risk stratification, and guiding management decisions.

Keywords: BI-RADS, breast lump, histopathology, diagnostic accuracy, breast cancer.

How to cite this article: Sivakumar S, P.S S, Rai AK, A A. An Observational Study on the Diagnostic Accuracy of BI-RADS Classification Versus Histopathology findings in Palpable Breast Lumps. Int J Drug Deliv Technol. 2026;16(16s): 592-596. DOI: 10.25258/ijddt.16.16s.64

Source of support: Nil.

Conflict of interest: None