Quantra™ should be considered a tool for two-grade scale mammographic breast density classification

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Abstract
Objective:To assess the agreement between QuantraTM (Hologic Inc.) and BI-RADS® and the performance of QuantraTM at reproducing BI-RADS® mammographic breast density (MBD) assessment.Methods:MBD was performed using QuantraTM and BI-RADS®. BI-RADS® assessment was performed in two phases (1314 and 292 cases respectively). Kappa was used to assess inter-reader agreement and the agreement between QuantraTM and BI-RADS®, and Receiver Operating Characteristics was used to assess the performance of QuantraTM at reproducing BI-RADS® rating.Results:Agreement (Weighted Kappa) between BI-RADS® and QuantraTM in phase 1 was 0.75 (95%CI: 0.73 – 0.78) and 0.85 (95%CI: 0.80 – 0.90) on a four- and two-grade scales respectively. The corresponding agreement in phase 2 was 0.79 (95%CI: 0.75 – 0.84) and 0.84 (95%CI: 0.79 – 0.87) using the majority report. In phase 1, QuantraTM demonstrated 93.2% sensitivity and 86.1% specificity for BI-RADS® on a two-grade scale (1–2 vs 3–4). In phase 2, it demonstrated 91.3% sensitivity and 8...

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