An Autoantibody Based Protein Microarray Blood Test to Enhance the Specificity of a Negative Screening Mammogram

• 作者: A. Bassein Kapov-Kagan A. Bitterman B. Piura G. Yahalom I. Novikov L. Strauss M. Rosenberg M. T. Sandri P. Engelman S. Iacobelli T. B. Bevers T. M. Allweis Z. Malyutin
• 来源期刊: 乳腺癌(英文)
• 学科: 医学
• 关键词: AUTOANTIBODIES Breast Cancer Diagnostic SCREENING
• 年，卷（期）: rxayw_2015,（1）
• 页码范围: 22-38
• 页数: 17页
• 分类号: R73

摘要

Background: Current screening mammography for breast cancer is associated with misdiagnosis in as many as 30% of cases. Objectives: To develop and clinically evaluate a unique autoantibody based protein microarray blood test to improve the accuracy of breast cancer screening. Materials and Methods: A microarray was constructed from commercial antigens and antigens selected from screened cDNA libraries of breast cancer tissue samples. A training set containing 439 healthy controls and 276 biopsy proven breast cancer cases was used to establish a set of separating models between the two groups. These models were used to assign a diagnosis to 285 blind samples from 120 breast cancer patients and 165 healthy controls. Results: The test identified 82 of the 120 breast cancer patients and 160 of the 165 healthy controls. These results can be translated into a sensitivity of 68.3% [CI: 59% -77%] and a specificity of 97% [CI: 93% -99%], with a PPV for this validation set of 94.3% (CI: 87.10% -98.11%), NPV of 80.81% [CI: 74.62% -86.05%] and an AUC of 89.2% [CI: 78% -87%]. Conclusions: The protein microarray can be utilized to reduce the false negative rate of routine screening mammography. Women with a negative mammography and a negative blood test can be reassured and encouraged to continue routine breast cancer screening. A positive test should alert the physician about the possible presence of a breast cancer not detected by routine screening mammography and drive to perform additional investigation, such as breast ultrasound and MRI.