The decision to perform surgery in patients with a breast mass usually is made on the basis of combined diagnostic information, with fine-needle aspiration cytologic examination (FNAC) playing a central role. To determine and compare the quality of FNAC of the breast, a search was performed of the English literature for articles with quantitative information about their results. Twenty-nine such articles, containing 31,340 aspirations, were identified and summarized. Required data were extracted from these articles. These numbers were analyzed with the use of a two-by-four contingency table to relate the FNAC result (definitely malignant, suspect, benign, or unsatisfactory cytologic material) with the final diagnosis (malignant or benign breast disease). Test characteristics such as sensitivity, specificity, and the likelihood ratios for the four different FNAC results were derived for each study and compared. There was a striking difference between studies with regard to the probability of a particular FNAC upshot (e.g., in patients with breast cancer, the chance of obtaining definitely malignant cytologic material ranged from 0.35 to 0.92), the sensitivity (range, 0.65 to 0.98), the specificity (range, 0.34 to 1.0), and likelihood ratios. In the opinion of the authors, it is virtually impossible to infer general test characteristics of FNAC of the breast from the medical literature because of differences in methods and different biases. At best, the maximum attainable performance of this test can be described. For the development of a policy for breast mass management, the local test characteristics of this highly operator-dependent test should be established.