HIV Testing in Blood Banks

Abstract

Infectious disease testing presents special challenges in the blood bank setting, all of which are heightened with an agent as clinically serious and as politically and emotionally charged as the human immunodeficiency virus (HIV). Technical performance requirements for assays used in blood banks are particularly stringent, with maximum sensitivity critical to protect recipients; and high specificity is vital to prevent inaccurate notification and deferral of blood donors, high rates of indeterminate rcuÓb/ity, and excessive wastage of blood and its derivatives. Because approximately 12 million blood donations are screened annually in the United States for each of seven infectious disease markers, issues such as automated sample handling, rapid and high through-put instrumentation, and data transfer-computer interfacing are major considerations. The performance of infectious disease testing in blood banks is closely monitored by the U.S. Food and Drug Administration (FDA), which has imposed increasingly stringent standards of “good manufacturing practices,” originally developed for pharmaceutical companies.^1,2 As a result, levels of training, procedural controls, documentation, and quality assurance are mandated that may not be generally required in other HIV testing settings.