In March 1985, the FDA made a landmark decision by approving blood tests for the detection of HIV, responding to the alarming rise in AIDS cases during the early 1980s. As the understanding of HIV/AIDS increased, so did the awareness of its transmission capabilities, especially through blood donations. Blood transfusions began to garner scrutiny after several documented cases showed that individuals had contracted HIV through contaminated blood. The approval of testing mechanisms marked a critical advancement in medical safety protocols and public health initiatives, especially for healthcare institutions involved in blood transfusions.

The approved tests utilized enzyme-linked immunosorbent assays (ELISA), which allowed for preliminary screening of donated blood for antibodies to HIV. A positive ELISA result was often followed by confirmatory tests such as Western blot analysis, ensuring a two-tiered approach to accurate diagnostics. This strategy significantly reduced the risk of future transfusion-related HIV infections. Blood banks and hospitals across the United States implemented these screening processes quickly, emphasizing the necessity to safeguard patients receiving blood products.

The FDA's decision not only transformed blood bank operations but also acted as a precursor to further developments in HIV testing and treatment protocols. The health crisis prompted a wave of community awareness campaigns, education about HIV transmission, and increased funding for research into HIV prevention and cure strategies. Moreover, the establishment of rigorous testing standards drew national and international attention to the need for similar measures globally, laying the groundwork for more comprehensive healthcare policies.