Abstract

Home diagnostic testing is becoming part of the modern medical landscape, but many ethical and policy questions remain unresolved. Most of them first surfaced during the long regulatory deliberations over the home HIV test, the first home test for a contagious illness sold in the United States. Between 1989 and 2012, federal regulators and their consultants debated the ideal metrics for such a test, its benefits, and its potential harms for both individuals and communities. Ultimately, two iterations of the home HIV test were marketed in the United States; neither one of them changed the course of the national HIV epidemic, as hoped. This failure has powerful implications for home testing for other contagious diseases.