HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

Recent developments in HIV diagnostic testing technology are summarized, their implications for clinical management and public health are outlined, current systems of regulatory oversight for HIV testing in the USA are described, and alternatives that could expedite access to improved tests as they become available are proposed.

Abstract

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.