![]() To accelerate the attainment of this goal, UNAIDS set ambitious 90-90-90 targets to be achieved by 2020, with the first 90 defined as 90% of HIV-infected persons knowing their status, the second 90 defined as 90% of patients with a diagnosis of HIV infection receiving ART, and the third 90 defined as 90% of ART-treated patients having viral suppression ( 9, 10). However, at this rate, the decline will still fall short of the United Nations’ set target of <500,000 new infections globally by 2020 ( 8). HIV prevention and the use of ART have reduced new HIV infections by 14%, from 2.1 million in 2013 to 1.8 million in 2016 ( 3, 7). As part of the strategy to achieve an “AIDS-free generation” ( 4, 5), the 2016 World Health Organization (WHO) HIV treatment guidelines recommend that ART be initiated in all individuals living with HIV regardless of the clinical stage or CD4 cell count in order to preserve patients’ immune systems, control HIV replication, and reduce further transmission ( 6). The sub-Saharan Africa (SSA) region alone accounted for approximately 69.5% (25.5 million) of the global HIV infections, with only 54.1% (13.8 million) having access to antiretroviral (ARV) therapy (ART) ( 2, 3) to suppress viral replication, prevent opportunistic infections, and prolong the lives of people living with HIV/AIDS (PLHIV). The Joint United Nations Program on HIV/AIDS (UNAIDS) estimated that there were 36.7 million HIV-infected persons and 1.8 million new infections globally by the end of 2016 ( 1). Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control. ![]() In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission “hot spots,” thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy.
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