SUMMARY HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. 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 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. 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. 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 the last few years, the use of HIV rapid testing has expanded worldwide in response to the call for universal access to prevention, care, and treatment by UNAIDS and the World Health Organization. HIV rapid testing is performed by people with varied skills in laboratory and nonlaboratory settings. Accurate HIV diagnostic testing is the first step to identifying infected persons for follow-up referral and care. However, there are several challenges related to test kit quality, test selection, testing algorithms, training, quality assurance (QA), quality of new lots, and postmarket performance. We highlight various issues that impact the quality of HIV rapid testing and provide solutions to monitor and improve test accuracy, especially in resource-limited settings. These include the use of validated kits, training with emphasis on QA, use of a standardized log book, dried-tube specimen-based proficiency testing, new kit lot verification, and postmarket surveillance. Systematic implementation of these tools should greatly enhance the quality of HIV rapid testing.

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Plasma levels of human immunodeficiency virus type 1 (HIV-1) RNA and markers of immune activation were compared among HIV-1-infected female sex workers (FSWs) with (n=112) and without (n=88) sexually transmitted diseases (STDs) in Abidjan, Côte d'Ivoire. After adjustment for CD4+ T cells, the median virus load was 2.5-fold higher among HIV-seropositive FSWs with STDs than among those without an STD (P=.053). Median virus load was higher for FSWs with a genital ulcer (P=.052) or gonorrhoea (P=.058) than for FSWs without any STD. Median levels of markers of immune activation (CD38 and HLA-DR on CD8+ T cells, soluble tumor necrosis factor-alpha receptor II, and beta(2)-microglobulin) tended to be elevated, albeit nonsignificantly, among FSWs in the STD group. These findings have important public health implications in elaborating strategies for decreasing disease progression and transmission of HIV among FSWs.