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Clin Microbiol Rev. 2018 Nov 28;32(1). pii: e00064-18. doi: 10.1128/CMR.00064-18. Print 2019 Jan.

Diagnosis of Human Immunodeficiency Virus Infection.

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International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
National Institute for Communicable Diseases/NHLS, Johannesburg, South Africa.
Division of Virology, School of Pathology, University of the Witwatersrand Medical School, Johannesburg, South Africa.
Africa Centres for Disease Control and Prevention, African Union, Addis Ababa, Ethiopia


SUMMARYHIV 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.


CD4; HIV incidence; HIV rapid tests; dried blood spots; drug resistance; early infant diagnosis; enzyme immunoassay; point-of-care testing; quality assurance; viral load

[Available on 2019-11-28]

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