HIV Diagnostics: From Serologic Assays to Molecular POC Testing for Epidemic Control
This comprehensive review traces the evolution of HIV diagnostics from early serologic assays through current high-sensitivity molecular methods, including point-of-care nucleic acid testing. The authors describe how a tiered laboratory network combining conventional and POC platforms can expand coverage and reduce turnaround times in resource-limited settings. Quality management systems and regulatory alignment are identified as critical enablers for achieving global epidemic control targets.
The original study
Diagnosis of Human Immunodeficiency Virus Infection.
- Authors
- Parekh BS, Ou CY, Fonjungo PN, Kalou MB, Rottinghaus E, Puren A, et al.
- Journal
- Clinical microbiology reviews
- Type
- Historical Article, Journal Article, Research Support, U.S. Gov't, P.H.S., Review
- PMID
- 30487166
Original abstract
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.