HIV Diagnostic Testing Strategies and Performance

The global control of HIV relies on timely and accurate diagnosis to initiate treatment and reduce onward transmission. Diagnostic strategies span laboratory-based immunoassays, point-of-care rapid tests and nucleic acid amplification methods. First- and third-generation assays detect host antibodies with high specificity but may not capture early seroconversion, whereas fourth-generation antigen/antibody combination tests incorporate detection of p24 antigen to shorten the window period. Nucleic acid amplification tests (NATs) further improve acute infection detection by identifying viral RNA or proviral DNA. Performance metrics such as sensitivity, specificity, positive predictive value and negative predictive value vary with assay generation, sample type and stage of infection. In high-resource settings, algorithmic approaches may combine rapid POC screening with confirmatory laboratory assays and reflex NAT for ambiguous or seroconversion cases. In low-resource or community settings, POC tests facilitate decentralised screening, although they often sacrifice early detection for simplicity. Recent advances focus on optimising test algorithms, improving antigen detection thresholds and developing in-house NAT protocols for low-prevalence regions. These combined strategies have enhanced case finding, informed public health interventions and guided pre-exposure prophylaxis programmes, underscoring the global significance of diagnostic innovation.

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HIV Diagnostic Testing Strategies and Performance publication trend

The graph below shows the total number of articles in hiv diagnostic testing strategies and performance across all publications each year (not limited to Nature Index journals).

Technical terms

Sensitivity: The proportion of true positives correctly identified by a test.
Specificity: The proportion of true negatives correctly identified by a test.
Acute HIV infection: The early phase following HIV exposure before full antibody seroconversion, often detectable by p24 antigen or viral RNA.
Fourth-generation assay: A diagnostic test that simultaneously detects HIV antibodies and p24 antigen to shorten the window period.
Point-of-care (POC): Testing performed at or near the site of patient care with rapid turnaround.
Nucleic acid amplification test (NAT): A molecular assay that amplifies and detects viral RNA or DNA, enabling early infection diagnosis.
p24 antigen: A core protein of HIV, detectable in plasma during acute infection prior to antibody formation.

References

1. Evaluation of a point-of-care rapid HIV antibody test with insights into acute HIV symptomatology in a population with low prevalence. Journal of Clinical Microbiology (2024).
2. Establishment of qualitative human immunodeficiency virus type 1 nucleic acid amplification test as an adjunct confirmatory test in low-prevalence areas and small- and medium-sized diagnostic laboratories. Heliyon (2024).
3. Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection. Medical Microbiology and Immunology (2020).