Clinical consequences of using an indeterminate range for early infant diagnosis of HIV: A decision model
Journal of Acquired Immune Deficiency Syndromes Oct 23, 2019
Salvatore P, et al. - Given the World Health Organization recommendation for confirmatory testing for all infants initiating antiretroviral therapy (ART) in order to minimize false-positive diagnoses of HIV in exposed infants, researchers examined if semi-quantitative cycle thresholds (Cts) that identify positive results most likely to be false-positive may aid in clinical decisions in settings where confirmatory testing is not feasible or intermittently performed. For infants with weakly positive (“indeterminate”) results, a decision analysis model of HIV-exposed infants in sub-Saharan Africa was generated to determine the clinical consequences of deferring ART. The degree to which “indeterminate” results may decrease the number of infants commencing ART unnecessarily was determined while missing a small number of HIV-infected infants. The analysis revealed that the benefits of classifying weakly positive results as “indeterminate” may outweigh the risks when it is implemented in settings where confirmatory testing is not universal. Accordingly, a recommendation by the World Health Organization has been made to consider Ct values ≥ 33 indeterminate for infant HIV diagnosis.
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