Increasing Diagnostic Uncertainties in Children With In Utero HIV Infection

Millar, Jane; Mvo, Zodumo; Bengu, Nomonde; Fillis, Rowena; Sprenger, Ken; Matthews, Philippa C.; Archary, Moherndran; Ndung’u, Thumbi; Adland, Emily; Puertas, María C.; Martínez-Picado, Javier; Goulder, Philip

doi:10.1097/inf.0000000000002315

Cited by 5 publications

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“…The finding here that only children with low initial HIV DNA loads had undetectable total HIV DNA on the RUO PoC test undertaken after a mean of 24 to 25 months of aviremia is consistent with previous studies showing time to undetectability is longer if the starting HIV DNA load is higher. [ 9 , 14 ] However, an alternative hypothesis for future studies would be that PoC testing at 2 years, for example, might distinguish children with high potential for cure/remission via additional interventions such as broadly neutralizing antibody versus those whose viral reservoir is more refractory to cART. [ 15 , 16 ]…”

Section: Discussionmentioning

confidence: 99%

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Next-generation point-of-care testing in pediatric human immunodeficiency virus infection facilitates diagnosis and monitoring of treatment

et al. 2022

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Point-of-care (PoC) testing facilitates early infant diagnosis (EID) and treatment initiation, which improves outcome. We present a field evaluation of a new PoC test (Cepheid Xpert® HIV-1 Qual XC RUO) to determine whether this test improves EID and assists the management of children living with human immunodeficiency virus (HIV) infection.We compared 2 PoC tests with the standard-of-care (SoC) test used to detect HIV infection from dry blood spots in newborn infants at high risk of in utero infection. We also evaluated the ability of the PoC tests to detect HIV total nucleic acid (TNA) in children living with HIV infection who had maintained undetectable plasma viremia following very early combination antiretroviral therapy (cART) initiation.Qualitative (Qual) detection of HIV using the Xpert® HIV-1 Qual XC RUO ("RUO") and Xpert® HIV-1 Qual ("Qual") PoC tests was compared in 224 infants with the SoC DBS Roche COBAS® HIV-1/HIV-2 qualitative test. The same 2 PoC tests were also evaluated in 35 older children who had initiated cART before 21 days of age and maintained undetectable plasma viremia for a mean of 25 months.No discrepancies were observed in detection of HIV infection via the 2 PoC tests or the SoC test in the 224 neonates studied, but only 95% of the SoC test results were generated compared with 100% of the PoC test results (P = .0009). The cycle threshold values for the research use only (RUO) assay were the lowest of the 3 assays (P < .0001 in each case). In 6 of the 35 early-treated aviremic children, HIV TNA was detected by RUO but not Qual.The RUO assay outperforms Qual in detecting HIV-1 infection. RUO would therefore potentially improve EID and assist in identifying cART-adherent early-treated children with the lowest HIV TNA levels and the highest HIV cure potential. Abbreviations: ART = combination antiretroviral therapy, Ct = cycle threshold, DBS = dry blood spot, EID = early infant diagnosis, HIV = human immunodeficiency virus, PBMC = peripheral blood mononuclear cell, PoC = point-of-care, Qual = qualitative, RUO = research use only, SoC = standard of care, TNA = total nucleic acid.

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