Point of care testing of HIV in children younger than 18 months with three different HIV virological assays. Experience from a district hospital in a resource-limited setting

Abstract

Diagnosis of HIV in children younger than 18 months can be challenging in developing countries because requires the use of HIV virological tests. In this study we describe the experience with three commercial assays, HIV-1 DNA polymerase chain reaction (PCR) (Roche Amplicor 1.5) with dried blood spot, HIV-1 RNA PCR (Roche COBAS TaqMan) with plasma and reverse transcriptase activity assay (Cavidi Exavir Load 3) with plasma in a rural setting of India. Sensitivity and specificity were 98.1% (95% confidence interval [CI] 90-100) and 99.3% (95% CI 97.9-99.9) for the HIV-1 RNA PCR assay, 66.7% (95% CI 29.9-92.5) and 100% (95% CI 96.8-100) for the HIV-1 DNA PCR assay, and 100% (95% CI 48-100) and 98.7% (95% CI 92.8-100) for the reverse transcriptase activity assay respectively. The low sensitivity of the HIV-1 DNA PCR assay in this setting is worrisome and warrants further investigations.

Can HIV reverse transcriptase activity assay be a low-cost alternative for viral load monitoring in resource-limited settings?

“…To the best of our knowledge, this is the most thoroughly evaluated study of ExaVir Load V3 from India to date. Thus far, there have been three comparative studies from India that have been reported from the states of Andhra Pradesh (Anantpur), 37 Tamil Nadu (Chennai) 7 and New Delhi. 32 Iqbal et al 7 from Chennai cross-sectionally evaluated the ExaVir Load assay V1 and Roche Amplicor Monitor assay.…”

“…They found a good agreement between the two tests and a significant inverse correlation between ExaVir Load and CD4+ T-cell count. Alvarez-Uria et al 37 from Anantpur compared the accuracy of ExaVir V3 with Roche Cobas TaqMan HIV-1 test and Roche Amplicor HIV-1 DNA assay for early infant diagnosis. ExaVir performed well showing 100% sensitivity and 99% specificity, but no quantitative correlations were evaluated.…”

Predictors of Delayed Entry into Medical Care of Children Diagnosed with HIV Infection: Data from an HIV Cohort Study in India

“…To assess the entry into HIV care, we calculated the time period between the diagnosis of HIV and the first CD4+ lymphocyte count determination or ART initiation, whatever occurred first. In children aged <18 months, the HIV diagnosis was performed using polymerase chain reaction virological assays [ 13 , 14 ].…”