Abstract
IntroductionViral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis is performed using nucleic‐acid testing in children under 18 months. Resource‐limited health systems face severe challenges to scale‐up both viral load and early infant diagnosis to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an early infant diagnosis assay in children younger than 18 months.MethodsThis study was an observational, prospective study, including children between one and 18 months of age who were born to HIV‐positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and VL testing using the Roche CAP/CTM HIV‐1 Qualitative v2 and Roche CAP/CTM HIV‐1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard.ResultsA total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994.ConclusionsThe comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional early infant diagnosis testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.
Highlights
Viral load testing is essential to manage HIV disease, especially in infants and children
Infants excluded from the study were those less than one month and older than 18 months of age or with low quality specimen, according to the rejection criteria used for HIV early infant diagnosis (EID) routine testing in Mozambique
The sensitivity and specificity of the viral load assay to correctly diagnose HIV infection compared to the EID assay was 100.0% and 99.9% respectively (Table 2)
Summary
Viral load testing is essential to manage HIV disease, especially in infants and children. Infant diagnosis is performed using nucleic-acid testing in children under 18 months. We evaluated the performance of viral load testing to serve as an early infant diagnosis assay in children younger than 18 months. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional early infant diagnosis testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management. In Mozambique, of the estimated nearly 130,000 HIV-exposed infants, approximately 63% received an EID test in 2018.
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