Abstract
The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX p24 Antigen POC test in Mozambique. 879 HIV-exposed infants under 18 months of age were enrolled consecutively at three primary healthcare clinics (PHC). Lancet heel-drawn blood was tested on-site by nurses using a prototype POC test for HIV Gag p24 antigen detection. Results of POC testing were compared to laboratory-based nucleic acid testing on dried blood spots. A comparison of the effect of sensitivity and timely test results return on successful diagnosis by POC and laboratory-based platforms was also calculated. The sensitivity and specificity of the LYNX p24 Ag test were 71.9%; (95% confidence interval [CI]: 58.5–83.0%) and 99.6% (95% CI: 98.9–99.9%), respectively. The predictive value of positive and negative tests were 93.2% (95% CI: 81.3–98.6%) and 97.9% (95% CI: 96.8–98.8%), respectively. Overall agreement was high (Cohen Kappa = 0.80; 95% CI: 0.71–0.89). Despite its lower sensitivity, the POC test had the potential to provide test results to up to 81% more patients compared to the laboratory-based test. This prototype POC p24 assay was feasible for use in PHCs but demonstrated low sensitivity for HIV detection. POC EID technologies that perform below standard recommendations may still be valuable diagnostic tools in settings with inefficient EID networks.
Highlights
Children living with HIV continue to experience persistent treatment gaps with a coverage that is two-third of that of pregnant women (51% versus 80%) in 2015.[1]
Several operational innovations have been made to improve the efficiency of this conventional system, the time required to transport samples, conduct the test and communicate results back to health facilities and patients remain long in many settings, resulting in high loss-to-follow-up and low antiretroviral treatment (ART) initiation rates [5]
The proportion of infants who tested positive for HIV with the laboratory-based early infant diagnosis (EID) test was 6.7% (n = 57) and this increased with age at testing: 2.7%, 9.6%, 10.7%, 14.3% and 46.2% in the 1–2 months, 2–3 months, 3–6 months, 6–9 months and >9 months age groups, respectively (p
Summary
Children living with HIV continue to experience persistent treatment gaps with a coverage that is two-third of that of pregnant women (51% versus 80%) in 2015.[1]. The World Health Organization (WHO) recommends testing of exposed infants by six weeks of life, or at the earliest opportunity thereafter, and immediate ART initiation for all HIV-. In 21 priority African countries, only 51% of HIV-exposed infants received HIV virological testing within the first two months of life in 2015 [1]. Several operational innovations have been made to improve the efficiency of this conventional system, the time required to transport samples, conduct the test and communicate results back to health facilities and patients remain long in many settings, resulting in high loss-to-follow-up and low ART initiation rates [5]. In Mozambique, an estimated 62% of HIV-exposed infants received EID results more than 1 month after sample collection in 2014, and this likely contributes to increased loss to follow-up, morbidity and mortality
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