Annually >40,000 Malawian babies are exposed to HIV, and >1800 get infected. Maternal antibodies limit the utility of HIV antibody testing in children <18 months, and HIV-DNA-PCR is preferred. However, HIV-PCR testing sites are few, PCR is expensive and PCR result turn-around-times (TAT) average 3 months leading to ~ 1/3rd of tested infants being lost to
follow-up. A point-of-care HIV Test (POCT) may improve testing uptake and infant retention.
This study aimed to identify an appropriate POCT for HIV diagnosis in children <18 months of age and to estimate its impact on infant diagnosis and linkage to HIV care.
We conducted mixed methods study in two hospitals in Southern Malawi and evaluated: (1) performance, TAT, usability, acceptability, cost and cost-effectiveness for XpertHIV and compared it with HIV-DNA-PCR, and (2) performance and accuracy of plasma IP-10 in screening for HIV diagnosis and treatment failure among children aged 0-14 years; and (3) explored the potential role of HIV-LAMP assay in the diagnosis of HIV.
XpertHIV had high sensitivity (97.8%) and specificity (98.1%). TAT was reduced from 24 days to 5.3 hours: 85% of the children-initiated ART on the day of testing. Compared with qPCR cost (66.66),XpertHIVwascheaperat42.34 per diagnostic test. With the difference in test costs, if XpertHIV is adopted nationwide for testing of 40,000 HIV exposed babies, Malawi could save ~USD2,193,538.88 annually.
XpertHIV was acceptable to care givers, parents, laboratory technologists and nurses.
Although IP-10 levels were higher in those with high viral load and under two years of age, it could not distinguish HIV from other infections. The HIV LAMP optimisation was unsuccessful.
XpertHIV, if deployed in Malawi, could improve the diagnosis of paediatric HIV and its treatment uptake, and reduce costs of early infant diagnosis (EID). IP-10 is not an accurate screening marker for HIV in children. Further studies are needed to evaluate whether HIV LAMP is a suitable test for EI
