Evaluating Field Performance of Highly Sensitive Malaria RDT: Detection of Infection Among Febrile Patients, Asymptomatic Pregnant Women and Household Contacts in Mpigi, Uganda
Abstract BackgroundWorld Health Organisation recommends that malaria case management be based on parasite-based diagnosis in all cases, but currently available tools for clinical use have limitations, including the inability to detect low-level infections. Currently, next-generation highly sensitive rapid diagnostic tests (hsRDT) for Plasmodium falciparum (Pf) are commercially available, but require field-based validation. This study evaluated the performance of the highly sensitive NxTek™ Eliminate Malaria Pf (NxTek) diagnostic test in health facilities and community settings in Mpigi district, Uganda in comparison to the conventional rapid diagnostic tests (cRDTs).MethodsBetween April and December 2019, symptomatic and asymptomatic participants were randomly enrolled from the Outpatient Department (OPD), Antenatal Care (ANC), and community settings. The participants were tested with both cRDTs and an hsRDT to detect Plasmodium falciparum HRP2 antigen and quality assured results with PCR as a reference. Geo-coded real time data were transmitted by health facility and community-based providers using a smartphone with custom designed software.ResultsAt the OPD, the parasite positivity rate was 13.3% for HS-RDT, compared to 6.4% with cRDT. The HS-RDT detected twice the number of positives compared to cRDT. At ANC, 11% (384/3,490) of the pregnant women were malaria parasite positive. HS-RDT detected more positive cases (10.4%) than cRDT (7.0%). At the community setting, 79.7% (2,397/3,009) of the under-five age group were positive for malaria parasites. Index clients in households resulted in a detection of 21.1% (1,877) asymptomatic positive especially among school going children. Health workers were able to learn how to effectively perform the HS-RDT, from a one-day training session. The additional support supervision was provided for VHTs to enable all to transmit results through the android phones. ConclusionUse of HS-RDTs increased case findings of low parasite density infections compared to cRDTs in study populations and provides the opportunity to eliminate malaria reservoirs through treatments. There were minimal additional training requirements when the HS-RDT kits were introduced. The observed increased positivity rates among school-age children call for integrating targeted interventions into school health programs.