SchistoDiag - Performance of new and standard tests for Schistosoma haematobium diagnosis in elimination settings
Project Abstract
The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Thanks to intense schistosomiasis control efforts over the past decades, in many endemic regions only few people are infected and carry a mostly very light parasite load. These light intensity infections impose a challenge for accurate diagnosis. Accurate diagnosis, however, is highly important in elimination settings to follow prevalence thresholds indicating when to stop large-scale interventions, to implement targeted interventions such as test-and-treat or other surveillance-response strategies, to validate elimination and to implement post-elimination surveillance. We aim to assess the performance of eight standard and new diagnostic tests for the diagnosis of S. haematobium in an elimination setting.
After an initial screening of 1200 children, total of five urine samples will be collected from 250 schoolchildren and examined for S. haematobium infection using the standard urine filtration method and for haematuria with reagent strips. In addition, the fifth collected urine sample from each child will be examined with established and new molecular tests (qPCR, PeakPCR, Recombinase Polymerase Amplification Assay) and an antigen test (Up-Converting Phosphor-Lateral Flow Assay) using both fresh and frozen samples. One finger-prick blood will be collected to perform new antigen and antibody based rapid tests at the point of care (POC; POC-circulating anodic antigen (POC-CAA) and POC-immunochromatography test (POC-ICT)). The diagnostic accuracy (sensitivity, specificity) of each test will be determined in comparison with the combined results of five urine filtrations.
The results will show how accurately the tests perform when applied on fresh and frozen samples from individuals living in an elimination setting, and when performed by trained local technicians (and not the scientific inventors) under the same conditions in a laboratory in a programmatic setting (and not in the laboratory of the scientific inventor). The results will provide evidence on the sensitivity and specificity of each test when implemented in an elimination setting and provide important insights if the tests are suitable to serve the different purposes for accurate prevalence determination, test-and-treat or validation of schistosomiasis elimination and can be recommended by WHO in this regard. The results are hence of high importance for scientists, schistosomiasis elimination programme managers, and WHO.
