Evaluation of a novel rapid diagnostic test for Schistosoma haematobium based on the detection of human immunoglobulins bound to filtered Schistosoma haematobium eggs.

To determine whether the detection of human IgG bound to Schistosoma haematobium eggs from filtered urine could be used as a rapid diagnostic test (RDT-Sh). We filtered 160 urine samples from children in the Kwale District of Kenya to isolate S. haematobium eggs and used anti-human IgG antibody conjugated to horseradish peroxidase to bind to the human IgG attached to the eggs. We then added 3,3'5,5'-tetramethylbenzidine base (TMB), which turns blue in the presence of horseradish peroxidase to detect the S. haematobium eggs. The RDT-Sh was compared in a blinded manner to urine microscopy. The RDT-Sh was positive in 89% of urine samples containing >1 egg/10 ml (58/65 samples) and 97% of urine samples containing >11 eggs/10 ml urine (35/36 samples) seen by microscopy. The RDT-Sh was negative 79% of the time when no eggs were seen on urine microscopy, but because up to three times more urine was used for the RDT-Sh, there were likely cases in which eggs were on the RDT-Sh filter but not detected by microscopy. We used latent class analysis incorporating urine microscopy, haematuria, proteinuria and RDT-Sh results to determine an overall 97% sensitivity and 78% specificity for RDT-Sh, 96% and 81% for urine microscopy, 71% and 98% for microscopic haematuria and 46% and 89% for proteinuria, respectively. The RDT-Sh is quick, inexpensive and easy to perform in the field for the diagnosis of S. haematobium.