Rapid Medical Diagnostics is proud to be part of the commercialization and rollout of urine based Bilharzia (Schistosoma) diagnostic test strips. Production of the rapid test strips is the final result of years of research and extremely hard work by several people and institutions.
Besides urine and stool microscopy, this is the only test that can truly detect active infections. The test demonstrates parasite antigen in patient urine and although it was originally designed for the detection of S.mansoni, it can detect S.haematobium in mid to high level infestations. The antigen detected is Circulating Cathodic Antigen (CCA), secreted by the adult Bilharzia worm. Although there are serum antibody tests on the market, they cannot reliably differentiate between active and non-active infections. For endemic studies, a single CCA urine test demonstrates closely the true prevalence predicted by models based on multiple egg count determinations.
Since 1978, research work at the Dept. of Parasitology of the LUMC, in Leiden, The Netherlands, by prof. Deelder and colleagues, has focused on improving diagnosis of schistosomiasis using assays detecting circulating antigens, CCA as well as CAA (Circulating Anodic Antigen). After first using polyclonal antibodies, in the 80-ies specific monoclonal antibodies have been developed at the Dept. of Parasitology, resulting in widely used and highly optimized ELISA systems. Since early 2000, the ELISA’s have been further refined and transformed into a monoclonal antibody based lateral flow assay (by Dr. van Dam and colleagues), by which CCA could be detected in a single drop of urine in a highly sensitive and specific way. This latter assay, which was mainly used for research purposes, is now the basis for the current POC-CCA assay.
Rapid Medical Diagnostics was originally registered for the marketing and sales of test strips for the detection of Bilharzia (Schistosoma) antigen in urine. Rapid Medical Diagnostics has subsequently acquired worldwide exclusivity rights for the specific monoclonal antibodies and is now managing all commercial production. Rapid Medical Diagnostics outsources production to third party producers with the necessary expertise and production facilities and if required, ISO accreditation.