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Cryptosporidiosis is a leading cause of persistent diarrhea in developing and developed countries. Cryptosporidiosis is caused by gastrointestinal infection with the protozoan parasite Cryptosporidium spp. Symptoms of cryptosporidiosis include watery diarrhea, stomach cramps, weight loss, nausea, and fever. This highly pathogenic parasite is transmitted in contaminated water and by the faecal-oral route. Prevalence rates of Cryptosporidiosis in a symptomatic population in developed countries exceed 2-3% and serological surveys indicate that the vast majority in the US has been exposed to this pathogen. In addition, this opportunistic pathogen is also highly prevalent in immuno-compromised patients (e.g., 10-40% in HIV patients).

Diagnosis of cryptosporidiosis is routinely performed by microscopic analysis of stool samples using organic dyes. Because detection of Cryptosporidium can be difficult, patients may be asked to submit several stool samples over several days. DNA amplification techniques such as PCR or RT-PCR have been also reported, however, such tests are not commercially available yet.

Savyon’s CoproELISA Cryptosporidium is a newly introduced ELISA-based test for qualitative detection of cryptosporidial antigens in fecal specimens. Combination of both polyclonal and monoclonal antibodies against oocysts of cryptosporidium spp. yields high accuracy with both fresh and formalin/SAF preserved samples