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iardia lamblia (G. lamblia) is one of the most common intestinal parasites in the world, with an estimated 3 million infections per year in humans, contributing to diarrhea and nutritional deficiencies in children in developing regions. G. lamblia is a flagellated protozoan parasite that colonizes and reproduces in the small intestine, causing Giardiasis.  Giardiasis does not spread via the bloodstream, nor does it spread to other parts of the gastro-intestinal tract, but remains confined to the lumen of the small intestine. Giardia trophozoites absorb their nutrients from the lumen of the small intestine, and are anaerobes. Giardia infection can occur through ingestion of dormant cysts in contaminated water, food, or by the faecal-oral route. In humans, infection is symptomatic only about 50% of the cases. Symptoms of infection include (in order of frequency) diarrhea, malaise, excessive gas, steatorrhoea, epigastric pain, bloating, nausea, diminished interest in food, possible (but rare) vomiting which is often violent, and weight loss. People with recurring Giardia infections, particularly those with a lack of IgA, may develop chronic disease Giardia infection in humans is frequently misdiagnosed. Accurate diagnosis requires an antigen test or, if unavailable, an ova and parasite (O&P) examination of stool. Multiple stool examinations are recommended since the cysts and trophozoites are not shed consistently. Giardia infection is conventionally treated with metronidazole, tinidazole or nitazoxanide.

Cryptosporidiosis is a self-limited diarrheal disease that occurs in the community setting but can be chronic and potentially serious in immunocompromised patients. 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 symptomatic population at 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 such as Ziehl-Neelsen stain or fast acid stain, or by immuno-staining by direct fluorescent antibody [DFA]. Because detection of Cryptosporidium can be difficult, patients may be asked to submit several stool samples over several days. Several ELISA tests are also available for specific detection of oocyst antigens. DNA amplification techniques such as PCR or RT-PCR have been also reported, however, such tests are not commercially available yet. Nitazoxanide has been FDA-approved for treatment of diarrhea caused by Cryptosporidium in Immunocompetent patients.

Savyon’s CoproELISA Giardia/Cryptosporidium test is an Enzyme-Linked Immunosorbent Assay (ELISA) for detection of Giardia lamblia (G. lamblia) and Cryptosporidium antigens in human fecal specimens collected from patients with gastrointestinal symptoms. The test can be used for fecal specimens submitted for routine clinical testing from adults or children.