VIASURE Entamoeba histolytica Real Time PCR Detection Kit is designed for specific identification of Entamoeba histolytica in human stool samples from patients with signs and symptoms of Entamoeba histolytica infection.

This test is intended for use as an aid in the diagnosis of Entamoeba histolytica infection in humans in combination with clinical and epidemiological risk factors.

DNA is extracted from stool specimens, multiplied using Real Time amplification and detected using specific primers and a fluorescent reporter dye probe for Entamoeba histolytica.

The genus Entamoeba contains many species, six of which are found in the human intestinal tract (Entamoeba histolytica, Entamoeba dispar, Entamoeba moshkovskii, Entamoeba coli, Entamoeba hartmanni, and Entamoeba polecki).

The World Health Organization estimates that infection with Entamoeba histolytica is responsible for approximately 50 million cases of amoebiasis worldwide each year, resulting in up to 100,000 deaths. The disease is spread primarily by food or water contaminated with cysts but may also be transmitted from person to person by faecal-oral route. Clinical features of amoebiasis range from asymptomatic colonization (90% of the cases) to amoebic dysentery (stomach pain, nausea or vomiting and severe diarrhea with bloody and slimy stools, fever) and invasive extraintestinal disease, most commonly in the form of liver abscesses.

This pathogenic amoeba is morphologically indistinguishable in its cyst and trophozoite stages by microscopy from E. dispar and E. moshkovskii, which the ability to cause disease is unclear. Due to this gold standard method cannot differentiate these species; various approaches have been implemented as amplification of the small-subunit ribosomal RNA (rRNA) (18S rRNA) gene of E. histolytica by real time PCR assay.