CE Marked Rapid Test for Entamoeba histolytica
The E. HISTOLYTICA QUIK CHEK™ from Alere Inc. is the first rapid test to distinguish between pathogenic and non-pathogenic Entamoeba species. The test is developed and manufactured by TECHLAB Inc. and has now received CE Mark for sale in international markets outside of the USA.
"Accurate diagnosis of E. histolytica is very difficult because it is identical in appearance to a non-pathogenic species, Entamoeba dispar" said Dr. James Cottam, Alere Global Product Manager for Gastro-Intestinal Disease. "Currently available tests and microscopy cannot differentiate between the two species, often resulting in inaccurate diagnosis and inappropriate treatment."
Invasive E. histolytica infections can be treated effectively with antibiotics, whereas E. dispar colonization does not require treatment. The current global antibiotic resistance crisis highlights the need for prudent antibiotic use. Inappropriate use of antibiotics can also result in adverse complications for patients, including associated disease.
Using a lateral flow immunoassay format, the E. HISTOLYTICA QUIK CHEK test targets an adhesin unique to E. histolytica and is therefore the first rapid test available that can distinguish between pathogenic E. histolytica and non-pathogenic E. dispar. The test can be used for quick and reliable diagnosis of amebiasis.
"Achieving CE Mark for the new E. histolytica test enhances Alere and TECHLAB’s position as market leaders for gastro-intestinal disease diagnostics and is a testament to our strong partnership with TECHLAB," said Dr. Cottam. "By improving the accuracy of diagnostics for this important parasite, the E. HISTOLYTICA QUIK CHEK promises to be a significant help to clinicians, improving diagnosis and treatment decisions.”
Product not available in US.
Date Published: December 1, 2014
Source article link: Alere, Inc. » company contact details
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