Friday, October 3, 2014

Entamoeba histolytica Rapid Test Receives CE Mark

Alere Inc., a global leader in rapid diagnostics, announced today that the new E. HISTOLYTICA QUIK CHEK™ test, which identifies the Entamoeba histolytica parasite, has received CE Mark for sale in international markets outside of the United States. The test is developed and manufactured by TECHLAB® Inc.

Entamoeba histolytica is an intestinal parasite that infects an estimated 50 million people worldwide. Infected individuals can develop bloody diarrhea, colitis and liver abscesses, and up to 100,000 deaths from amebiasis are estimated annually.[1] E. histolytica disease has also been diagnosed in 12% of travellers returning from the developing world with acute diarrhea.[2]

"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.[3] 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 C. difficile-associated disease.

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."

  1. Buss, S. et al. (2008) Comparison of Two Immunoassays for Detection of Entamoeba histolytica. J. Clin. Micro. Vol 46, No. 8, pp.2778-2779.
  2. Freedman, D.O. et al. (2006) Spectrum of Disease and Relation to Place of Exposure among Ill Returned Travellers. N. Engl. J. Med. 354;2.
  3. Guerrant. G.L. et al (2011) Tropical Infectious Diseases: Principles, Pathogens and Practice. Vol 1. Enteric Amebiasis. Chapter 67:pp.685-702.

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