Trinity Biotech, a developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, has obtained CE Marking and has filed for FDA approval for its new point-of-care Uni-GoldTM Giardia Test.
Following the CE marking, the company will now be able to sell this product in European markets through its extensive distributor network in the region and other territories.
Giardiasis, which occurs most often in children and is common in day care centers, is caused by an enteric parasite Giardia lamblia that infects the colon of humans and animals, typically due to consuming of contaminated food and water containing the Giardia cyst.
Designed as a rapid (15 minutes) lateral flow immunoassay, the Trinity Biotech Uni-GoldTM Giardia Test detects the presence of Giardia lamblia antigen in fresh and preserved human stool specimens.
The company has also filed for FDA approval in the USA for which approval is expected to be granted in the first half of 2012.
The product was developed by a research team at Trinity’s San Diego facility and is the first of a new range of point-of-care tests to be successfully developed.