Tryptase is one of the World Health Association criteria that is used for making a diagnosis of systemic mastocytosis, and with today’s clearance, laboratories throughout the U.S. can now offer tryptase testing to their customers on fully automated CLIA Moderate Complexity instruments
LOS ANGELES, Calif. (July 17, 2012 )--Thermo Fisher Scientific Inc., the world leader in serving science, is featuring the Thermo Scientific ImmunoCAP Tryptase Assay at the 2012 annual conference of the American Association for Clinical Chemistry (AACC). ImmunoCAP Tryptase is the first commercially available assay in the U.S. for mast cell tryptase to be available on Clinical Laboratory Improvement Amendments (CLIA) Moderate Complexity fully automated laboratory instruments. ImmunoCAP Tryptase is cleared for use with the Phadia® 100, Phadia 250, and Phadia 1000 instruments and is being featured within Thermo Scientific booth #2215 during AACC, at the Los Angeles Convention Center from July 17-19.
ImmunoCAP Tryptase measures the level of tryptase in serum/plasma. Human tryptase is present in mast cells, and serum/plasma basal levels of tryptase give an indication of number of mast cells. Elevated basal levels of tryptase are an indicator of systemic mastocytosis.
Systemic mastocytosis is a severe chronic disease with an increased number of mast cells in the skin and other tissues and organs. It is not possible to diagnose systemic mastocytosis based solely on physical examination. Having received 510(k) clearance from the U.S. Food and Drug Administration in February, the ImmunoCAP Tryptase provides physicians with additional tools and clinical insight to make an accurate diagnosis.
“Tryptase is one of the World Health Association criteria that is used for making a diagnosis of systemic mastocytosis, and with today’s clearance, laboratories throughout the U.S. can now offer tryptase testing to their customers on fully automated CLIA Moderate Complexity instruments,” said Jean Forcione, president of Thermo Fisher’s immunodiagnostics business.
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