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Medical technology company Tecil has obtained EC approval for their chloride sweat test, ISEsweat, which is used to diagnose cystic fibrosis. This product is innovative due to the fact that, "compared to the high number of manipulation errors in using the classical method, it is able to safely and quickly determine the chloride concentration in micro-samples of sweat taken directly from the patient’s skin," explains General Manager Rosa Passarell.

Tecil’s new device was presented at the 34th International Conference of the European Cystic Fibrosis Society (ECFS) held from 8 to 11 June in Hamburg.

Cystic fibrosis is a serious hereditary disease caused by a protein defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The CFTR mutation disrupts electrolyte transport leading to increased levels of chloride in sweat. The gold standard for diagnosing this disease is the sweat test, a method that measures sweat chloride levels and was originally designed by Gibson and Cooke in 1959.

There are other systems that allow for on site sweat analysis, but they are indirect methods based on analyzing conductivity. The new device designed by Tecil analyzes chloride levels. The classical sweat test includes three phases: sweat stimulation through iontophoresis, sweat collection, and analysis of chloride ion levels. The Tecil scientific group carried out an R&D project that has developed an analyzer capable of measuring chloride levels in micro-samples of sweat. Technical Director Rafael Camero explains that "the classical sweat test requires a certain quantity of sweat for later biochemical analysis, which generates a high percentage of failed results due to manipulation difficulties.” He adds that, “when a possible positive is detected through neonatal screening, obtaining definitive results quickly reduces parents’ anxiety and can increase the sick child’s life expectancy or improve their quality of life.”

The new sweat test can be used in pediatric, pulmonological and gastroenterological clinical units as well as in the laboratory. Distribution of the new analysis system to end-users in Spain has already begun, including the Pediatric Service at Hospital Virgen de la Luz in Cuenca and laboratory group General lab-Labco, as well as national distributors.

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