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Development and validation of a point of care system for measuring cardiac troponin levels in blood

Abstract

Cardiovascular diseases occupy the first place in the mortality ranking in Brazil and in the world. It is in this scenario that the dosage of troponin in patients seeking medical care for chest pain (angina) becomes paramount. The immediate measurement of the level of cardiac troponin in the blood, together with the electrocardiogram and the medical interview, can help in the early diagnosis of infarction, which can prevent the patient from developing heart failure. Thus, the most promising solution to reduce cases of heart failure and deaths from infarction is the measurement of cardiac troponin level in a short time. The present project proposes the development and improvement of biosensor scale production processes for use in a point of care device for rapid measurement of troponin in hospital emergency, which may in the future be applied to the measurement of other biomarkers to also assist in the diagnosis of other pathologies. . The Cor.Sync Point of Care device, developed in 2019 by the company Cor.Sync, is a benchtop equipment for in-vitro diagnostics intended for direct use on the triage table or hospital emergency, requiring no controlled environment or laboratory technicians. The company filed a trademark application and an invention patent application BR102020016781, which protects the method, device and sensors developed by its founding partners. Its operation is based on the surface plasmon resonance (SPR) methodology of gold nanofilm, when this phenomenon is altered through the binding of a target antigen on the surface of the metallic sensor, which can be related to abnormal levels of such components. in the patient's whole blood. The sensor is supplied in a consumable cartridge, formed by a plastic encapsulation that protects the nanofilm and with an insertion point for whole blood samples by common syringes. A sensor is required for each test, which receives 30 µL of whole blood, conducted through channels to the surface of the sensor. The consumable is then inserted into the equipment, which performs a differential measurement of the antigen-antibody reaction versus measurement of its bulk (whole blood without reaction), through an engineering composed of arrays of laser emitters and optical detectors, developed by the Cor.Sync team. (AU)

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