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

• Grant number: 20/05786-6
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: April 01, 2021
• End date: December 31, 2021
• Field of knowledge: Engineering - Biomedical Engineering - Medical Engineering
• Principal Investigator: Raul de Macedo Queixada
• Grantee: Raul de Macedo Queixada
• Company: Cor Sync Desenvolvimento de Sistemas Ltda
• CNAE: Serviços de engenharia
• City: São Paulo
• Pesquisadores principais: Paulo Henrique Garcia de Sá
• Associated researchers: Attilio Galhardo Pimpinato ; Edson Costa Santos ; Lucas Bóries Fachin ; Moisés Felipe Teixeira ; Roberta Mansini Cardoso
• Associated research grant(s): 22/08231-0 - Development and validation of a point of care system for measuring cardiac troponin levels in blood, AP.PIPE
• Associated scholarship(s): 21/04190-5 - Development and validation of a point of care device for measuring cardiac troponin levels in blood, BP.PIPE

Abstract

Myocardial infarction (MI) is one of the main causes of death in the world, along with the rest of the group of coronary artery diseases, reaching the number of 7.4 million in 2015. In 2018, 93,272 deaths by MI were registered in Brazil. Early diagnosis of MI is essential for the proper treatment of the patient and can reduce mortality. Today the diagnosis is made, in most cases, based on changes in the electrocardiogram (ECG), clinical history and, when available, laboratory examination. When an ST segment elevation is detected on the ECG, the patient must be immediately referred for catheterization. In healthcare institutions that has no structure to perform catheterization, the patient with an altered ECG usually receives thrombolytic treatment and is referred to a hospital with structure. However, about 36% of patients who undergo catheterization have normal coronary angiography, which usually indicates that there is no infarction. The ECG can provide valuable information for the diagnosis of MI, but according to the Brazilian Society of Cardiology about 50% of patients with MI do not have a diagnostic ECG, generating a high risk of false negative (FN).In addition to the ECG, risk scores indicate the measurement of cardiac troponin (cTn), in its two isoforms, cTnI and cTnT, established as the gold standard biomarker to assist in the diagnosis of MI, providing more sensitivity than CK-MB. However, as current laboratory tests take more than 1 hour, troponin has been underutilized. The rapid troponin test is a fundamental tool to support the diagnosis of MI and can help hospitals to reduce the number of coronary angiography and unnecessary thrombolytic treatments, in addition to providing rapid values for reperfusion criteria monitoring in medicated patients. For patients without an altered ECG, the rapid troponin test can reduce the risk of FN and shorten the waiting time until treatment begins. The most promising solution to provide information on troponin levels within the recommended time (<1 hour) is the development of a point of care (PoC) device that presents accurate results (coefficient of variation) <10%) in less than 10 minutes. A proof of concept of the solution was developed and tested on a bench, showing a coefficient of variation (CV) of ~ 7% with an incubation time of 8 minutes. The development of a device that reproduces the results found in bench tests in an automatic and easy way is the main point of this project. The device resulting from this project shall be made available to the 7,971 hospitals with emergency care in Brazil, in addition to the 1,245 Emergency Care Units (UPAs) and 5,372 ambulances, being able to perform about 820 thousand tests per year. The intended business model is the supply of the device in lending and the sale of a consumable lancet for testing, having a sustainable recurrence model and enabling access to the troponin test without the need for initial investment for healthcare institutions. (AU)