Revolutionizing Patient Care: The i-STAT Alinity System

Abbott's Innovative Point-of-Care Testing Device

The i-STAT Alinity System is a response to the urgent need for faster diagnostic results. It was inspired by patients who had to wait for their blood results before their medical treatment could commence. The device is particularly beneficial for premature babies in Neonatal Intensive Care Units, patients in intensive care units, and elderly individuals in remote areas with limited access to labs.

What sets the i-STAT Alinity System apart from other devices is its portability and comprehensive range of blood tests. The device boasts an ergonomic and durable design, a large, bright, color touch screen, lights and sound notifications, and a high-resolution camera. It can be used in various care settings such as hospitals, ambulances, urgent care, or remote areas. Furthermore, all materials used in the device are compliant with European Reduction of Hazardous Substances and European Waste Electrical and Electronic Equipment regulations.

The i-STAT Alinity System is composed of several subsystems including an analytical measurement module, a user module, a user interface, and a rechargeable battery. The device uses i‑STAT single-use cartridges containing electrodes and sensors to perform quantitative diagnostic testing on whole blood. The testing process is carefully monitored and controlled by the device, requiring minimal user intervention.

The project, which started in 2011, received FDA clearance of the instrument and sodium assay in July 2016. The product was designed, developed, and tested in Princeton, New Jersey, USA and Ottawa, Canada. Sodium, glucose, and hematocrit assays were used to demonstrate the analytical functioning of the i-STAT Alinity instrument. The research included multi-day precision, linearity, analyte recovery, limit of quantitation (LoQ), and interference from potential substances.

One of the biggest challenges in developing the i-STAT Alinity System was delivering lab-quality results typically expected of larger instruments in a handheld device. The device needed to be portable and lightweight, yet capable of providing lab-quality results. This challenge was successfully overcome, resulting in a device that can be easily transported from patient to patient in a hospital, clinic, or ambulance.

The i-STAT Alinity System has been recognized for its innovation, receiving the Silver A' Medical Devices and Medical Equipment Design Award in 2017. This award is given to top-of-the-line, creative, and professionally remarkable designs that demonstrate outstanding expertise and innovation. Abbott's i-STAT Alinity is a testament to the power of design in improving patient care and revolutionizing the medical field.