The Rising Requirement for Developing POC Tests for Hemostasis
Author: Luca Vita
The Rising Requirement for Developing POC Tests for Hemostasis
Several decades ago, the world of clinical diagnostics was revolutionised with the centralisation of diagnostics laboratories. This was spurred by developments in automation, the installation of sample transport systems and the introduction of communication between hospital and laboratory IT systems (1). However, today with new advancements in technology such as novel sensors and miniaturisation, a decentralised trend can be observed in the form of point of care testing (POCT). However, the need for POCT appears to have missed the mark. A recent international survey found that the most commonly used POCT were urine pregnancy tests and blood glucose monitors, when in fact clinicians desired greater use of POCT to diagnose acute cardiac disease, including hemostatic monitoring (2).
Why are we seeing an increase in demand for Hemostatic monitoring?
One of the key driving factors, if not the most prominent, is the continued global rise in prevalence of cardiovascular disease and blood related disorders. An astonishing one third of all global deaths in 2019 were a result of cardiovascular disease (3). Coagulopathy, any derangement of hemostasis, is extremely common amongst patients critically ill with various cardiovascular diseases and therefore management of hemostasis has become a critical part of healthcare. The implementation of POCT over laboratory testing for hemostatic management found a decrease in the requirement for a blood transfusion, and an increase in the overall patient outcome (4). This is in part due to the rapid production of results that is possible via POCT, that allows for quick and accurate decisions to be made by clinicians regarding the most appropriate healthcare.
According to the World Health Organization (WHO) guidelines, an ideal POCT device should meet the ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid/robust, equipment-free, and deliverable for end users) (5). Our novel Gii-sens technology takes advantages not only of the remarkable properties of graphene but also the 3D Graphene Foam’s production on readily available materials; the former advantage refers to the graphene’s high conductivity and enhanced sensitivity whereby small concentrations of biomarkers can be detected due to the increased porosity of 3D Graphene Foam. The technology of 3D Graphene Foam production allows for affordable devices to be scalable, keeping a low production cost, yet maintaining high performance through the easy at which functionalisation of the surface is possible.
As previously mentioned, the ability of POCT to produce rapid results is just one imperative concept in the settings in which the rising demand for hemostatic POCT is coming from. The greatest pressure for development comes from intraoperative settings, intensive care units (ICU), or via outpatients with chronic illnesses or medications that can be managed at home or the bedside with the help of POC testing. As well as producing rapid results the introduction of POCT for hemostasis has introduced whole blood sampling, without the need for sample preparation (6). This allows whole blood samples to be analysed, giving a more complete picture of hemostasis, and providing more accurate management in high stake situations such as in an ICU or during a surgical procedure. Furthermore, eliminating the need for sample preparation helps reduce the protocol which ultimately reduces the time and cost of each test. In terms of designing devices with our Gii-Sens technology, there is the potential to integrate multiplexing aspects for on-site diagnostics for POC biosensors.
One of the biggest disadvantages of POCT compared to more traditional laboratory testing is the precision of the tests. However, due to modern advances in technology the gap is being closed, with the development of more accurate sensors (7). One such advancement comes from the development of novel materials like Gii, the world’s first 3D graphene foam. The 3D structure of the product means that it has a very large electrochemically active surface area, allowing for a larger saturation of recognition molecules. This increases the chances of a binding event to occur and increases the precision of the test. Incorporation of such a material into point of care tests would help bridge the gap bench and bedside testing.
Integration of novel products such as Gii-Sens into hemostatic monitoring assays is made easy due to its ability to be integrated into any biological assay. Such integrations could help meet the rising demand of hemostatic point of care testing in the most appropriate settings and help raise healthcare to meet current global demands.
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