Project-COMFORT

Blood tests are a common feature of patient care and clinical studies. Yet having a blood test still requires the patient to go to a hospital or clinic and this can be burdensome, especially for people who require regular tests. But what if patients or their caregivers could collect a blood sample in the comfort of their own home and simply send it to the lab for analysis?

Turning this vision into a reality is the ultimate goal of Project-COMFORT. The project focuses on patient-centric microsampling techniques, which collect less than half a millilitre of blood.

While microsampling devices already exist, they are not widely used and questions remain on issues such as how to manage the logistics of sending samples in the post, whether the amount of blood collected is enough to run certain tests, and whether the results are accurate.

Project-COMFORT aims to co-create and test the logistics, infrastructure and tools needed to make microsampling a standard part of healthcare and an acceptable alternative to conventional blood tests.

As a first step, the project will set up infrastructure and workflows for microsampling. The starting point for this effort will be existing microsampling devices covering different types of blood tests (including standard blood counts, measures of organ function, hormones, and tests for drugs that are therapeutically monitored). Experts in logistics and microsampling devices will collaborate with representatives of primary care providers, laboratories, regulators and the patient community to develop logistical and infrastructure approaches to integrate the use of these devices into clinical studies and healthcare.

Crucially, the project will carry out a clinical study with human participants to assess how well the results from microsampling devices match results from standard blood tests. The project will work closely with patients to ensure that they are comfortable with the devices as well as the practicalities of collecting and sending off their own blood samples.

Microsampling devices touch on several different regulatory pathways, so the project will work with regulators at both European and national level (linking to the UK and US regulators as well) to deliver a single, harmonised regulatory pathway for the uptake and use of microsampling in clinical studies and healthcare systems.

To ensure the project results are taken up and used, the Project-COMFORT team will create an open knowledge hub featuring scientific findings, data, logistical tools and assessment measures on microsampling.