Enabling patient-centred sampling: total laboratory automation

Patient Public Involvement in laboratory science is not common place across the UK. As laboratory-based professionals, clinical scientists tend to stay within the confines of our comfort zone: within the lab and patients are very much experienced as case records associated with bar codes on tubes.

The NHS is very good at force-fitting existing processes and pathways onto our patients, but times have changed and technology now exists the can enable us to deliver blood sciences services in ways we never encountered before. New technology and policies for delivering healthcare, including diagnostics means we need to move away from our benches and build good working relationships with the patient groups that we serve. We need to find out what works best for them. What are the main barriers to access simple blood tests and what changes can we make to enable easier and more equitable delivery of our diagnostic service?

Engaging patient conversation in these matters is of huge value. This can be done through joining ward rounds, sitting in on specialist clinics and discussions with GPs and phlebotomy teams to find out where and how patients are talking about their healthcare. There are often a few patients who are willing to then work with you to redesign a delivery model that would work better for their patient group and even help promote your work!

‘Laboratory Social Science’ needs to now be embedded within our service development processes to build real health equity when it comes to simple blood tests. Remember that behind every blood sample there is a story.

Project-COMFORT: Co-creating and testing the set-up to make Patient Centric micro-sampling (PCmS) an available option across European healthcare systems and decentralized trials

Kathleen will outline the development and commercialization journey of the LetsGetChecked ImPress, a single-use blood-lancing device designed as a modern alternative to traditional finger-prick blood draws. Awarded the 2024 Red Dot Award for Innovative Product Design, the ImPress device prioritizes a patient-centric experience while producing optimal capillary whole blood samples of up to 600ul.

A core focus of the ImPress's development was engineering a reliable and highly scalable device. The technology utilizes stroke mechanisms to create a gentle vacuum, which significantly reduces hemolysis and ensures consistent, high-quality samples. Guided by a "50% Rule," the design integrates proven off-the-shelf components with cutting edge and patented design features. Use of pre-sterilized lancets and standard collection tubes cuts research and development timelines, and utilization of snap-fit assembly methods help seamlessly transition from manual assembly to high-throughput production.

Furthermore, the device was iteratively engineered for usability and human factors. Through continuous small-scale user testing and Instructions for Use (IFU) refinements, the ImPress incorporated features like a familiar telescopic design, an audible "click" for activation feedback, and a progress viewport for clutter-free monitoring. The resulting intuitive device simplifies blood collection for users while remaining compatible with standard laboratory workflows.

Finally, she covers the device's regulatory milestones. The ImPress currently holds FDA 510(k) clearance for utilization by healthcare professionals, with further FDA clearance for at-home HbA1C testing and CE marking currently pending.

Patient-centric sampling refers to the method of collecting small volumes of blood, saliva, or urine using micro-sampling devices, allowing for more convenient healthcare access for patients. Blood samples can be obtained through finger pricks or various devices placed on different parts of the body. Although the volumes collected are small, they should suffice for the necessary analyses required for patient care. However, several challenges must be addressed before this approach to blood testing can achieve wider acceptance and routine implementation. These challenges include the need for clinical education on test reliability, advancements in automation and assay development, improved validation data from analyser manufacturers, and enhanced interpretation methods for capillary testing. These topics will be further explored in the presentation.