Point-of-care testing; The marmite of pathology, crumpets anyone?

KATY HEANEY
POCT Specialty Lead,
Consultant Biochemist,
Berkshire & Surrey Pathology
Services

This article is for the lovers of POCT and maybe some middle grounders who can join us in the path to better POCT – accurate, well governed, resourced and safe POCT. No test is perfect, but an imperfect test can be used if we understand it.

2023 saw some giant milestones reached in the field of Point-of-care testing (POCT) and 2024 has even greater potential for raising the profile. I am aware it is considered the marmite of pathology, loved by some and hated by others, but the toaster has popped, and some are certainly adding it to their crumpets. It is important for Pathology to commit to leading the way in setting out how POCT is used and how to ensure high quality results and safe use for patients.

Guidance for all
National strategic guidance was released by the pathology professional bodies, the IBMS, the Association for Laboratory Medicine and the Royal College of Pathologists in May 2023. A long-awaited document, given the last professional body guidance was released over 10 years ago, the 2023 document covered generic areas of consideration and posed a number of questions to aid consideration of all angles of implementation. Targeted POCT guidance was released by a collaboration of NHS England speciality teams for urgent community response and virtual ward services in August 2023, written more for the commissioners and those working in the service, with multiple reference to working in collaboration with Pathology staff. In 2024 the CSO office is planning to release a framework for POCT implementations in infection diagnostics. I expect more guidance to be released in 2024 to target clinical services and for commissioners of services. I hope for more guidance at integrated care system level to review POCT needs and to bring about further collaboration, again requiring Pathology leadership in this growing area of interest.

National conversations
In July 2023 I was asked to join the NHS England Diagnostics Clinical Advisory group as a POCT specialist. Chaired by Sir Professor Mike Richards this group covers the four diagnostic programme pillars (imaging, pathology, endoscopy and physiological sciences) and the Community Diagnostic Centres (CDCs), providing strategic clinical advice and guidance to support the delivery of diagnostics recovery and renewal, the long-term plan and elective recovery plan. Discussion in this group is wide-ranging and enlightening but leaves no doubt that working in collaboration is essential, combining rapid diagnostics across the pillars equates to greater gains than its individual parts and workforce pressures affect every diagnostic pillar.

In November 2023, the NHS England Pathology Transformation programme invited pathology network leads to the opening meeting of the Pathology POCT subgroup, endorsed by the National Pathology Stakeholder Board this group will provide expertise and governance for IVD POCT within NHS England. National Deputy Director of Pathology, Jane Mills, hopes that this group will help gain a better understanding of the requirements across all of the domains that we are currently using to assess pathology networks; governance, leadership, operational models, quality, digital, workforce, supply chain; but through the lens of the IVD-POCT service. I look forward to the outputs from this group and I hope this contributes to pathology network wide leadership of POCT which from my own experience can bring about significant benefits for clinical pathway harmonisation and financial efficiencies.

It is noteworthy that colleagues in the devolved authorities, particularly Wales, have achieved more national leadership in POCT than England in previous years. I commend their ambition and achievements for example in national IT integration and applaud their ability to provide advice from an expert group. I had the pleasure of seeing a particularly well written response from the Welsh group on the use of POCT devices in the assessment of neonatal hypoglycaemia which I am pleased to say contributed enormously to the soon to be published updated British Association of Perinatal Medicine’s hypoglycaemia framework. The previous guidance rightly ruled out the use of any glucose meters in the assessment of hypoglycaemia, when actually there are now some meters on the market that are capable of accurate low glucose results in trained hands and this can bring about significant benefits including faster results, reducing unnecessary result production from a blood gas profile and a requirement for less blood volume. The guidance states clearly collaboration with pathology on device purchases and understanding the performance of a device is critical.

Collaboration with industry
Relationships between pathology POCT and manufacturers is a bumpy ride at times. Strong leadership in an NHS institution will enable manufacturers to know who to approach and collaborate with to positively implement POCT with good governance and resourced support for services. A lack of leadership from pathology's side leaves gaps in this governance, and sadly some manufacturers have taken advantage, often in my experience to the detriment of long-term implementation of a POCT device due to poor financial clarity. Consequently, in the worst cases, due to poor quality results, services lose confidence in the purchased kit, and resources and time are wasted on both sides.

In October 2023, a new format for collaborative meetings was hosted by the NHS England CSO officers and the National Institute of Healthcare Research Biomedical Research Centre in Leeds, supported by BIVDA and ABHI, spent a day discussing infection diagnostics. With an introduction from Professor Sir Chris Whitty and then a grounding video from a patient ambassador of Antibiotic Research UK about her life with an antibiotic resistant urinary tract infection (Ronda’s story, www.antibioticresearch.org.uk), the mixed attendees from NHS, academia, professional bodies, AHSNs, manufacturers and third-party suppliers attended a series of workshops to discuss the role of infectious diagnostics in acute care and primary care.

The next event in the Moving Forwards Diagnostic series will focus on target product profiles (TPPs) for anti-microbial resistance and infection diagnostics. It is hoped the series will continue with events on regulation, validation and implementation in the future. I look forward to seeing more of this meeting format in which we all take a more active role in informing of the diagnostic need from our manufacturer colleagues, rather than the more passive role of the past of accepting only what is offered.

World-wide
Interest in POCT high-sensitive troponin continues with large scale studies taking place in the USA, Australia and New Zealand. The IFCC Live webinar series in which the Committee on the Clinical Application of Cardiac Biomarkers invites guest speakers to share their knowledge is particularly good for informing on the latest research in this area. I enjoy Dr Paul Collinson’s chairmanship of these and hope for more insight in 2024 as to how this test can benefit the UK NHS system, as I do believe that just introducing a faster device in this pathway will be insufficient in bringing about the benefits our Emergency Department colleagues so sorely need.

My last reflection came about over a festive meal in December. A family member had recently presented at the Vaccine Cold Chain and Technology symposium in Kigali, Rwanda. The pandemic challenged the delivery of routine vaccines by pressurising both the cold chain capacity for vaccine storage and record keeping in remote healthcare settings. POCT tests are being designed to demonstrate immunity, allowing targeted vaccinations, resulting in better use of precious cold chain storage and reduced wastage of vaccine supplies. This is so far apart from the UK POCT routine conversation it helps me put into context our local wobbles over this device or that.