How best to support point-of-care testing in the community?

It is now possible to measure glycated haemoglobin or HbA1C with small point-of-care devices that have an analytical quality that is fit for the clinical purposes of both monitoring and diagnosing diabetes. ¹ Given the prevalence of diabetes and the general desire of many healthcare systems to enable more care to take place in primary as opposed to secondary care, there is clearly a potential value proposition to support point-of-care testing (POCT) for HbA1C, particularly in the community or general practice.

While evidence from trials of better glycaemic control in POCT compared to laboratory-tested patients is lacking, ² there are other benefits of HbA1C POCT when a wider range of stakeholders is considered; in observational studies of real-world data, these provide a broader perspective of the value of the test. ³ Not the least of the benefits include improved access to testing and the overwhelming convenience to the patient of requiring only one visit rather than two to get blood collected, tested and to receive a GP consultation based on the HbA1C result. A similar value-based case can be made for the diagnosis of diabetes or high diabetes risk through HbA1C POCT.

Despite this well-described unmet need for HbA1C POCT, there are also some barriers which have prevented more widespread adoption of POCT for HbA1C in countries such as the UK and Australia. ⁴ These include the fact that only some HbA1C POCT devices are fit for clinical purpose and that testing must be conducted according to quality standards or a so-called quality framework. Given that there is an extensive literature which indicates those devices that meet the required standards, it is somewhat perplexing to see a recent publication describing outcomes from using POCT HbA1C as part of the English National Health Service Health Diabetes Prevention Programme and which included the use of one POCT device that has been shown to be not fit for purpose. ⁵ Other recent and relevant developments in the UK include the likely deployment of more community-based POCT as part of the NHS strategy to move towards more integrated care.

In Australia, HbA1C POCT by general practitioners has just been approved for reimbursement by the Federal Government. Only devices that meet the required standards are eligible for reimbursement, and this requirement is incorporated into a quality framework (or POCT standards) which all GPs should adhere to when conducting POCT including some form of accreditation. ⁶ Given some of the challenges described in the literature about the experiences of GPs with POCT, one can speculate on how easily and how well the average Australian GP practice will cope with implementing these quality standards and whether the requisite quality of POCT will be delivered. In recognition of these concerns, perhaps now is the time to consider whether there needs to be more structured involvement of the laboratory profession in the deployment of community POCT in the UK and Australia albeit recognising that this support might take different forms due to the different laboratory testing models in the two countries.

Currently, in the UK, the Medicine and Healthcare Products Regulatory Agency Management and Use of IVD Point-of-care test devices (3 February 2021) states that ‘The local hospital pathology laboratory should play a key role in the development and management of a POCT service. This is particularly true for secondary care and may also be useful for some primary care services’. ⁷ While many UK laboratories provide support for GP and community POCT, there is little information available on the extent of involvement. There is certainly no formal national POCT support structure in place, and what support does exist is somewhat ad hoc and probably variable in extent and quality.

The bulk of community-based pathology in Australia is carried out by commercial laboratories which have concentrated on a centralised model of testing. This has led to GPs in areas outside major cities suffering the tyranny of distance in relation to pathology services. To address this problem of excessive turnaround times for some test results, GPs and other healthcare workers use POCT in many regional and remote areas. Some are supported by two POCT support organisations, the Australian Point-of-Care Testing Network or APPN in South Australia ⁸ and the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services or QAMMS across various States and Territories. ⁹ Both organisations are independent of laboratories but utilise laboratory-trained staff who provide support to ensure POCT is of the requisite quality.

Models of formalised support for community POCT by laboratories exist in several European countries. While the menu of POCT tests in the Netherlands is limited largely to CRP, support for this test is provided through the same commercial pathology laboratories who perform the bulk of laboratory-based testing. The laboratory support includes provision of equipment, reagents and advice to the extent that the GP or practice nurse only has to perform the test, interpret and act upon the result.

The most developed of these POCT support models is provided by the Norwegian service known as NOKLUS. ¹⁰ This commenced as a standalone service albeit with laboratory-trained professionals but has developed a national network that now includes NOKLUS staff based in the local hospital laboratory and thereby provides an elegant model of integrating laboratory and POCT services. Furthermore, they have introduced routine External Quality Assurance across all their GP users, and this is widely acknowledged to be the best way to monitor the quality of HbA1C POCT. ¹ While there is no compulsion for GPs to enrol with NOKLUS, the reality is that the vast majority have willingly enrolled because they see the value of having a reliable POCT service that is managed in a way that leaves them to concentrate on patient care.

While ensuring the quality of the analytical service is the first key requirement of any POCT support network, there is also an opportunity here to take a broader quality perspective and for the same network to monitor some of the other various outcomes that result from POCT. In the case of HbA1C, this would of course include glycaemic control, and once again, NOKLUS has led the way here with its recent publication showing that there is a small but significant improvement in glycaemic control in patients receiving POCT as compared to when they were monitored by the laboratory. ¹¹ However as indicated above, POCT delivers other benefits which contribute to the value proposition, some of which have been measured in a relatively small number of studies but are worthy of more attention and could be integral to a quality improvement programme managed by the POCT support network.

All POCT requires investment to the extent that the initial higher cost of POCT versus the central laboratory requires up-front funding for these costs with the understanding they will be defrayed and ideally exceeded by the downstream benefits of POCT. We believe such investment should include a formal support system, provided by the laboratory or laboratory-trained professionals which can be tailored to the individual needs of the general practice but with the overriding goals of ensuring that testing is of the required quality and the testing outcomes can be monitored. The NOKLUS and Netherlands models show what is possible, and without such support, there is the risk that the initial investment in POCT will be wasted.