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. 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, 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. 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 valuebased 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. 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. 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. 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’. 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