Point-of-care diagnostics: an advancing sector with nontechnical issues

摘要

The particular reasons for the relative lack in development of point-of-care (PoC) diagnostics inna business context were discussed in our sister journal, Expert Review of Medical Devices, overn2 years ago. At that time, it could be seen that the concept of PoC testing was being revisitednfor at least the fifth time in the last 20 years. There had been important advances in technologynbut, with changes in global healthcare structures and funding, the overall in vitro diagnosticsnsector has had sluggish growth. Only molecular diagnostics and PoC testing are growing strongly.nPoC testing is now a quarter of the total global in vitro diagnostics market, but largely due tonuse in diabetes monitoring. An increased focus on areas other than glucose self-testing hasncreated a disturbance in the market. An implementation issue from this disturbance is that ofncontrol between central laboratories and the proposed sites for PoC testing. Evidence is presentednto show that the first step is likely to be increased use in clinics and outpatient facilities closelynlinked with the laboratory. The aim will be to control the quality of the test, maintenance ofnequipment and provide support for the clinician in interpretation. The major problem for effectivenPoC implementation will be the significant changes to patient pathways that are required. Thenchanges will benefit the patient and clinical outcomes but will require healthcare professionalsnto change their work patterns. This will be an uphill task!