BLOOD SCIENCES
then pathway design itself becomes part of diagnostic quality. As testing becomes more decentralised, controlling that pathway remains just as important, even if its nature changes. It also reinforces the importance of
collaboration between laboratory teams, clinical services and technology providers. Introducing a new testing model cannot simply be a mater of implementing a device. Patient preparation, sample collection, measurement, quality assurance, reporting and clinical interpretation must be considered as connected components of a single diagnostic pathway. With the NHS 10-Year Plan promoting the shift from hospital to home, implementing an OGTT pathway that is not prone to glycolysis will be critical to ensure clinical effectiveness. OPHELIA and other studies show how fragile the OGTT pathway can be.
An opportunity to improve an established pathway The OPHELIA study does not suggest that the OGTT itself should be replaced. The researchers also investigated HbA1c at 28 weeks as a potential alternative but found that it did not perform sufficiently well as a standalone diagnostic test. Instead, the evidence points towards
improving the pathway around a test that remains the gold standard but that can be undermined relatively easily. In particular, the need for timely centrifugation of samples should be noted; sample tube manufacturers advise that centrifugation is essential for the tubes to prevent glycolysis. For some laboratories, that may
Samples collected in antenatal clinics, hospital phlebotomy departments or community services may have different transport arrangements, processing procedures and time intervals
mean reviewing local sample-processing procedures and auditing the time between collection and processing. For healthcare systems, it may mean considering whether elements of OGTT testing can be delivered closer to the patient. For diagnostic providers, it means developing technologies capable of delivering reliable measurements within appropriate laboratory and clinical governance frameworks. These approaches are not mutually
exclusive. Improving pre-analytical practice within conventional pathways and developing validated alternatives to their delivery both address the same underlying objective: ensuring that the glucose result on which a clinical decision is based is accurate and representative of disease status.
The OPHELIA findings provide a
powerful reminder that diagnostic quality does not begin at the analyser — and it does not end there either. For GDM, what happens between the patient and the result can influence who receives a diagnosis. As diagnostics increasingly move across laboratories, clinical setings
and patients’ homes, the challenge for pathology is therefore not simply to protect laboratory standards within the laboratory. It is to ensure those same standards of accuracy, quality and clinical confidence follow the test wherever it is delivered.
James Jackson is Founder and CEO of Digostics, a UK-based digital clinical diagnostics and diabetes home testing company. A biochemist and immunologist, he has worked in the diagnostics and life sciences sector since the mid-1980s, including roles at Genzyme and Novo Nordisk, where he developed early expertise in hormone assays and diabetes-related diagnostics. Over his career, he has contributed to the development of a wide range of diagnostic technologies across immunoassay, enzymatic and biosensor platforms, and is an inventor of several novel testing systems, including Digostics’ GTT@home solution. He continues to lead the company’s product development and research in collaboration with clinical partners to advance innovation in diabetes diagnostics.
www.digostics.com
PPi
October 2026
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