An international effort has made significant progress in diagnosing Alzheimer’s disease (AD) by developing automated tests to measure certain proteins, such as total tau (t-tau) and phosphorylated tau (p-tau), in the cerebrospinal fluid (CSF). These proteins, along with another marker called Aβ42/Aβ40, help understand and diagnose AD pathology. Combined with a clinical evaluation, these tests help to support if an individual would benefit from recently development disease modifying therapies (DMT). These tests can be quite different in their technology and to ensure they are reliable and consistent across different labs; scientists are working together to standardize them. This collaboration aims to improve the accuracy of AD diagnosis and support research and treatment development.

Given the need for easier and more affordable diagnostic tools, the focus is now on measuring the same proteins in blood. This will significantly reduce the reliance of expensive molecular imaging and invasive CSF testing, which both require specialised attention, and increase the speed of patients’ management and care. Our recent work has shown that specific forms of p-tau in blood, like p-tau217, are particularly effective in diagnosing AD. A major study involving 33 different blood tests for p-tau confirmed that these tests could accurately distinguish AD cases from non-AD cases. Importantly, the best performing tests gave very values. This finding suggests that it’s possible to standardize these blood tests across different testing platforms.

With strong support from research and the availability of new tests, there’s an urgent need to standardize p-tau217 blood tests for global clinical use. The proposal seeks funding to work with the International Federation of Clinical Chemistry (IFCC) to standardize these tests. This involves conducting new studies to ensure the tests work well across various platforms and developing certified reference materials (CRM) to guarantee accuracy, consistency and global agreement on AD diagnosis.