Hopolang Mokhopi
THE World Health Organisation (WHO) has released guidelines, known as Preferred Product Characteristics (PPC), for blood-based diagnostic tests for Alzheimer’s disease (AD).
Developed with a group of 20 leading scientists, these guidelines aim to help create affordable and effective tests suitable for global use, including in low- and middle-income countries (LMICs).
The PPC draft was opened for public input in 2024, receiving comments from 18 contributors, including individuals living with dementia. Their insights helped shape the guidelines, ensuring the tests are user-centred and suited for real-world application.
According to the WHO report released last week, the PPC guidelines target developers, funders, and regulatory agencies to ensure that blood-based diagnostics achieve high clinical accuracy and are accessible in various healthcare settings.
“The ultimate goal is to improve early detection and support for AD, particularly where access to specialised diagnostics, like imaging and cerebrospinal fluid (CSF) analysis, is limited.
“Receiving a timely and accurate AD diagnosis is a prerequisite for accessing services and support for the person, families and care partners,” part of the report stated.
Dementia, with AD accounting for 60-70% of cases, is a leading cause of disability and deaths worldwide, affecting over 55 million people.
Currently, diagnosing AD depends largely on clinical evaluations, which are often limited by resource constraints in LMICs. Blood-based biomarkers, however, have shown promise for earlier detection, greater accuracy, and cost-effectiveness.
The WHO said the future tests should be tailored to diverse settings, especially given the anticipated rise in dementia cases in LMICs. The PPC specifies clinical accuracy, the target population, and essential considerations like age, gender, genetic factors, and other conditions that might impact results.
“The use of blood-based biomarkers therefore has enormous potential to support health systems in improving the diagnosis of AD. This is especially relevant in settings where the size of the specialised healthcare workforce is significantly low and health system infrastructure and funding are unable to provide specialised neurological services sustainably to populations,” the report said.
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