With therapeutic advances for individuals with high amyloid, more labs are developing tests, globally. As more labs offer testing and more patients seek tests, this program ensures high quality and reproducible testing is done across labs. Although regulatory clearance of testing has provided some control, the volume of testing, diversity of available platforms, and shift from research to clinic creates a greater need to expand this program to more labs.

External quality control (QC) testing ensures laboratory accuracy and reliability by comparing test results to an external standard or peer group. These types of programs have helped identify systematic errors, assess performance trends, maintain regulatory compliance, and improve individual laboratory methodology. The Alzheimer’s disease quality control (QC) program was initially launched in 2009, with the aim to establish a tool to monitor the performance of CSF biomarker measurements across clinical laboratories and large research laboratories, and protect against longitudinal drift and batch-to-batch variations. The program has since grown to include blood biomarkers and multiple platforms. DxA funding for this project will enable expansion of the program beyond the current 150 labs and ensures quality control can be offered beyond the 6 platforms available. As testing and treatment becomes more widespread, quality control and proficiency testing programs such as this will become a regulatory necessity to guarantee high quality testing across labs.