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Food and Drug Administration or any other regulatory agency. The good news is that several immunoassays and mass spec tests for amyloid can meet these standards. The twist? If that sounds circular, read on …. Performance Standards: Check Getting a timely diagnosis has become ever more urgent with the rollouts of lecanemab and donanemab. Anticipating these approvals, the Global CEO Initiative in convened a blood biomarker BBM workgroup to develop minimum performance standards for amyloid pathology tests.

Co-lead by Schindler and Hansson, the group included dementia biomarker specialists, clinicians, and stakeholders from academia, industry, private foundations, and advocacy groups.

Louis; Eisai Inc. Agree to what? The consensus performance recommendations the workgroup issued depend on the reason a given test will be used. For example, to confirm a suspected diagnosis of AD, the recommendations stipulate that the test should perform as well as approved tests of cerebrospinal fluid, namely having a specificity and a sensitivity of 90 percent. For a triage test, aka a test that will be confirmed with follow-up amyloid PET or CSF analysis, the sensitivity should still be 90 percent.

As for its specificity, greater than 85 percent would suffice in primary care. For secondary care, that specificity could be even less stringent, at 75 percent, depending on what further testing is available table below. The paper goes into considerable depth explaining how specificity, sensitivity, positive and negative predictive values, and area under the curve are calculated and what they mean.