Abstract
INTRODUCTION
This study evaluated the diagnostic performance of the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio to detect amyloid positivity in patients with cognitive decline symptoms.
METHODS
The Lumipulse Plasma Ratio was evaluated using predetermined thresholds (≤0.00370 negative; ≥0.00738 positive) against cerebrospinal fluid (CSF) biomarker ratios or amyloid positron emission tomography (PET) imaging as references in 499 adults (≥50 years old) enrolled in prospective studies conducted across academic memory clinics and research centers.
RESULTS
Amyloid status was determined by CSF in 347 patients (189 positive [54.5%]) and by PET imaging in 152 patients (66 positive [43.4%]). The Lumipulse Plasma Ratio was positive in 219 patients (43.9%), negative in 182 (36.5%), and indeterminate in 98 (19.6%). Positive and negative predictive values were 91.8% and 97.3%, with a sensitivity and specificity of 97.6% and 90.8%, respectively.
DISCUSSION
The US Food and Drug Administration-cleared Lumipulse Plasma Ratio demonstrated high accuracy in identifying amyloid pathology and offers an alternative to CSF testing and amyloid PET imaging.
If you do not see content above, kindly GO TO SOURCE.
Not all publishers encode content in a way that enables republishing at Neuro.vip.
This post is Copyright: | July 9, 2026
Neuro-Dementia