Multicenter validation of plasma p-tau217/ amyloid beta 1-42 ratio in symptomatic Alzheimer's disease.

Cohort studyAlzheimer's & dementia : the journal of the Alzheimer's Association· Jul 2026

Multicenter validation of plasma p-tau217/ amyloid beta 1-42 ratio in symptomatic Alzheimer's disease.

Abhay R Moghekar, James A Rock, Richard C Mohs … Douglas M Hawkins

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Neurologic ImagingCohort studyDiagnosisQ1IF 11.9

Plasma p-tau217/amyloid ratio detected amyloid pathology with 97.6% sensitivity, 90.8% specificity.

Multicenter validation of plasma p-tau217/ amyloid beta 1-42 ratio in symptomatic Alzheimer's disease.

Abhay R Moghekar … Douglas M Hawkins

Alzheimer's & dementia · Jul 2026

Background

This study evaluated the diagnostic performance of the Lumipulse ® G Tau 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 (cerebrospinal fluid) biomarker ratios or amyloid positron emission tomography (positron emission tomography) imaging as references in 499 adults (≥50 years old) enrolled in prospective studies conducted across academic memory clinics and research centers.

n = 499 adults

Results

correctly identified amyloid pathology in nearly all true-positive cases

97.6%

Sensitivity

90.8%

Specificity

More results

Amyloid status was determined by cerebrospinal fluid in 347 patients (189 positive [54.5%]) and by positron emission tomography 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%).

“

Conclusion

DISCUSSION: The US Food and Drug Administration-cleared Lumipulse Plasma Ratio demonstrated high accuracy in identifying amyloid pathology and offers an alternative to cerebrospinal fluid testing and amyloid positron emission tomography imaging.

Multicenter validation of plasma p-tau217/ amyloid beta 1-42 ratio in symptomatic Alzheimer's disease.

Multicenter validation of plasma p-tau217/ amyloid beta 1-42 ratio in symptomatic Alzheimer's disease.

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