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March 16, 2024Alzheimer s & Dementia122 citationsOpen Access

Clinical validation of the PrecivityAD2 blood test: A mass spectrometry‐based test with algorithm combining %p‐tau217 and Aβ42/40 ratio to identify presence of brain amyloid

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MMMatthew R. MeyerKKKristopher M. KirmessSEStephanie Eastwood

Key Points

  • The PrecivityAD2 blood test accurately identifies brain amyloidosis, matching positron emission tomography results across diverse patient demographics without performance loss.
  • Yielding an AUC-ROC of 0.94, the Amyloid Probability Score 2 achieved 88% agreement with amyloid PET across 583 individuals with suspected Alzheimer's disease.
  • High-throughput mass spectrometry assays measured plasma %p-tau217 and amyloid beta ratios, providing a clinically validated tool to guide disease-modifying therapies.

Abstract

With the availability of disease-modifying therapies for Alzheimer's disease (AD), it is important for clinicians to have tests to aid in AD diagnosis, especially when the presence of amyloid pathology is a criterion for receiving treatment. High-throughput, mass spectrometry-based assays were used to measure %p-tau217 and amyloid beta (Aβ)42/40 ratio in blood samples from 583 individuals with suspected AD (53% positron emission tomography PET positive by Centiloid > 25). An algorithm (PrecivityAD2 test) was developed using these plasma biomarkers to identify brain amyloidosis by PET. The area under the receiver operating characteristic curve (AUC-ROC) for %p-tau217 (0.94) was statistically significantly higher than that for p-tau217 concentration (0.91). The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status. The PrecivityAD2 blood test showed strong clinical validity, with excellent agreement with brain amyloidosis by PET.

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Cite This Study

Meyer et al. (2024) studied this question.

synapsesocial.com/papers/68e73b88b6db6435876b4e51https://doi.org/10.1002/alz.13764
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