Considerations for Interpretation of Research Use Only (RUO)-Generated Data Relative to the FDA-Cleared Lumipulse® G pTau217/β-Amyloid 1-42 Plasma Ratio In Vitro Diagnostic (IVD) Test

Data generated using RUO versions of the Lumipulse® G pTau217 Plasma assay and the Lumipulse® G β-Amyloid 1-42-N Plasma assay should not be interpreted using the thresholds established for the FDA-cleared Lumipulse® G pTau217/β-Amyloid 1-42 Plasma Ratio IVD test. These thresholds were derived and validated within the context of the test system (assay components and platform), its analytical performance characteristics, and the intended use population defined in the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio instructions for use.

Application of thresholds established for the Lumipulse® G pTau217/β-Amyloid 1-42 IVD Plasma Ratio to RUO-generated data, particularly from sample sets that may not fully reflect the intended use population and conditions of use, may result in misclassification and does not represent the clinical performance characteristics of the FDA cleared test.

During the recent product hold and re-release process, the underlying issue affecting the Lumipulse G pTau217 Plasma assay component of the ratio test was identified and corrected. In this context, results generated using RUO configurations of the Lumipulse G pTau217 Plasma assay may not be directly comparable to those obtained with the current FDA-cleared Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio IVD test, and caution is warranted when interpreting such data.

Importantly, ongoing and previously generated datasets using RUO assays continue to represent valuable, scientifically meaningful, and internally consistent research resources within their intended use context.

Note: This announcement applies to the dataset labeled, “UPENN – Plasma Biomarkers (AB42, AB40, ptau217, NfL, GFAP) measured by Fujirebio & Quanterix” in the ADNI-LONI repository.