The Fujirebio Lumipulse G is an automated chemiluminescent enzyme immunoassay (CLEIA) platform designed for quantitative measurement of biomarkers in clinical laboratory settings. Developed by Fujirebio, a Japanese in vitro diagnostics company, the Lumipulse G system received significant attention for its role in Alzheimer's disease biomarker detection, particularly for cerebrospinal fluid (CSF) assays measuring amyloid-beta and tau proteins[1].
The platform uses a two-step sandwich immunoassay format with magnetic bead-based technology, providing high sensitivity and precision for detecting low-abundance biomarkers in biological fluids[2]. Lumipulse G instruments are designed for high-throughput clinical laboratory use, with automated sample handling and results reporting integrated with laboratory information systems (LIS)[3].
Lumipulse G β-Amyloid 42/40
Lumipulse G Total Tau (t-Tau)
Lumipulse G Phospho-Tau (p-Tau181)
Lumipulse G Phospho-Tau (p-Tau217)
The Lumipulse G platform serves as a crucial tool in the Alzheimer's disease diagnostic pathway:
| Feature | Fujirebio Lumipulse G | Roche Cobas Elecsys | Quanterix Simoa |
|---|---|---|---|
| Platform Type | Automated CLEIA | Automated ECLIA | Digital immunoassay |
| Throughput | High (up to 100 tests/hour) | High | Lower (sample-limited) |
| FDA Clearance | Yes (Aβ42/40, t-Tau, p-Tau181) | Yes | Research use only |
| Sample Type | CSF | CSF, plasma | CSF, plasma, serum |
The Lumipulse G platform offers a balance between the high-throughput capability of the Roche Elecsys system and the ultra-sensitive measurements available from digital immunoassay platforms[9].
Fujirebio. Lumipulse G β-Amyloid 42/40. 2024. ↩︎
Nakamura A, Kaneko N, Kato N, et al. Quantitative determination of amyloid β42 in cerebrospinal fluid by chemiluminescent enzyme immunoassay. Clin Chim Acta. 2020. ↩︎
Blennow K, Zetterberg H. Cerebrospinal fluid biomarkers for Alzheimer's disease. Lancet Neurol. 2019. ↩︎
Hansson O, Sehlin D, Svedlund ML, et al. Accuracy of CSF Ab42/40 and p-tau181 for detecting Alzheimer's disease. Brain. 2024. ↩︎
Zetterberg H. Tau protein in cerebrospinal fluid: a diagnostic marker for Alzheimer's disease?. Mol Neurobiol. 2022. ↩︎
Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimer's Dement. 2018. ↩︎
Palmqvist S, Janelidze S, Quiroz YT, et al. Discriminative Accuracy of Plasma p-Tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders. JAMA. 2020. ↩︎
Jack CR Jr, Holtzman DM. Biomarker modeling of Alzheimer's disease. Neuron. 2023. ↩︎
Rissling A, Bidez P, Frölich L, et al. Head-to-head comparison of two automated immunoassays for Alzheimer's disease biomarkers. Clin Chem Lab Med. 2022. ↩︎
Lehmann S, Delaby R, Baux G, et al. Cerebrospinal fluid Alzheimer's disease biomarkers: a cross-sectional study. J Neurol. 2022. ↩︎