Plasma brain-derived tau: analytical and clinical validation of the first commercial immunoassay Article Swipe
Michel N. Nafash
,
Sarah Svirsky
,
Xuemei Zeng
,
Yijun Chen
,
Julia Kofler
,
Oscar L. Lopez
,
David O. Okonkwo
,
Óscar López
,
Ava M. Puccio
,
Thomas K. Karikari
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1101/2025.07.21.25331193
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1101/2025.07.21.25331193
Background: Brain-derived tau (BD-tau) is a promising blood-based biomarker for neurodegeneration/brain injury in neurodegenerative and acute neurological disorders. However, widespread use is hampered by lack of commercial assays. Methods: Using the Simoa HD-X analyzer, we evaluated the first commercial research-use only BD-tau Advantage PLUS assay's robustness, precision, dilution linearity, spike recovery, specificity, and limits of detection. Matrix effect was examined by comparing BD-tau levels in n=48 plasma/serum and n=20 plasma/CSF sample pairs. Clinical performance was examined in a traumatic brain injury (TBI) cohort. Results: Twenty repeated measurements of three plasma samples gave intra- and inter-plate CVs ≤7.24%. A median drift of 8.00% (decrease) was observed from the start to the end of a full plate run. Analytically, BD-tau concentrations decreased linearly up to 16-fold dilution, spike recovery was 86-96%, and signals were highly specific to the CNS-abundant tau441 but not the peripherally-enriched "big-tau" isoform. Moreover, signals were stable for up to four freeze/thaw cycles. Furthermore, significant correlations were observed in the plasma/serum (r=0.8392; p<0.0001) and plasma/CSF (r=0.6150; p=0.0039) pairs. Finally, plasma BD-tau was elevated in severe-acute TBI vs. chronic-mixed TBI and unaffected controls (p<0.0001; AUC=0.9986, and p<0.0001; AUC=1.000, respectively). In severe-acute TBI patients, plasma BD-tau was correlated with plasma p-tau217 (r=0.5761, p=0.0005), NfL (r=0.8910, p=0.0001), and GFAP (r=0.5424, p=0.0011). CSF BD-tau and CSF p-tau217 were strongly correlated (r=0.9667, p=0.0002). Conclusion: BD-tau Advantage PLUS produces robust brain-derived tau-specific readings that demonstrate utility in detecting severe-acute TBI.
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Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.1101/2025.07.21.25331193
- https://www.medrxiv.org/content/medrxiv/early/2025/07/21/2025.07.21.25331193.full.pdf
- OA Status
- green
- References
- 32
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4412543628
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4412543628Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1101/2025.07.21.25331193Digital Object Identifier
- Title
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Plasma brain-derived tau: analytical and clinical validation of the first commercial immunoassayWork title
- Type
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preprintOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-07-21Full publication date if available
- Authors
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Michel N. Nafash, Sarah Svirsky, Xuemei Zeng, Yijun Chen, Julia Kofler, Oscar L. Lopez, David O. Okonkwo, Óscar López, Ava M. Puccio, Thomas K. KarikariList of authors in order
- Landing page
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https://doi.org/10.1101/2025.07.21.25331193Publisher landing page
- PDF URL
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https://www.medrxiv.org/content/medrxiv/early/2025/07/21/2025.07.21.25331193.full.pdfDirect link to full text PDF
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YesWhether a free full text is available
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greenOpen access status per OpenAlex
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https://www.medrxiv.org/content/medrxiv/early/2025/07/21/2025.07.21.25331193.full.pdfDirect OA link when available
- Concepts
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Traumatic brain injury, Biomarker, Internal medicine, Neurodegeneration, Medicine, Cerebrospinal fluid, Immunoassay, Tau protein, Gastroenterology, Chemistry, Alzheimer's disease, Immunology, Disease, Psychiatry, Biochemistry, AntibodyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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32Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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