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Evidence-based standardized sample handling protocol for accurate blood-based Alzheimer's disease biomarker measurement: Results and consensus of the Global Biomarker Standardization Consortium
Inge M W Verberk, Mariam Gouda, Daniel Antwi-Berko, Mardou van Leeuwenstijn, Bram Bongers, Isabel M Houtkamp, Wiesje M van der Flier, Shorena Janelidze et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025-10
Topic: Plasma and spinal-fluid biomarkers
All assessed BBM levels varied by over 10% by collection tube type. Aβ peptides were the most sensitive, and their levels declined >by more than 10% under storage and centrifugation delays, more steeply at room temperature (RT) compared with 2°C to 8°C. NfL and GFAP levels increased by more than 10% upon RT/-20°C storage. pTau isoforms demonstrated stability across most pre-analytical variations. We established an evidence-based handling protocol to ensure reliable sample handling for neurological BBMs upon adoption in clinics, trials, and research. HIGHLIGHTS: Sample handling protocols can mitigate pre-analytical effects on BBM results. We developed an evidence-based, expert-consensus plasma sample handling protocol. Primary collection tube and delays to centrifuging or freezing impact AD BBMs. Plasma pTau217 is highly resistant to pre-analytical sample handling variations. Plasma Aβ42 and Aβ40 were most sensitive to pre-analytical variations.
Key findings
- All assessed BBM levels varied by over 10% by collection tube type.
- Aβ peptides were the most sensitive, and their levels declined >by more than 10% under storage and centrifugation delays, more steeply at room temperature (RT) compared with 2°C to 8°C.
- NfL and GFAP levels increased by more than 10% upon RT/-20°C storage. pTau isoforms demonstrated stability across most pre-analytical variations.
- We established an evidence-based handling protocol to ensure reliable sample handling for neurological BBMs upon adoption in clinics, trials, and research.
- HIGHLIGHTS: Sample handling protocols can mitigate pre-analytical effects on BBM results.
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Study details
- Participants15
- Evidence strengthLow
How this study scored 54/100
Published in a leading specialty journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 30 of the 56 points we could judge it on, which is 54 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 15 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41025225) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 30 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 30 of the 56 points we could judge it on is 54 out of 100. |
| Total | 54 / 100 | — |
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Verberk, I. M. W., Gouda, M., Antwi-Berko, D., van Leeuwenstijn, M., Bongers, B., Houtkamp, I. M., et al. (2025). Evidence-based standardized sample handling protocol for accurate blood-based Alzheimer's disease biomarker measurement: Results and consensus of the Global Biomarker Standardization Consortium. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.70752
Vancouver
Verberk IMW, Gouda M, Antwi-Berko D, van Leeuwenstijn M, Bongers B, Houtkamp IM, et al. Evidence-based standardized sample handling protocol for accurate blood-based Alzheimer's disease biomarker measurement: Results and consensus of the Global Biomarker Standardization Consortium. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2025. doi:10.1002/alz.70752. PMID: 41025225.
BibTeX
@article{verberk2025-41025225,
author = {Verberk, Inge M W and Gouda, Mariam and Antwi-Berko, Daniel and van Leeuwenstijn, Mardou and Bongers, Bram and Houtkamp, Isabel M and van der Flier, Wiesje M and Janelidze, Shorena and others},
title = {{Evidence-based standardized sample handling protocol for accurate blood-based Alzheimer's disease biomarker measurement: Results and consensus of the Global Biomarker Standardization Consortium}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2025},
doi = {10.1002/alz.70752},
pmid = {41025225},
url = {https://doi.org/10.1002/alz.70752}
}